Medical Writer Resume Samples

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C Dare

Cornelius

Dare

3126 Rempel Ridges

Los Angeles

+1 (555) 286 2319

3126 Rempel Ridges

Los Angeles

Phone

p +1 (555) 286 2319

Experience Experience

Phoenix, AZ

Medical Writer

Phoenix, AZ

Ziemann-Gleichner

Phoenix, AZ

Medical Writer

Collaboration with management team to provide training to Medical Writers to ensure best working practices are maintained
Develops and manages timelines for document development
Provide constructive feedback to investigators to improve clarity, logic, and persuasiveness of grant proposals
Reliance on instructions, templates, and pre-established guidelines (eg, Standard Operating Procedures) will be expected to perform the above functions
Provide medical advice/expertise across many therapeutic areas (internally and externally) and quickly develop expertise in new therapeutic areas
Perform literature searches/reviews and research current guidelines as necessary to gather background information and training for development of documents
Contribute to the development of frameworks, modules, templates, and general guidelines for IRCs, reviewer manuals, and imaging CRFs

Los Angeles, CA

Senior Medical Writer

Los Angeles, CA

Abernathy, Nienow and Zboncak

Los Angeles, CA

Senior Medical Writer

Provide scientific expertise to Business Development in the development of new business pitches and proposals
You will assist Business Development team with the preparation of proposals and cost estimates for medical writing tasks
To assist Senior Management to assess functional operations and plan for new procedures
Communicates with and works effectively and productively with all authors on the development of scientific publications
Ensures publications are developed in accordance with the established timelines
Develop detailed timelines for document development in line with team and company goals and procedures
Assist Business Development with the preparation of proposals and cost estimates for medical writing tasks.

present

Detroit, MI

Principal Medical Writer

Detroit, MI

Bashirian-Block

present

Detroit, MI

Principal Medical Writer

present

Managing the business development and pricing projects for Medical Writing
Serves as medical writing lead on more complex clinical regulatory documents such as those associated with filings and dossiers. Works closely with the Publications or Regulatory team(s) on document strategies. Implements all activities related to the preparation of publications (e.g. abstracts, posters/oral presentations, manuscripts) or to the preparation and compilation of data and information into a single comprehensive package for new and updated clinicals
Serves as a subject matter expert within department for assigned therapeutic/product areas. As assigned, provides direction and guidance to medical writers regarding assigned projects, including review of work product. Provides input and feedback to management regarding internal medical writers' work product/quality. Recognizes potential scheduling and resource conflicts for projects across therapeutic area/product assignments and provides recommendations to resolve
Serves as medical writing lead on more complex or clinical regulatory documents such as those associated with filings and dossiers. Works closely with the Publications or Regulatory team(s) on document strategies. Implements all activities related to the preparation of (e.g. abstracts, posters/oral presentations, manuscripts) or to the preparation and compilation of data and information into a single comprehensive package for new and updated clinicals
Serves as a department representative on project teams. Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments (e.g. eDocs, eCTD, journal/congress databases). Coaches, mentors, and assists medical writers. Provides guidance to non-Abbott medical writers and external vendors/agencies. Recommends, leads, and implements tactical process improvements, both within the department and division-wide
Manage the review and approval process of clinical submissions documents, writing documents, generating consensus among reviewers, and facilitating discussions. Provide process, content, and submission document planning to the Clinical Submission, Clinical Satellite and Clinical Trial Teams. Advising on resource utilisation, efficiencies and timelines
Assisting business development in securing new business

Education Education

Bachelor’s Degree in Life Sciences

University of Washington

Bachelor’s Degree in Life Sciences

Skills Skills

Good computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
Able to quickly acquire working knowledge regarding a variety of scientific/medical fields
Basic knowledge of statistics, basic data interpretation and presentation skills
Detail-oriented. Methodical. Goal-driven. Good judgment. Able to work with minimal supervision
Good knowledge of regulatory documentation and drug development process
Good interpersonal skills. Ability to work within a team
Knowledge of medical terminology and basic statistical/clinical concepts
Competence in completing good first draft technical reports or clinical reports within a reasonable timeframe with limited guidance
Strong interpersonal skills and the ability to be flexible in varying environments and with multiple customer groups
Cognitive abilities including; verbal reasoning, attention to detail, critical thinking, and analytical ability

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Medical Writer Resume Examples & Samples

Have an eye for detail and be able to proofread and perform copy editing
0-3 years experience
Masters in a scientific discipline preferred but can be substituted for experience related to scientific/medical writing

Medical Writer Resume Examples & Samples

BS degree in pharmacy or Doctoral level degree in a biomedical field 2 years experience in searching the biomedical literature 2 years experience in interpreting and using medical communication documents
Knowledge of biomedical and pharmaceutical databases and vendors for accessing them
Knowledge of Boolean logic/operators
Knowledge of medical terminology and basic statistical/clinical concepts
Problem-solving capabilities and excellent organizational skills
Excellent grammatical and communication skills
Writer skills, i.e. command of outlining, drafting, revising, and reviewing
Basic editorial and proofreading skills
Methodical
Goal-driven
Good judgment
Able to work with minimal supervision
Adaptable and flexible in nature
Ability to work within a tea

Lead Medical Writer Resume Examples & Samples

85% - Leading the MW activities for assigned project(s) including writing key deliverables
15% - Leading or participating on non-project related initiatives
Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelor’s degree required
5-7 years experience in clinical/pharmaceutical development with directly related medical writing experience
Global regulatory submission experience preferred
Ability to understand and interpret clinical and scientific data with minimal oversight; ability to define data presentation to meet key messages developed by the clinical team
Ability, with some oversight, to lead the development, review, and approval of all clinical document types (ie, those typically developed by MW)
Basic project management skills including understanding of clinical timelines (study and submission level) and working knowledge of roles of other functional areas and the interdependencies among groups
Ability to manage work timelines within assigned program(s)
Strong written presentation skills and ability to present information to others
Effective oral presentation skills (ie, ability to effectively lead a meeting and present issues)
Ability to interact effectively with team members/leaders
Ability to assess issues and develop potential solutions
Working knowledge of current global regulatory requirements/guidelines applicable to clinical research (eg, GCP)
Working knowledge of the regulatory guidances regarding content for various document types including, but not limited to, ICH E3 (CSRs), ICH E6 (IBs), ICH M4, ICH E2E, EMA guidance on RMPs)
Strong knowledge of MS Word (required), Excel (preferred), Project (preferred), Powerpoint (preferred), and Outlook
Working knowledge using an electronic document management system; ability to use document templates; ability to work with multiple document template styles and types

Senior Medical Writer Resume Examples & Samples

Requires a Bachelors/Masters degree in a scientific discipline or equivalent with a minimum of 2 to 5 years experience with a Bachelors, or 0 to 2 years with a Masters and demonstrated working knowledge of scientific principles
Minimum 2 year experience in medical writing (3+ preferred) and publication strategy experience preferred
Strong background in the basic sciences, with minimum 2-3 years experience in biotech/pharmaceutical
Strong interpersonal, influence management, communication and organization skills
Project management understanding, including decision analytical skills, budgeting and resource allocation and utilization
Experience with information gathering and collection for research background
Solid understanding of publication development activities, including gap analysis, planning and development strategies and tactics a plus

Senior Medical Writer Resume Examples & Samples

With minimal support, write, edit, or otherwise facilitate completion of clinical documents, including clinical study reports, investigators’ brochures, subject narratives, Module 2 summary documents, and other IND/CTA or global regulatory submission documents
Actively support and participate in clinical project team(s) as as an effective representative of Medical Writing
Manage writing, editing, QC and publishing activities for assigned projects
Review, edit, and ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards
Ensure that medical writing activities are coordinated between the project team and management of the medical writing group
At least 5 years of pharmaceutical industry experience in the clinical/regulatory field
Global regulatory submission experience
Ability to interact effectively with team leaders/members and be able to proactively facilitate effective information exchange/communication (including problem solving and issue resolution)
Knowledge of current regulatory requirements and guidelines applicable to clinical research and GCP/ICH/eCTD compliant documents
Working knowledge of template use for document creation
Ability to work with different template styles and types

Medical Writer, Phase, Remote Position Resume Examples & Samples

Bachelor’s degree in a scientific discipline or licensed certification as an RN with 2+ years of experience
Working knowledge of biomedical and statistical concepts
Proficiency in Microsoft Office Suite

Medical Writer Contractor Resume Examples & Samples

2+ years of industry experience with a Masters' Degree in a Science discipline or 1+ year of industry experience with a Ph.D, Pharm.D, or equivalent in a Scientific discipline
Previous training in the Biomedical Sciences, particularly in areas such as: Biology, Pharmacology, Chemistry and Biotechnology
Solid understanding of Medical terminology

Senior / Lead Medical Writer Resume Examples & Samples

6+ years experience in the medical/regulatory writing field in the pharmaceutical/biotech industry or CRO environment
Proficiency at authoring/editing CSRs, experience authoring/editing multiple other types of clinical regulatory documents (eg, study level, program level, health authority responses), and knowledge of multiple therapeutic areas, disease areas, and technical disciplines
Thorough knowledge of the drug development process with an understanding of the strategy for regulatory submissions
Knowledge and understanding of the principles of GXP, ICH, CTD and other global standards
Requires an advanced degree in a scientific discipline or a bachelor's degree with equivalent work experience

Medical Writer Resume Examples & Samples

Project work
Financial
Monitor own adherence to budget and utilization rate
Organizational
Support team working principles within the business unit, account team and other departments and collaboration between business units by attending team and editorial meetings/tutorials

Senior Medical Writer Resume Examples & Samples

Write and manage delivery of scientific content for a range of medical communications that meet client needs, internal quality standards and timelines
Act as Lead Writer for one or more major accounts and provide the main point of contact on matters of scientific content for the client and KOLs
Provide editorial quotes for costing purposes
Advise Assistant Scientific Services Director and Scientific Services Director about resource requirements
Recommend authors, publications and target journals
Address journal peer review comments
To review scientific content for range of medical communications, according to client needs, internal quality standards and agreed specifications, budgets and timeframes
Monitor quality, style and accuracy and provide timely, consistent and constructive feedback
Ensure that projects reflect a thorough understanding of clients’ objectives Maintain broad awareness of developments in relevant therapeutic areas and discipline, editorial issues within publishing and the Springer Healthcare product portfolio
Contribute to revenue targets by ensuring that projects are progressed as soon as possible after confirmation
Record and monitor actual time spent on a project against budgeted time, and complete timesheets in an accurate and timely manner
Apply knowledge of the therapeutic use and strategic marketing of pharmaceuticals to account plans, strategic publication plans, strategic communication programs, proposals and pitches
Participate fully in briefing and brainstorming meetings
Provide scientific expertise to Business Development in the development of new business pitches and proposals
In conjunction with the Scientific Services Director and Assistant Scientific Services Director(s), help develop writers within an account team to achieve their full potential
Coach and mentor junior writers as required
Assist the Scientific Services Team Leader and Scientific Services Director in preparing and updating SOPs/training modules and in delivering editorial training in relevant therapy area/discipline
Contribute to or conduct (as appropriate) performance and learning & development reviews and develop and monitor progress of objectives with direct reports
Assist the Scientific Services Team Leader and Scientific Services Director in recruitment by interviewing candidates if required
Support team working principles within Medical Communications, account team and other departments and collaboration between business units by attending team and editorial meetings/tutorials
An excellent understanding of the pharmaceutical industry and the drug development process
Experience in data handling and analysis
Excellent writing, editing, and organizational skills
Proficiency with Word, PowerPoint and other Microsoft packages
Ability to manage multiple writing projects at one time
Ability to present clearly and confidently to the highest level of customer

Medical Writer Resume Examples & Samples

5+ years of experience as Medical Writer
Experience with preparation of clinical documents (e.g. Clinical Trial Reports (Phase I - IV) and associated appendices, Investigator's Brochures, clinical sections of IND/IMPD/NDA/MAA/CTD
Experience with preparation of Periodic Safety Update Reports, Annual Safety Reports, Ad Hoc Safety Reports, Clinical Expert Statements, Risk Management Plan)
Working knowledge of regulatory guidance (such as ICH guidelines, EMEA requirements and FDA guidelines)
Proficiency in using Documentum or other document management systems

Medical Writer Resume Examples & Samples

PhD in Science or Master's in Science depending on experience
Experience with Common Computer Software
2-3 years of experience as a Medical Writer

Medical Writer Resume Examples & Samples

Resolve content-related queries from the client
Participate in brainstorming new product lines or solutions that meet client needs
Contribute to process improvements related to creation and maintenance of projects
Advise Commercial and Editorial Services Directors about resource requirements
Minimum of 5 years’ writing and editorial experience
Experience in medical communication, tactical medical education, or training required; proven creativity preferred (eg, journalism, writing for a lay audience)
Experience in oncology, endocrinology/diabetes, neurology, and immunology/infectious diseases is an advantage
Superior language and communication skills
Abilitiy to translate complex scientfic materials into various formats efficiently
Customer focus, Teamwork, Innovation, Communication, Business awareness
Ability to work independently with minimal supervision and also collaboratively with a team
Understanding of the healthcare industry

Medical Writer Resume Examples & Samples

3+ years of Medical Writing experience in the Pharmaceutical / Biotechnology industry or CRO environment
Experience or background in working within the Pharmaceutical industry
Awareness of Compliance issues and guidelines around Medical Education and Publications
Strong Medical Writing / Copyediting skills
Microsoft Office / Suite proficient
Advanced Degree in Life or Health Sciences
Knowledge of the Drug Development process
Relevant Therapeutic background
Clinical experience

Medical Writer Resume Examples & Samples

Performs macroediting of documents for organization, content, structure, and tone, and to ensure documents are consistent, and microediting of documents for punctuation, grammar, sentences, paragraphs, and writing styles
Coordinates the review, revision, quality control, quality assurance, electronic publishing, and approval of documents
Performs other projects and duties as required/assigned

Senior Medical Writer Resume Examples & Samples

Advise Associate Scientific Services Director and Scientific Services Director about resource requirements
Review scientific content for range of medical communications, according to client needs, internal quality standards and agreed specifications, budgets and timeframes
Ensure that projects reflect a thorough understanding of clients’ objectives
Maintain broad awareness of developments in relevant therapeutic areas and discipline, editorial issues within publishing and the Springer Healthcare product portfolio
Coach and mentor junior writers as required
Any other duties as requested by manager

Medical Writer Resume Examples & Samples

2+ years of Medical / Managed Markets writing experience
Knowledge and experience with Managed Markets solutions, Healthcare landscape and Payer / Managed Markets terminology
Exceptional creative and writing abilities
Degree in Nursing or PharmD

Senior Medical Writer / Editor Resume Examples & Samples

Develop technical summaries for drugs under investigation (for healthcare professionals and consumers)
Monitor scientific conferences and journals to stay up-to-date on the latest HIV/AIDS information
Write and edit consumer-based content for the AIDSinfo web site, including fact sheets, clinical trial summaries, drug summaries, and other consumer-based materials using highly technical medical references
Use a content management system to post information on the web, and review all postings to assure they match in text, style, and formatting to their original source documents
Maintain and perform quality-control checks on all written materials produced on the project
Upon request, support writing and editing of proposals, contract deliverables, and other business development activities
PharmD or advanced science degree required (e.g., biology, chemistry, biochemistry)
3 years medical writing experience
Ability to read and summarize technial journal articles for a lay audience
Proficiency in searching online scientific databases
Proficiency in MS Office applications (Word, PowerPoint, Outlook, Excel)
Degree in a health or life science (e.g., public health, health communications, nursing, biology, biochemistry)
HIV/AIDS-related experience
Experience writing for government

Medical Writer Resume Examples & Samples

With support from senior level writers and/or Medical Writing Group Lead, write, edit, or otherwise facilitate completion of clinical documents, including clinical study reports, investigators’ brochures, subject narratives, and other IND/CTA or global regulatory submission documents
Complete documents and other assigned tasks within established timelines and with high quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes
Manage writing, editing, QC and publishing activities for assigned projects under the guidance of Medical Writing Group Lead and/or senior level writers
Contribute to statistical output plan concerning organization and table layout for a specific document
Work with Medical Writing Group Lead and/or senior level writers to ensure that medical writing activities are coordinated between the project team and the medical writing group
Advanced degree in a relevant scientific/clinical/regulatory field preferred
At least 2 years of pharmaceutical industry or academic experience in the clinical/regulatory field preferred
Ability to understand and interpret clinical and scientific data; ability to define data presentation to meet key messages constructed by the clinical team
Ability to adhere to regulatory requirements and guidelines applicable to clinical research and GCP/ICH/eCTD compliant documents
Strong knowledge of MS Word, Excel, MS Project, PowerPoint, and Outlook
Ability to prioritize multiple projects

Medical Writer, Research Consultant Resume Examples & Samples

Advanced degree in Science or English
Exposure to healthcare data
Background in scientific research

Senior Medical Writer Resume Examples & Samples

To provide strategic direction and manage tactical delivery of scientific content for a range of medical communications that meet client needs, internal quality standards and timelines
Act as senior editorial lead for one or more accounts and provide the main point of contact on matters of scientific content for the client and KOLs
Advise Senior and Scientific Services Directors about editorial resource requirements
To review scientific content for a range of medical communications according to client needs, internal quality standards and agreed specifications, budgets and timeframes
Provide full briefs to delegate editorial projects to Medical Writers and Associate Medical Writers to include scope, content, time to spend on project and deadlines
Monitor quality, style and accuracy and provide timely, consistent and constructive feedback when reviewing
Ensure that projects reflect a thorough understanding of clients’ marketing objectives and that scientific messages are supported appropriately
Liaise with clients and Account Manager to agree specifications and check that client expectations are being met
Liaise with Senior and Scientific Services Directors on junior writers’ training needs and provide coaching and mentoring as required
Provide scientific expertise to Business Development Manager in the development of new business pitches and proposals
Provide scientific input to complement Account Management in developing new opportunities within accounts
Assist with delivering editorial training in relevant therapy area/discipline
Assist Senior and Scientific Services Directors in review of test projects and/or recruitment by interviewing candidates, if required
Support team working principles and collaboration within inScience Communications, the account team and other departments, by attending team and editorial meetings/tutorials

Senior Medical Writer Resume Examples & Samples

Required: Master's degree in Biological Sciences or Medical Writing or equivalent interdisciplinary program
Preferred: PhD Degree in Biological Sciences or equivalent interdisciplinary program
Required: Five years of related experience in medical writing
Preferred: Five years of related experience in medical research environment

Medical Writer Resume Examples & Samples

Having a thorough understanding of the biology of chronic kidney disease, therapeutics, and competitive scientific data
Preparing or editing documents for submission to external clients
Preparing or editing internal documents requiring robust scientific summaries
Performing QC checks on documents
Conducting literature searches, reviewing pertinent literature, and preparing summaries or abstracts, as required
Supporting DCR activities at scientific congresses
Preparing and delivering scientific presentations to project stakeholders and key opinion leaders
Here is what you can expect when you join our Village
Award-winning education and training across multiple career paths to help you reach your potential
A comprehensive benefits package designed to enhance your health, your financial well-being, and your future
Advanced degree in the life sciences or a related medical/scientific field with at least 2 years medical communications and/or postdoctoral experience
Knowledge of publication guidelines and best practices
Experience analyzing and communicating scientific data in peer-reviewed journal publications and in abstracts and presentations at scientific congresses
Solid skills in critically appraising scientific literature and conducting comprehensive searches
Experience working independently with minimal supervision; ability to work remotely in a matrix environment
Knowledge of pertinent software (eg, MS Office, EndNote, Adobe Illustrator, GraphPad Prism)
Preferred Qualifications
Previous medical communications experience in a biotechnology or pharmaceutical company
Previous relevant nephrology experience
Successful track record in publication planning and execution
Superb written and verbal communication skills; experience in both scientific and business presentations and communications
Ability to apply project management skills to advance multiple projects simultaneously
Sound working knowledge of ethical, legal, and regulatory guidelines and requirements applicable to medical and scientific affairs activities

Medical Writer Resume Examples & Samples

Advanced Scientific Degree (MSc., Ph.D., Pharm. D) required. Bachelor's Degree will be considered with appropriate work experience
5+ years of medical writing experience in a pharmaceutical/biotechnology or CRO environment
Responsible for writing and editing documents including, but not limited to, investigator brochures, integrated clinical/statistical study reports, clinical protocols and amendments, Integrated Summaries of Safety (ISS) and Efficacy (ISE), annual reports/DSURs, manuscripts and posters
Accurately and consistently presents key clinical messages in accordance with program goals and regulatory requirements
Writes documents (both internal and external) to ensure the timely delivery of high quality documents that are scientifically rigorous, logically organized, and provide accurate data presentation and interpretation
Ensures final document adheres to standard operating procedures (SOP), good clinical practice (GCP), and the international conference on harmonization (ICH)
Assists in developing strategy for organizing and preparing clinical documents for regulatory health authority submissions
Performs quality control review of medical writing documents
Assists in the development of templates, style guidelines and SOPs for clinical documentation

Medical Writer Resume Examples & Samples

Current working knowledge of the Department of Health and Human Services (DHHS) regulations, International Conference on Harmonization/Good Clinical Practices (ICH/GCP), Food and Drug Administration (FDA), and Office of Human Research Protections guidelines
Ability to write and edit clear, concise clinical documents compliant with FDA and ICH guidelines, as well as all practices and procedures related to medical writing
Ability to write concise meeting summaries and/or meeting minutes and create action plans
Ability to prioritize workload and submit high quality deliverables in a professional environment under tight deadlines
Strong collaborative skills with ability to build relationships within multiple groups
Must be detail-oriented and possess substantial organizational skills

Medical Writer Resume Examples & Samples

Produce high quality and timely communication materials (manuscripts, reports, abstracts)
Must be able to work smoothly as an integrated component of various case teams and be able to manage multiple projects simultaneously
Effectively edit, proofread, and format all client messaging deliverables as well as occasional internal documents such as training manuals
Handle all aspects of submission and follow up with journal editors; manage projects to ensure that authors respect deadlines and respond to comments promptly and effectively
Review, critique, and revise written summaries of analytical work prepared by consultant case teams
Contribute a reader's perspective and constructive criticism to analytical team to optimize the quality of the written messaging
Participate in the development of standard approaches to manuscript writing and content development
Act as a resource to colleagues to help them improve their writing and data presentation skills in the development of tables, graphs and other material ultimately incorporated client messaging documents
Excellent writing abilities. Must be able to write clearly and concisely, and to explain complex scientific information to the general public, as well as to scientific peers
Familiarity with scientific manuscript writing and format. Must be able to understand and quickly synthesize economic and clinical information
Familiarity with medical terminology and clinical trial design (theoretical knowledge is sufficient). Must be able to rapidly research various health-related research areas, absorb, and synthesize the information in short time frames
Familiarity with some reference manager software (EndNote, Reference Manager, Mendeley, Citavi, etc.). Must be able to produce fully referenced content and to adapt easily to new technologies and methodologies
Extensive experience with standard MS Office Suite software, including Word, PowerPoint and Excel. Advanced document design skills (e.g., style, page, and document design) preferred
Excellent time and project management skills, as well as team working skills. Must be able to prioritize and meet overlapping deadlines, take ownership of task schedules, as well as work well with multiple teams on separate projects

Medical Writer Resume Examples & Samples

Work with investigators within the Department of Medicine to develop, write, and revise basic, translational, and clinical research grant proposals for NIH, foundations, and other appropriate funding agencies
Provide constructive feedback to investigators to improve clarity, logic, and persuasiveness of grant proposals
Advise investigators on best strategies to convey significance, impact, and innovation of their research plan
Consult with investigators in responding to critiques for grant proposal resubmissions
Work with investigators to develop other scientific and/or medical documentation, as appropriate
Establish and maintain effective working relationships with investigators
Assist with other duties associated with the Department of Medicine Research Office, as appropriate
Excellent critical analysis skills
Able to quickly acquire working knowledge regarding a variety of scientific/medical fields
Able to establish effective collaborations with faculty investigators in various disciplines
Able to meet deadlines in a timely manner
Able to organize multiple tasks with varying deadlines
Experience in an institution of higher education or large hospital
Experience working as an independent consultant or medical writer
Experience with submission of both small and large NIH grant proposals, preferably in an institution of higher education

Technical / Medical Writer Resume Examples & Samples

Work cross functionally with subject matter experts to create and review all documents authored within the R&D department
Ensure high writing quality, readability and consistency across all documentation
Create and enhance processes for: document preparation, training for document authors and document approvers, and measurement of performance of writing activities (cost of documents, timeliness of documents, quality of documents)
Understand business objectives and prioritize work accordingly
Support a culture of continuous process improvement
Mentor staff and display a strong commitment to coaching and development to contribute to career development within the department
Develop and maintain strong ties with all functional groups and geographic locations within the business unit
Bachelor’s degree with 9+ years exp. OR Master’s degree with 7+ years exp. in life sciences, or related field; higher degree preferred
5+ years’ experience in technical writing in a regulated commercial setting (CRO/biotech industry), preferably medical devices/ IVD diagnostics
Excellent knowledge of Microsoft Word and Excel
Experience with document control process preferred
Excellent writing, editing, organizational, teamwork, and verbal communication, and leadership skills are essential
Experience and knowledge of documents pertaining to medical devices /molecular diagnostics assay development & statistical methods is required

Expert Medical Writer Resume Examples & Samples

Participate in planning of analysis and data presentation for individual study reports or summary documents
Act as project medical writer for complex submission programs
Contribute to development of document templates and processes both within
Excellent medical writing skills
Expert data interpretation and presentation skills
Good understanding of statistics
Expert knowledge of regulatory requirements and clinical development
Good leadership skills within cross-functional teams
Good influencing and negotiating skills
Ability to mentor other medical writers
Experience of process improvement initiatives

Senior Medical Writer Resume Examples & Samples

At least 3 years medical writing experience
Good knowledge of statistics and data interpretation and presentation skills
Very good knowledge of clinical documentation
Good knowledge of regulatory requirements
Good knowledge of drug development

Medical Writer Resume Examples & Samples

Writes and edits clinical documents sent for regulatory review or approval including: clinical plans, clinical study protocols and reports, integrated summaries, package insert text relating to clinical studies, responses to FDA and regulatory agency inquiries
Provides significant scientific contribution in preparation of clinical documentation
Represents medical writing in clinical project teams and/or core team meetings
Develops and manages timelines for document development
Supports clinical communication efforts including presentations, abstracts, manuscripts or ad hoc reports
Researches and reviews medical and scientific literature
Contributes in the development of clinical plans with the appropriate hypotheses, study designs, and methods
Works with team members to ensure scientific integrity of data by assisting in the development of data collection/review/analysis materials (e.g., CRFs, statistical analysis plans)
Provides scientific guidance to team members and reviews data to identify and investigate discrepant results or issues
Integrates various sources of information into uniform language styles and analyzes documents for accuracy, consistency, relevancy, correctness of conclusions, alternate hypotheses, editorial corrections, and other issues for regulatory compliance
Collates multiple reviewers’ comments, analyzes applicability, and edits documents to reviewers’ satisfaction
Provides drafting and editing support as needed for protocol amendments, and continuing reviews
Keeps abreast with current industry practices and regulatory requirements and guidelines pertaining to medical writing
Produces high quality documents in accordance to regulatory standards, including but not limited to FDA and ICH guidelines, and GCP’s, as well as company SOP’s and templates
BA or BS in Life Sciences with at least 9 years of medical writing experience, or MS degree with at least 6 years of medical writing experience, or PhD. with at least 4 years of medical writing experience
Molecular diagnostics industry experience strongly preferred
Scientific and clinical expertise strongly preferred
Advanced scientific reading, writing, and editing skills
Good understanding of clinical experimental methods, clinical study design, and statistical analysis
Ability to interpret, analyze, and report statistical data from clinical studies to meet regulatory obligations, and for scientific publication or presentation
Expertise in searching medical literature and databases for clinical and technical information
Solid understanding of FDA regulations and ICH/GCP guidelines
Excellent project/time management and organizational skills to handle multiple tasks and meet deadlines while delivering high quality work
Ability to accurately interpret data and present complex information in a clear and concise written manner
Proficient computer and word processing skills

Senior Medical Writer Resume Examples & Samples

Bachelor’s degree/Nursing Degree required. Masters or PH.D preferred
Bachelor’s degree plus 8 years relevant experience; or Masters degree plus 6 years relevant experience or PhD plus 2 years relevant experience
Experience in the conduct of clinical research/medical communications required. Technical writing experience required
Writing experience in medicine, science, business, and technology required
Experience from a contract research organization, pharmaceutical or biotechnology firm preferred
Must have in-depth knowledge of the research and writing process, FDA guidelines, regulatory guidelines, AMA style guidelines and other specialized medical writing knowledge
Experience in medical writing of regulatory documents such as patient narratives, informed consent forms, experience papers, manuscripts preferred
Must possess excellent interpersonal, written and oral communication skills, with demonstrated ability to communicate scientific information inside and outside the organization

Senior Prin Medical Writer Resume Examples & Samples

Bachelors Degree with 10+ years of experience supporting clinical research. Clinical research includes: industry sponsored clinical research, physician sponsored clinical research, or government sponsored clinical research. Similar medical/scientific experience (e.g. has written and implemented protocols for experiments or animal research, has a good understanding of the research process) may be acceptable
MS, MA, or MPH with 8+ years of experience or PharmD, PhD, DVM, or MD with 6+ years of experience
BS or BA with 10+ years of experience supporting clinical research. Clinical research includes: industry sponsored clinical research, physician sponsored clinical research, and government sponsored clinical research or any other clinical research that would lead toward regulatory submission, review and approval for market clearance. Similar medical/scientific experience (e.g. has written and implemented protocols for experiments or animal research, has a good understanding of the research process) may be acceptable
MS, MA, or MPH with 8+ years of experience or PharmD, PhD, DVM, or MD with 6+ years of experience supporting clinical research
At least two years of study management experience preferred
Experience in assessing medical evidence
Experience in publication planning
Project management skills and experience with related tools (Microsoft Project)
Familiarity with ICMJE guidelines and Good Publication Practices
Demonstrated ability to identify issues and implement solutions, including identifying and involving the appropriate decision makers
Demonstrated ability to motivate and hold individuals accountable to deliverables; ability to achieve objectives and milestones
Working experience with clinical and outcomes research study design, Good Clinical Practices, and global clinical regulations, including FDA regulations and ICH guidelines, for devices, biologics, and/or pharmaceuticals

Prin Medical Writer Resume Examples & Samples

Bachelors Degree with 7+ years of experience supporting clinical research (MS, MA, or MPH with 5+ years of experience or PharmD, PhD, DVM, or MD with 3+ years of experience). Clinical research includes: industry sponsored clinical research, physician sponsored clinical research, or government sponsored clinical research. Similar medical/scientific experience (e.g. has written and implemented protocols for experiments or animal research, has a good understanding of the research process) may be acceptable
Experience in technical writing such as clinical study plans, clinical reports, scientific manuscripts, clinical evidence reports
Demonstrated ability to identify and adapt to shifting priorities and competing demands, and maintain composure in difficult circumstances
Willingness to accept challenging assignments and engage in relevant developmental activities
Proficient knowledge of medical terminology
Knowledge in the areas of neurology and/or psychiatry
Demonstrated ability to cultivate relationships with co-workers in a cross-functional environment

Prin Medical Writer / Clinical Evidence Spec Resume Examples & Samples

Strong critical thinking and analytical skills
Ability to provide performance feedback and ability to appropriately respond to feedback from customers and coworkers
Demonstrated ability to clearly and effectively communicate verbally and in writing

Senior Prin Medical Writer Resume Examples & Samples

6+ years experience supporting industry-sponsored clinical research
2+yearssupporting medical/scientific publications
Expert in scientific communication and writing skills
Ability to interpret clinical data and understand biostatistics
Expertise using EndNote, PowerPoint, WORD and Excel
Strong knowledge of medical terminology and literature searching
Significant work experience in publication development in the biotechnology industry or a specialty vendor. Specific experience with publications in cardiovascular disease and treatment
Demonstrated ability to successfully interact with a variety of functions and levels within an organization

Principal Medical Writer Resume Examples & Samples

Implements all activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (US and ex-US)
Coordinates the review, approval, and other appropriate functions involved in the production of clinical regulatory projects
Serves as a department representative on project teams
Communicates deliverables needed, writing process, and timelines to team members
Converts relevant data and information into a form that meets clinical regulatory document requirements
Ensures all clinical regulatory electronic document deliverables are processed and compiled in alignment with timelines
Assesses resource needs as timelines progress, and communicates those needs to department management
Understands, assimilates, and productively interprets sources of information, with appropriate guidance/direction from product teams and/or authors. Ensures required documentation is obtained
Interprets and explains data generated from a variety of sources, including internal and external studies, research documentation, charts, graphs, and tables
Explains data in manner consistent with clinical regulatory requirements
Confirms completeness of information to be presented. Challenges conclusions when necessary
Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies by following applicable divisional guidelines, templates, and SOPs
Arranges and conducts review meetings with the team
Independently resolves document content issues and questions arising during the writing process
Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments
Maintains expert knowledge of US and international regulations, requirements and guidance associated with clinical regulatory document preparation and submissions
Recommends, leads, and implements tactical process improvements
Serves as medical writing lead on more complex clinical regulatory documents such as those associated with filings and dossiers. Works closely with Regulatory on document strategies

Contract Medical Writer Resume Examples & Samples

Oversee number accuracy against source documents and for consistency within given document and between associated documents (for example, making sure the details of a protocol align with the SAP and IB, or making sure the messaging and details in a briefing package align with the messaging and details in applicable protocols, study reports, IBs, other regulatory submission documents, etc.) per MW SOPs and internal procedures
Familiarity with ICH, GCP guidelines and associated clinical development regulations such as the eCTD and submission readiness is required
Expertise with Word and Adobe Acrobat is a must
The successful candidate will be focused, methodical, and detail oriented, able to discriminate substantive or critical errors from minor ones, and will be able to communicate diplomatically and function as a collaborative team member

Medical Writer Resume Examples & Samples

Bachelor’s Degree in health science or other area; advanced degree preferred
Nursing, pharmacy, or other clinical experience is preferred
Experience with regulatory submissions presented to regulatory authorities
1-3 years of directly related work experience as a medical writer in a clinical research of drug development environment (pharmaceutical/biotech or CRO setting)
Must be familiar with Common Technical Document (CTD) standards, and have experience working with standard document templates/styles to support electronic (eCTD) submissions
Must be comfortable working in a demanding, fast-paced environment
Must be comfortable responding to and managing change
Must be proficient with Windows, Microsoft Word, Microsoft Excel, Adobe Acrobat, and Microsoft PowerPoint
Must have excellent written and oral communication skills, keen attention to detail
Must have the ability to manage day to day tasks while understanding and appreciating the overall strategic goals for the team/department/project/company

Senior Medical Writer Resume Examples & Samples

Responsibilities may include but are not limited to
In collaboration with other functional areas, contribute to regulatory submissions by authoring relevant sections of eCTDs (e.g., ISS, Summary of Clinical Safety)
Analyze, interpret, and accurately present data in text, table, or figure format, as needed
Assisting with responses to questions from regulatory authorities (e.g., MA and FDA)
Reliance on instructions, templates, and pre-established guidelines will be expected to perform the above functions. The candidate must be able to work independently and efficiently with cross‑functional team members
The ideal applicant would have training in the biomedical research sciences, particularly in areas such as biology, pharmacology, chemistry, and biotechnology
The applicant would have previous experience leading and writing submission-level documents, including familiarity with eCTD format and associated guidance’s
This position requires translating technical information from multiple sources (Statistical Analysis Plans, previous regulatory submissions, programmed data outputs) into summary documents suitable for an audience of regulatory authorities
As a lead author, this person must work cross-functionally with appropriate teammates to create, coordinate review of, and edit through finalization required regulatory clinical summary documents
The exercise of good judgment in the incorporation of review comments from multiple individuals will be needed
The applicant must be able to prepare deliverables in accordance with pre-established timelines and specifications, systematically performing activities in a timely and accurate manner
A commitment to accuracy of data presentation and ever improving the clarity of communication is essential
This writer will also engage in the project management of document support activities by others (QC and publishing) to deliver high-quality submission-ready documents in accordance with the agreed timelines
Advanced writing competency, positive and proactive communication skills, proficiency with Microsoft Office Suite, and high attention to detail are expected

Director, Medical Writer Resume Examples & Samples

Experience in multiple therapeutic areas, with prior experience in CNS preferred
Experience in clinical study design and protocol development/writing
Strong interpersonal, communication, and organizational skills; ability to work cross-functionally, collaborate, negotiate with and influence stakeholders at all levels of the organization
Knowledge of regulatory guidelines related to clinical development and regulatory marketing applications
Demonstrated project leadership/management skills
Experience using computerized systems (PC-Windows and MS Word)

Medical Writer Resume Examples & Samples

Creating, modifying and finalizing Site Manuals or Imaging Guidelines, associated fillable forms, quick reference guides and labels
Creating, modifying and finalizing Image Quality Assessment/Photograph Quality Assessment (IQA/PQA) Summaries
Creating, modifying, and finalizing Key Points Documents (KPDs) from CRs
Creating, reviewing, modifying and finalizing MedComm Meeting Minutes
Attending internal and external meetings relating to the Site Manuals, IQA/PQA Summaries, CRs/KPDs
Running Scheduled Tasks for generating MedComm webpages
Checking MedComm webpages for errors
Performing Project Close-outs as they occur based on receipt of Study Closure forms
Reviewing and updating Charter Training Slides as needed
Documenting study-specific Protocol Training (Kick-off Meeting Slides, Protocol Overview Presentations, etc.) by filling out and collecting signatures on group training forms as required
Creating, modifying and finalizing Charters with Key Points Appendix (KPA), Process Documents, Procedures Documents, Methodology Reports, or other read-related study documents
Creating, modifying and finalizing Clinical Data Transfer Plans (CDTPs)
Creating, modifying and finalizing Read Rules documents
Reviewing and modifying criteria-related Investigator Meeting slides
Attending internal and external meetings relating to the Charter, CDTP, Read Rules, or required CRs
Creating, modifying and finalizing Global Conventions and Glossary documents
Reviewing applicable study start-up documents (i.e., Manuals and forms, KPDs if applicable) for accuracy, completion and consistency across all study documents
Staying up-to-date on response criteria publications posted by Medical Communications
Attending and participating in applicable company-sponsored training
Ability to work in a group setting and independently; ability to adjust to changing priorities
Excellent attention to detail and orientation toward meticulous work
Ability to project and maintain a professional and positive attitude
Organization and time management skills for managing multiple projects concurrentl
1+ years medical writing experience required

Principal Medical Writer Resume Examples & Samples

In collaboration with other relevant line functions, prepare and give directions – as medical writing lead –
Provide direction to team on document content and provide innovative solutions to cross-functional areas
Identify resource issues and determine how to allocate resources to meet timelines
In collaboration with medical writing and other functions, prepare internal guidelines for document
Extensive experience writing all types of clinical & regulatory documents and with registration dossiers

Principal Medical Writer Resume Examples & Samples

Assist in the preparation of regulatory submissions (BLAs), scientific manuscripts, abstracts, PowerPoint presentations, and posters as needed
Assist in the development of SOPs for Clinical writing processes
Provide additional support to the Medical Writing team and the Clinical team as needed
Bachelor’s degree in a scientific discipline with at least 8 years of medical writing experience is required; an advance degree is preferred; equivalent combination of education and experience may be considered
Excellent verbal and written communication skills, attention to detail, and project management skills
Knowledge of regulatory guidelines (ICH/GCP) and understanding/compliance with appropriate conventions, proper grammar usage, and format requirements for regulatory documents and publications
Demonstrated ability to work both independently and in team environments
Attention to detail with an ability to detect errors and inconsistencies in various types of documents
Oncology and Biopharmaceutical industry experience is strongly preferred
Clinical research background or experience is preferred
This is an office-based position; proven ability and experience working in-house is critical

Senior Medical Writer Resume Examples & Samples

You will provide additional writing and editing services as required (e.g. for publications) as well as producing preclinical summaries, clinical summaries, pharmacokinetic reports, safety summaries, literature reviews and other documents needed for regulatory submissions
Involved with quality control (review) of documents, you will interpret and summarise data from biostatistical summary tables and listings accurately, precisely and concisely into narrative text
Liaising with internal groups such as Biostatistics, Data Management etc., you will obtain the necessary information to ensure the timely implementation of activities related to the production of reports
You will interact directly with clients (with support where required) and keep the Senior Director of Medical Writing or designee informed of document status in relation to quality and timelines
You will have a life science degree qualification (preferably at post-graduate level) or equivalent and have knowledge of the clinical trial process, gained preferably from previous experience as a medical writer
A highly organised, self-motivated individual, you are able to plan/prioritise effectively and demonstrate expertise with grammar, syntax and format, with advanced word processing and related computer skills
You are a keen problem-solver with excellent written and oral communication skills. You should also have strong interpersonal skills, which enable you to win the confidence and cooperation of colleagues

Principal Medical Writer Resume Examples & Samples

Preparation of clinical study reports or other regulatory documents supporting ongoing clinical development programs and their supportive appendices (or sections of these) by the incorporation of text, graphs, charts, tables, statistical analyses, etc. in a clear and accurate manner consistent with the target audience and regulatory requirements
Be part of a clinical NDA sub team and provide strategic input into modules 2 and 5 of a NDA
Consolidation and evaluation of teammates’ review comments to determine needed revisions
Reviewing statistical analysis plans and accompanying table and listing shells for the evaluation and presentation of clinical trial data
Quality-checking documents for agreement between in-text information and the source data
Editorial review of documents for grammar, punctuation, and submission-compliant formatting
Provide overall medical writing support for ongoing programs (protocols, IBs, etc)
Registered Nurse, Bachelor's degree or higher in Life Sciences
Training in the biomedical sciences, particularly in areas such as biology, pharmacology, chemistry and biotechnology, as well as experience in technical written communication preferred
BS, or RN with 12 years’ experience, MS with 8-10 years’ experience or Ph.D, Pharm.D, or equivalent with 5 years’ experience in medical writing
Excellent and current knowledge of GCP, ICH and FDA regulations is expected
Recent experience with NDA filing(s)
Experience in diabetes/metabolism is desirable
Advanced writing and speaking competency, positive and proactive communication skills, proficiency with Microsoft Office Suite
Ability to function efficiently and independently in a fast-paced, changing environment with high attention to detail
Prioritize and recognize most important aspects of development process
Self-motivated and willing to accept responsibilities outside of initial job description

Managing Medical Writer Resume Examples & Samples

A minimum of 2 years experience managing people, projects and/or the work of others
Provide leadership of and management for complex documentation projects and project teams of medical writers
Demonstrated experience in process improvement

Medical Writer Resume Examples & Samples

Is recognized as a scientific contributor in preparation of selected regulatory clinical documentation
Demonstrates competence in writing, editing and reviewing of clinical study reports, patient narratives, investigator brochures, and other clinical regulatory documents in line with expectations. Able to interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation
With supervision, manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings. Works collaboratively with colleagues across functions to achieve results. Supports the medical writing team with quality control, redaction, and coordination activities, as needed
May participate in initiatives to improve medical writing processes and standards
A minimum of 1 year of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry
Ability to prepare, with supervision a subset of clinical regulatory documents (e.g., CSR shell or appendices, IB updates, patient narratives) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines
Excellent oral (including presentation) and written communication, and project management skills
Awareness of pharmaceutical industry needs beyond clinical development

Principal Medical Writer Resume Examples & Samples

Applies in-depth knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects. Represents functional area in cross-functional teams (either internally or externally)
Produces high-quality and timely documentation in line with expectations. Interprets and applies knowledge of regulatory/compliance/scientific requirements, using own judgment, prior work experience, and broad appreciation of impact on other disciplines
Leads and manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development (e.g., program level standards), trials (e.g., CSRs), and filings (e.g., clinical modules). Works collaboratively with colleagues across functions to achieve results
Solves complex problems associated with medical writing scope of work, involving ambiguous situations across departments and the need to develop new options to resolve
Ability to prepare, without supervision, core clinical regulatory documents according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines
Excellent oral (including presentation) and written communication, and project management skills. Awareness of pharmaceutical industry needs beyond clinical development

Senior Specialist, Medical Writer Resume Examples & Samples

Works with project teams to prepare clinical and regulatory documents, including protocols, study reports, investigator brochures, INDs/IMPDs, and CTDs according to company and agency guidelines in order to support drug development
Contributes scientific knowledge, analytical skills, and insight to Clinical Scientific Operations, Project Team, and Submission Task Force meetings and to cross-functional working groups as needed to facilitate the preparation of reports, and the production of registration dossiers
Provides leadership in completing major summary submission documents (e.g., pivotal study reports, Clinical Summary of Efficacy, Clinical Summary of Safety, and Clinical Overview) to support high-quality submission dossiers
Mentors more junior medical writers and provides leadership in completion of large writing projects
Bachelors degree with 8-10 years of experience as a medical writer, advanced degree preferred (e.g., Masters or Ph.D. in life sciences)
Experience preparing clinical regulatory submission documents, including CTD Module 2 summaries
Demonstrated leadership, problem-solving ability, to work simultaneously on multiple projects, and the ability to prioritize tasks leading to timely completion of high-quality documents

Medical Writer / Senior Medical Writer Resume Examples & Samples

Develop and manage timelines for document development
This position requires a bachelors degree in a life sciences discipline and a minimum of 2 years biopharmaceutical industry experience
Experience preparing clinical regulatory documents and scientific publications is crucial
Experience with early-stage drug development (phase 1) is desirable

Medical Writer Resume Examples & Samples

Prepare routine clinical regulatory documents, including clinical study protocols, clinical study reports, and investigator’s brochures, and sections of regulatory submissions
Assist with preparing more complex documents
Serve as the lead medical writer for routine clinical studies
Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents and ensure consistency between related documents
Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables
Experience producing high quality scientific/medical documents
Ability to analyze, interpret, and summarize data
Basic understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, regulatory requirements, and medical terminology
Basic project management and organizational skills
Attention to detail related to consistency, grammar, syntax, and scientific accuracy
Basic computer skills related to word processing, templates, table/figure creation, and literature searches
Ph.D. (or equivalent degree) and 0 – 3 years of relevant work experience, or
M.S. (or equivalent degree) and 1 – 4 years of relevant work experience, or
B.S. (or equivalent degree) and 3 – 6 years of relevant work experience

Senior Medical Writer Resume Examples & Samples

Write clinical documents for submission to regulatory authorities, including briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, integrated summaries of safety and efficacy
Serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues
Serve as the Medical Writing representative on assigned project teams
Providing proactive support to Project Leadership for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables
Coordinate production and distribution of draft and final documents to project team and client
Experience in writing multiple clinical study reports, and either CTD documents or study protocols
Preferably experience in a variety of indications, particularly CNS (schizophrenia, depression, Alzheimer’s), renal disease, oncology, dermatology
Experience with a variety of documents (CSRs, IBs, protocol/amendments, briefing books, HA responses, post-submission safety updates, and preferably submissions [clinical CTD modules]
A flexible attitude with respect to work assignments and new learning
Willingness to work in a matrix environment and to value the importance of teamwork
Team leadership skills
Extensive clinical/scientific writing skills

Senior Medical Writer Resume Examples & Samples

Write clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, integrated summaries of safety and efficacy
Act in the capacity of project manager/lead for medical writing projects. This may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management
Serve as the Medical Writing representative on assigned project teams, providing proactive support to Project Leadership for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Identify any potential project challenges to departmental line management and project leader including changes in project plan, timeline or out of scope requests, and suggest possible resolution options
Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review
Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines

Senior Medical Writer Resume Examples & Samples

Write high-quality clinical documents that support FibroGen’s goals and objectives
Understand the key components/messages for regulatory submissions as embodied in FDA and ICH guidelines
Identify the customers for each document, and formulate and convey key messages clearly and concisely for those customers
Keep current with therapeutic area(s) relevant to assigned projects
Use appropriate FibroGen stylistic conventions
Keep up-to-date on the software needed for this position
Mandarin technical writing skills is required
5 – 8 + years of industry experience as a pharmaceutical medical writer; an undergraduate degree in a scientific discipline is preferred; an advanced scientific degree is a plus
Knowledge of, or aptitude for understanding, medicine; familiarity with the drug development process and regulatory documentation
Ability to gather and synthesize large amounts of data
Demonstrated ability to write clear, concise, and effective drug development documents, including the ability to turn data into visuals that convey the key messages and to communicate complex information effectively and accurately
Understanding the role of various documents relevant to drug development in an international environment
Good team player; excellent written and verbal communication skills, and the ability to work well with others
Proven document planning and project management skills
Ability to meet timelines without compromising document quality
Ability to communicate with professionals from many functional disciplines and to work across teams (often remotely)
Ability to ensure consistency within and across documents to avoid confusion
Competency in relevant software applications

Principal Medical Writer Resume Examples & Samples

Bachelor's degree in a clinical science (e.g. pharmacy, medical, nursing) or equivalent; Advanced degree preferred
Previous experience of at least 5 years directly relevant to role and in a work setting (e.g. writing and leading medical affairs and regulatory documents); an academic setting is not equivalent for this position due to the medical affairs, client facing, Project Mgmt, and Business Development skills required
Experience with medical affairs studies such as observational, registries, long-term safety, expanded access, dossiers (GVDs and AMCP), etc. and experience working with medical affairs teams sufficient to be able to verbalize the needs of medical affairs relative to regulatory studies
Strong preference for someone with client facing and business development experience
Experience in managing and directing complex medical writing projects
Experience working in the pharmaceutical, but CRO industry preferred

Principal Medical Writer Resume Examples & Samples

Acting as key client contact
Preparing complex documents and providing review of others work
Advising on technical aspects of document preparation
Managing the business development and pricing projects for Medical Writing
Managing Project budgeting/forecasts
Assisting business development in securing new business
Reviewing revenue budgets and adjusting resources accordingly
LI-MW1

Medical Writer Resume Examples & Samples

Research and develop written materials to the highest scientific and grammatical standards, according to internal/client brief, displaying excellent technical accuracy and attention to detail and the ability to tailor materials appropriately for a range of educational needs and target audiences, with adherence to timelines and budgeted hours
Incorporate internal/client/author comments using a scientifically accurate and balanced approach, and with senior support resolve any conflicts in a professional and compliant manner
Maintain broad awareness of developments in relevant therapeutic areas to ensure scientific and clinical relevance of written materials in specific project activities. Develop understanding of the needs of clients, including the marketing/clinical relevance of key data, and work with account team to offer solutions, as appropriate
Exercise good interpersonal/communication skills for effective and professional liaison with the internal team, clients, healthcare professionals and other key stakeholders. Actively participate in meetings with relevant internal and external stakeholders, and respond effectively to questions relating to allocated areas of responsibility
Contribute to the development of proposals/pitches, offering scientific research expertise, as required
Monitor and manage own projects; anticipating workload issues and working with senior medical team members to deliver to required budget and time specifications
Diligently follow all company standard operating procedures (SOPs)
Strong computer skills, including MS office, Word, PowerPoint, Excel, Outlook and Internet
Experience with research tools and approaches, such as reference management/publication planning databases. Good research skills and ability to interpret scientific and clinical data
Strong, versatile medical writing skills
Ability to generate grammatically correct, consistent, scientifically accurate copy, using appropriate writing styles for different audiences
Ability to perform multiple tasks and prioritize work effectively
Ability to be self-directed and manage time efficiently
Familiarity with current industry code of practice guidelines
Budgetary awareness

Medical Writer Resume Examples & Samples

Prepare protocols, clinical study reports, statistical analysis plans, publications, abstracts, posters, slide presentations, and IRB submissions
Create, edit, and maintain procedural documentation including department policies and procedures (SOPs)
Support quality assurance efforts, assemble documentation for audits and ensure that documentation is compliant with federal regulations
Ensure quality of the documents & manage the document review process, including securing buy-in from both internal and external stakeholders
Liaise with client teams to ensure their needs are met

Principal Medical Writer Resume Examples & Samples

Leads a single team which guides medical writing activities within a designated therapeutic area for key response documents and regulatory submissions
Provides more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications
Represents Medical Writing on cross-functional teams and task forces (related to projects, process, and standards)
As required, serves as lead writer for strategic regulatory documents and key components of regulatory submissions
Provides leadership on functional teams that address requirements or issues related to document preparation and production
Bachelor’s degree in science, health profession, or journalism required
Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products
Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs)
Knowledge of team dynamics and ability to function as a team leader

Senior Medical Writer Resume Examples & Samples

Maintain and enhance therapeutic area knowledge including, disease state and compound for assigned project
Maintain and enhance knowledge of regulatory guidelines and publication guidelines
Possess overarching view of compound, therapeutic area, and external environment (including competitors) with ability to lead the scientific data disclosure planning, clinical planning, submission strategy planning, customer regulatory responses, and/or current awareness literature updates and reviews.Provide informal coaching to others by sharing technical information, giving guidance, answering questions
Contribute to process improvements, suggesting opportunities where appropriate
Provide database and other tool (eg, document management systems) expertise.Knowledge Sharing and Consultant Support
Bachelor’s degree in a scientific, health, or technical related field, OR Bachelor’s degree in any field with at least two years of clinical development experience
Strong interpersonal skills and the ability to be flexible in varying environments and with multiple customer groups
Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates)
Graduate degree with formal research component or in life sciences
Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience (e.g., neuroscience, oncology, cardiovascular, or endocrine expertise)
Experience in clinical trial process or regulatory activities
Experience writing regulatory or clinical trial documents
Publication experience
Limited travel, up to approximately 10%

Senior Medical Writer Resume Examples & Samples

Direct and lead the writing, reviewing, editing and approval of clinical documents
Author documents while contributing knowledge of therapeutic areas, clinical drug development, and scientific areas
Provide medical writing and editing expertise for various documents including those for clinical development and medical affairs (clinical study outlines, clinical protocols, amendments, reports, etc.), and for regulatory submission documents (IND applications, NDA, meeting packages, etc.)
Understand and interpret data from a variety of sources and help create figures/tables to effectively communicate clinical study results
Review documents related to clinical study reports, such as Statistical Analysis Plans and tables, figures and listings
Ensure documents are developed according to timelines
Learn and maintain a knowledge of relevant therapeutic areas in order to apply knowledge to various projects
Bachelor’s degree in science with relevant writing experience OR Bachelor’s degree in English or Comunications with significant relevant scientific experience; PhD, PharmD OR Master’s degree highly preferred
Strong organization skills and a high attention to detail
Strong working knowledge of Adobe PDF, MS WORD, EXCEL, PowerPoint, and Project
Experience with automated document templates and AMA style guide
Knowledge of FDA and/or EMEA regulations, GCP, ICH guidelines and familiarity working according to established GCP standard operating procedures

Medical Writer Resume Examples & Samples

Education to Bachelor’s/advanced degree level in a scientific discipline
Prior experience within regulatory medical writing
Excellent grammatical, editorial and proofreading skills
Effective organisational and planning skills
Motivation, initiative and adaptability
Ability to work effectively in a team

Medical Writer Resume Examples & Samples

Providing medical writing support to Clinical Research Associates
Writing protocols for clinical trials
Writing clinical reports for clinical trials
Writing Clinical Evaluation Reports
Writing publication articles such as abstracts and journal publications
Reviewing of medical documents authored by other persons
Completing writing assignments in a timely manner and maintain timelines and workflow for writing assignments
Reviewing of scientific literature
Taking ownership of assignments by proactively consulting other project team members for information and guidance, as necessary
Minimum of three (3) years combined medical and/or technical writing experience
Certification through American Medical Writing Association (AMWA)
Knowledge of Good Clinical Practice (GCP), International Conference on Harmonisation (ICH), and Food and Drug Administration (FDA) guidelines
Direct experience writing Clinical Evaluation Reports
Familiarity with medical terminology
Ability to research and translate large amounts of technical information
Understanding of clinical data
Have expert proficiency with templates and style guide
Demonstrated expertise in computer skills including Microsoft Word and Excel
Persistent and detail-oriented
Excellent ability to multi-task and prioritize
Ability to work effectively on cross-functional teams

Senior Medical Writer Resume Examples & Samples

Preclinical Reports and Summaries
Pharmcokinetic, Pharmacodynamic Studies
Toxicology Analysis
ADME, Including Drug Interactions and Toxicokinetics
INDs, NDAs (FDA)
CTAs
Investigators' Brochures
Protocols
Publications and Literature Reviews
Posting to Clinical Trials Registry
Clinical Safety and Efficacy Reports (all phases)
Prepare documents within the required format of specific stakeholders and/or regulatory agencies
Objective, comprehensive and clear written presentation of scientific and/or clinical data in a format commensurate with ICH and other scientific writing standards. The incumbent must show competence in writing, editing, and reviewing Clinical Study Reports (CSRs) and other clinical regulatory documents
Provide dedicated scientific authoring expertise to both the development and research groups

Senior Medical Writer Resume Examples & Samples

Develop regulatory documents in accordance with applicable guidelines, regulations, practices, and procedures
Ensure accuracy, consistency, and quality of all documents
Represent Medical Writing and provide medical writing expertise on cross-functional and cross-company teams
Develop detailed timelines for document development in line with team and company goals and procedures
Drive documents through multiple rounds of team review to final (ie, distribute documents for review, consolidate and resolve reviewer comments, run efficient roundtables, finalize for publication and signoff) in accordance with established timelines
Collaborate effectively across Ironwood and with Ironwood partner companies and external experts
Support medical writing colleagues as necessary (eg, document review, edit, and QC) and contribute to team excellence
≥ BA/BS and ≥ 5 years’ experience writing a broad range of clinical regulatory documents
Great collaborator with experience working on cross-functional teams
Strong communication, interpersonal, editorial, and organizational skills
Working knowledge of ICH guidelines, GCP, CTD, etc
Proficiency in Microsoft Word (and familiarity with document template use), PowerPoint, and Excel
Ability to manage multiple documents and set clear plans and priorities
Poise under pressure
Scientific background
Knowledge of GPP, ICMJE guidelines, and experience with scientific publications
Experience with clinical trial development

Medical Writer Resume Examples & Samples

Development and updating of Investigator’s Brochures, Safety Update Reports, and other regulatory documents
Preparation of clinical study protocols, clinical study reports or other regulatory documents supporting ongoing clinical development programs. Development of these document’s supportive appendices (or sections of these) by the incorporation of text, graphs, charts, tables, statistical analyses, etc. in a clear and accurate manner consistent with the target audience and regulatory requirements
Quality-checking documents for agreement between in-text information and the source data, and for internal consistency
Provide overall medical writing support for ongoing programs
Reliance on instructions, templates, and pre-established guidelines (eg, Standard Operating Procedures) will be expected to perform the above functions
The candidate must be able to work independently and efficiently with cross functional team members
The ideal applicant would have training in the biomedical sciences, particularly in areas such as biology, pharmacology, chemistry and biotechnology, as well as experience in technical written communication
A good understanding of medical terminology and AMA style is needed
This position requires translating technical information from mixed sources into written information suitable for an audience of regulatory authorities and clinicians. It will be essential to approach issues from a number of perspectives, summarizing data to draw a conclusion
The applicant would have previous experience in leading the writing of clinical/regulatory documents, such as protocols, investigator brochures, annual safety updates, and clinical study reports. as a lead author, this person must work cross-functionally with appropriate teammates to create documents, coordinate their review, and edit through finalization
Applicant must be able to prepare deliverables in accordance with pre-established timelines, systematically performing activities in a timely and accurate manner
Advanced writing competency, positive and proactive communication skills, and high proficiency with Microsoft Office Suite and Adobe Acrobat are needed

Medical Writer / Senior Medical Writer Resume Examples & Samples

Advanced degree with 2+ years relevant writing experience
Must possess the ability to coordinate production of deliverables and provide leadership to a project team
Must possess independence in decision making and problem solving

Senior Medical Writer Resume Examples & Samples

Protocol Development ( and protocol related documents: inform consent form, amendments, study concept sheets, as appropriate)
Lead clinical trial protocol development process with CPO/Region representative (Medical Advisor, statistician, regulatory, etc...) or external authority recommended by customer
Translating the approved trial concept sheets into executable clinical pro-tocol (and Inform Consent Form) ready for customer "Protocol Review Committee" review/approval
Translate study scientific and operational elements into a high quality concept sheet for review and approval by Head Quarters as appropriate
Responsible, with the clinical trial team for preparation of high quality clinical study reports. Participate in planning of analysis, meetings and data presentations to be used in study report
Responsible for clarification of requirements from customer prior to start protocol/concept sheet/ study report development
Incorporate input from authorities (Medical Advisor, Statistician, safety, DRA as appropriate) while ensuring that feasibility at site level, patient safety and trial objective (i.e. publication) are considered when developing the document(s)
Coordination of the protocol, study report versions reviews and approval processes in collaboration with key contributors and customers

Principal Medical Writer Resume Examples & Samples

Write and prepare clinical submissions documents within a team environment
Ensure critical review and interpretation of clinical efficacy and safety data for appropriate medically relevant and Standard Operating Procedure (SOP)/Good Clinical Practice (GCP)/International Conference on Harmonisation (ICH) compliant presentation
Manage the review and approval process of clinical submissions documents; notify team of targeted review responsibilities. Generate consensus among reviewers, resolve conflicting comments, and facilitate discussions in an efficient manner
Coordinate with other Clinical Program Medical Writers and other Medical Writers as needed to maintain consistency across documents within a project and across indications
Maintain and demonstrate expert knowledge of drug development process and applicable regulatory guidelines
Such other responsibilities and projects as the company may assign
6+ years experience in Medical Writing in the Biopharmaceutical industry
An advanced degree (e.g., MS, PhD, etc) may be considered in lieu of years of experience
Ability to work within an international team
Must be detail-oriented, thorough, and methodical
Mastery of the English language, with a comprehensive understanding of English grammar and punctuation
Excellent problem-solving capabilities and organizational skills

Medical Writer Resume Examples & Samples

Degree (minimum BA/BS) in life sciences, clinical sciences, English/journalism, or equivalent related experience
Moderate progressive experience in medical and/or scientific writing preferred or equivalent education and experience
Effective presentation and interpersonal skills; team-oriented
Strong proficiency in Word, Excel, PowerPoint, email, and Internet
Ideally you are already familiar with the principles of clinical research and/ or interpretation, presentation, and proofreading of clinical data or other complex information

Senior Medical Writer Resume Examples & Samples

Demonstrated mastery of verbal and written English skills in the medical, scientific or technical writing fields
Experience writing regulatory, clinical trial documents and or publications
Experience in clinical development, clinical trial process or regulatory activities
Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience specific to hiring area (e.g., neuroscience, oncology, cardiovascular, immunology or endocrine expertise)

Medical Writer Resume Examples & Samples

Exhibit flexibility in moving across therapeutic areas and compounds, depending on project assignment, etc
Provide informal coaching to others by sharing technical information, giving guidance, answering questions
Recognized for technical expertise in specific document development
Network with others to identify and share best practices globally
Bachelor’s degree in a scientific, health, or technical related field OR Bachelor’s degree in any field with at least two years of clinical development experience
Cognitive abilities including; verbal reasoning, attention to detail, critical thinking, and analytical ability
Demonstrated project management and time management skills
Ability to work well across cultures and time zones
Ability to work well independently and as part of a team
A writing exercise is required as part of the candidate evaluation process. Additional writing samples may be requested

Medical Writer Resume Examples & Samples

Manage the delivery of Medical Writing activities (CEPs/CERs) and perform project management for Publication delivery across Lifecycles as specified
Medical Writing Experience with focus on Clinical Evaluation Plans/Clinical Evaluation reports (CEP/CERs) and project management experience
Clinical Research
Good Clinical Practice
Good spoken and written English

Medical Writer Resume Examples & Samples

BS degree in pharmacy or Doctoral level degree in a biomedical field
2 years experience in searching the biomedical literature
2 years experience in interpreting and using medical communication documents
Knowledge of biomedical and pharmaceutical databases (e.g. MEDLINE, CANCERLIT, EMBASE, BIOSIS, IPA) and vendors for accessing them (e.g. DIALOG, OVID, SILVERPLATTER)
Detail-oriented. Methodical. Goal-driven. Good judgment. Able to work with minimal supervision
Computer skills [word processing, spreadsheet, bibliographic management]
Good interpersonal skills. Ability to work within a team

Principal Medical Writer Resume Examples & Samples

Provides medical writing expertise for multiple compounds and/or projects across all therapeutic areas within CPPM
Implements all activities related to the preparation, submission, and revision of scientific publications (eg. abstracts, posters/oral presentations, manuscripts)
Leads the authoring, review, and approval processes with appropriate functions involved in the production of scientific publishing projects
With input from authors, converts relevant data and information into a form that is appropriate for the target audience and meets journal or congress requirements
Confirms completeness of information to be presented
Proactively identifies gaps and inconsistencies and proposes ways to resolve them
Understands/complies with appropriate conventions, proper grammar usage, format requirements per journal/congress, and internal policies to ensure preparation of high-quality scientific publications
Independently resolves document content issues and questions arising during the writing process; drives manuscript preparation and submission to completion
Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to scientific publications
Acts as Subject Matter Expert for best practices in manuscript preparation and submission
Maintains expert knowledge of guidances (eg, ICJME, CONSORT, GPP3) associated with scientific publications
Coaches, mentors, and assists medical writers and provides guidance to non-AbbVie medical writers and external vendors/agencies
Learns and applies knowledge of the therapeutic area and product to scientific publishing projects
BS/MS/PhD/PharmD with significant relevant writing experience
American Medical Writing Association (AMWA) certification or other preferred,
Highly developed written and oral communication skills
Knowledge of pharmacokinetics concepts preferred
Familiarity with journal requirements for graphs and figures preferred
Ability to find and correct errors to ensure consistency, clarity and accuracy within and across publications
Excellent working knowledge of software programs (MS Office, Endnote, Adobe Acrobat, etc.)
Extensive experience working in cross-functional team environments

Medical Writer, Research & Development Resume Examples & Samples

Proficiency in MS Office applications (Word, PowerPoint, Outlook, Excel) and Adobe Acrobat
Proficiency with medical literature search tools (e.g., PubMed, TOXNET, etc.)
Proven ability to research medical/scientific topics, analyze the information, and summarize for target audiences
Familiarity with common medical and scientific style guides and conventions
Excellent interpersonal communications skills; ability to interact with cross-functional product development teams
Ability to work independently and collaboratively
Excellent organizational and problem-solving skills
Ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high-quality documents within tight timelines
At least 6 years of medical writing experience (industry or academic) that includes research writing
LI-CC1

Principal Medical Writer Resume Examples & Samples

Experience in oncology
Excellent interpersonal, negotiation, verbal and written communication skills
Client focused approach to work
Motivation to work consistently in a fast-paced, rapidly changing environment
Team orientated
Leadership skills that include the ability to gain trust and confidence with a variety of clients as well as within the company
Knowledge of resource management and productivity metric management
Strong word processing skills, including familiarity with MS Word for Windows
Fluent in written and spoken English
Broad experience in preparation of all types of clinical regulatory documentation. Experience in management of complex medical writing projects

Senior Medical Writer Resume Examples & Samples

Collaborate with the clinical team to write clinical documents for regulatory submissions, including but not limited to: clinical evaluation reports, interim and final clinical study reports, briefing documents, previous human experience summaries, investigator brochures, study protocols, and informed consents for the assigned projects
Researches, creates, and edits assigned clinical reports, documents and scientific presentations associated with clinical research in cooperation with the Clinical Team, KOLs and physician investigators for the THV Clinical program
Act as Scientific Communications representative in core team meetings in the development of reporting plans and regulatory submissions (US and international) for clinical studies
Request and/or conduct literature searches, managing the literature database and prepare literature reviews for external and internal clients
Provide leadership, training, and guidance and act as a mentor to less experienced medical writers
Evaluate the need for scientific content and assist in the creation of clinical educational materials for the global Sales & Marketing organizations
Project Lead for medical writing deliverables for assigned clinical studies. This may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues with clinical project managers, field teams, clinical data management and biostatistics groups
A Bachelor’s degree required. Advanced degree preferred (Ph.D., MD, Sc.D., M.S., and M.P.H.)
Minimum of 5 years scientific experience with an Advanced degree or a minimum of 7 years with a Bachelor’s degree
Experience in development of regulatory submissions (preferably as a medical writer for pharmaceutical, CRO, or medical device clients)
Ability to provide leadership and guidance; skilled in coaching and training techniques
Experience as author or contributor or peer-reviewed manuscripts is strongly desired
Working knowledge of statistics is required
Excellent writing and editing skills, and a keen attention to detail
Strong verbal, written, and interpersonal communication skills
Highly proficient in the use of Microsoft Office applications (Word, Excel, PowerPoint) and EndNote
Strong verbal as well as written communication skills necessary
Ensure compliance with good publication practices (GPP)
Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature databases

Senior Medical Writer Resume Examples & Samples

Act as Clinical Program Medical Writer (as assigned). Provide process, content, and planning expertise to Clinical Trial Team, Clinical Satellite Team, and Submission Team regarding document preparation, submission strategy and consistent scientific messaging. Advise team on Medical Writing resource utilization, efficiencies, timelines, and interdependencies. Oversee preparation of clinical submission documents for a program; review and provide feedback on clinical submission documents to maintain consistent content, messaging, and style
Participate in and/or lead the development of processes and tools related to authoring and reviewing of clinical documents. Continually share best practices in an effort to create higher quality documents more efficiently
Maintain and demonstrate expert knowledge of company- and project-specific guidelines for the generation of clinical submissions documents, including SOPs, templates, and document writing conventions and styles
Liaise with vendors/external contractors as assigned. Ensure timelines and quality of product when the writing of a document is outsourced
Mentor, coach, and/or otherwise assist in the training and development of (Senior) Medical Writers
Bachelor’s degree required, Master’s or PhD preferred
Professional certifications (e.g., AMWA, EMWA, RAPS, etc.) is a plus, but not essential
Signifant experience in Medical Writing in the Biopharmaceutical industry or equivalent
An advanced degree (e.g., Master's, PhD, etc) may be considered in lieu of years of experience
Regulatory writing experience is required
Ability to work under stress
Ability to multi-task and to respond rapidly to changing priorities and aggressive timelines
Expert knowledge of medical, pharmaceutical, and clinical research concepts

Medical Writer Resume Examples & Samples

Responsible for developing the non-scientific portions of a standard research protocol (such as registration, record-keeping and regulatory compliance sections). Collaborate with the investigator to draft non-scientific/clinical aspects including project scope. Review the entire protocol document for consistency, clarity, formatting and correct grammar. May assist with Letter of Intent and Informed Consent Form development
Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree with a minimum of 2 years of relevant scientific writing experience; OR appropriate combination of education and experience
Understands and interprets financial statements and reports; reconciles financial records
Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree; OR appropriate combination of education and experience

Senior Medical Writer Resume Examples & Samples

Travel (approximately 0%) domestic and/or international
Independently write clinical study reports and other regulatory documents according to ICON or client-specified formats. *
Independently write patient narratives for serious adverse events and drop-outs due to non‑serious adverse events. *
Independently provide additional writing and editing services (e.g. for publications) as required. *
Advise on the content and format requirements for clinical reports and regulatory documents. *
Perform quality control (review) of documents and assess whether specific project related documents comply with regulatory requirements, client requests and ICON SOPs. *
Liaise with internal groups, i.e. Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, Clinical, and Quality Assurance to ensure the timely implementation of activities related to the production of documents. *
Independently interact with clients to obtain necessary and relevant information, and deal with queries through effective decision making. *
Maintain awareness of the contractual and financial aspects of assigned projects and projects to which oversight responsibilities have been assigned
Participate in non-project specific activities, including assistance in maintaining the medical writing work schedule. *
Be responsible for the daily management of assigned medical writing projects. *
Keep Medical Writing management informed of project status (e.g. in relation to quality, timelines, progress, and problems). *
Participate in the training and supervision of new and junior medical writers. *
Represent Medical Writing at internal and external meetings. *
Assist Business Development with the preparation of proposals and cost estimates for medical writing tasks. *
Any other task deemed reasonable by department senior management

Senior Medical Writer Resume Examples & Samples

A Master’s degree or equivalent in life sciences or economics and, preferably, a postgraduate position in a health related discipline
Relevant experience within a consulting or pharmaceutical industry environment
Three (3) or more years of relevant pharmaceutical/medical writing experience
Ability to read, analyze, and interpret clinical data from a variety of scientific sources
Ability to develop presentations and articles for peer reviewed publications that conform to prescribed styles and formats
Excellent demonstrable understanding of ICMJE and GPP guidelines and regulations
Knowledge of Internet software, Spreadsheet software, Word Processing software, Graphics software (eg, PowerPoint or Prism), Bibliographic software (eg, EndNote) and any other applicable software as may be needed by the job from time to time as it evolves
Knowledge of process for obtaining market access for drugs or devices
Well-developed written and oral communication skills
Ability to work effectively as part of a team
High self-motivation
LI-PR1

Senior Medical Writer Resume Examples & Samples

Publications (abstracts, posters and slide presentations for conferences and other scientific meetings, and manuscripts for scientific journals)
To liaise with the CMRs’ medical/marketing functions on local publication activities
Other relevant ad-hoc documents
Participate in internal/external marketing/medical activities, e.g., expert meetings, lectures and conferences
Contribute to ongoing improvements in cross-functional and global collaboration and sharing of better practices and knowledge
Maintain up-to-date knowledge and competencies within relevant therapeutic and professional areas
Actively participate in relevant meetings, training sessions and seminars in the department, competency anchor and relevant project(s)
Maintain a good working relationship with stakeholders and colleagues
≥3 years of experience with scientific research methodology, including designing and conducting experiments, and analysing and reporting experimental results
Experience with scientific writing in English (publications for peer reviewed journals or equivalent)
Experience working within a global setting
Strong understanding of external requirements related to regulatory documents
Experience from the pharmaceutical /CRO industry
Good experience with drug application processes to FDA and EMEA

Oncology Principal Medical Writer Resume Examples & Samples

Is recognized as a significant scientific contributor and subject matter expert in preparation of regulatory clinical documentation
Oversees the work of other medical writers, providing scientific and operational mentorship and coaching in the design, planning, and execution of their assignments. Provides feedback to their managers on development plans and performance reviews
Provides leadership for medical writing processes, standards, and innovative initiatives
Successful preparation of Common Technical Document clinical modules

Oncology Senior Medical Writer Resume Examples & Samples

Applies developing knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects. Participates as part of the medical writing team in cross-functional teams (either internally or externally)
May participate in orientation and coaching of junior team members or contractor writers
This is a remote based position. The ideal candidate will be based in NC, SC, TN or GA
Ability to prepare, with minimal supervision a subset of clinical regulatory documents (e.g., CSR, IB, clinical sections of IND/IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines
Participate actively in medical writing and cross-functional project teams

Senior Medical Writer Resume Examples & Samples

Is recognized as a scientific contributor and subject matter expert in preparation of selected regulatory clinical documentation
Demonstrates competence in writing, editing and reviewing of clinical study reports, investigator brochures, registration dossier modules, and other clinical regulatory documents in line with expectations. Able to interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation
Manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings. Works collaboratively with colleagues across functions to achieve results
Solves problems associated with medical writing scope of work, seeking advice from management and others as needed, and exercising negotiation and communication skills with project team members

Senior Medical Writer, Oncology Resume Examples & Samples

In accordance with authors’ direction, provides medical writing and editing expertise for abstracts, posters, oral presentations, and manuscripts
Responsible for compliance with applicable corporate policies and procedures
Works effectively with cross-functional stakeholders

Senior Medical Writer Resume Examples & Samples

Bachelor’s or Nursing degree required
Experience Required
Master’s Degree or PH.D preferred
Experience in the conduct of clinical research/medical communications preferred
Specialized medical writing knowledge
Experience in medical writing of regulatory documents such as patient narratives, informed consent forms, experience papers, manuscripts required
Expertise in the medical device industry
Preferred experience with Respiratory Science
Experience with Ednotes, Powerpoint, Microsoft Word preferred

Principal Medical Writer Resume Examples & Samples

Medical device industry experience or related industry experience that demonstrates mastery and in depth knowledge of medical device and/or combination product trials and regulations
Clinical research experience
Strong knowledge of regulatory guidance relative to Clinical Evaluation Reports, and the essential requirements for safety and performance of Medical Devices as defined in Annex I of the Medical Device Directive 93/42/EEC and Annex I of the Active Implantable Medical Device (AIMD) Directive 90/385/EEC,(Annex I Section 6a and Annex X (MDD) / Annex 1 Section 5a and Annex 7 AIMD), the MEDDEV and EN ISO 14155
Preferable experience in Cardio-vascular sciences
Direct experience demonstrating mastery of medical and/or scientific writing within a medical device or related industry, preferably with writing of Clinical Evaluation Reports
Strong complex project leadership skills and excellent interpersonal communication skills
Functional knowledge of biostatistics with an understanding of the publications process
Computer skills (Microsoft Word, Excel, Project or equivalent)

Senior Medical Writer / CER Specialist Resume Examples & Samples

5+ years experience (4+ years with Masters or 3+ with Doctorate, or Board Certified MD or DVM)
Medical writing experience
Clinical Research experience
Medical device experience
Professional clinical research certification (e.g., Association of Clinical Research Professionals, Society of Clinical Research Associates)
Advance degree in related field (i.e. systems, reliability, safety engineering)
Previous experience in the application of in-depth therapeutic and device knowledge to development of clinical evaluation reports
Analyzes complex issues and significantly improves, changes, or adapts existing methods
Ability to work with little direction towards predetermined long-range goals and objectives. &#96
Proficient knowledge and understanding of medical terminology, clinical practices, physiology and/or applicable disease states, Neuromodulation therapies and technologies
Process improvement capability
Ability to identify and implement solutions in addressing project issues
Ability to achieve objectives and milestones through identification and implementation of work plans and measurements
Ability to identify and adapt to shifting priorities and competing demands
Ability to maintain composure in difficult circumstances, and identify and overcome obstacles
Strong knowledge and understanding of Good Clinical Practices and regulatory standards
Excellent critical and analytical thinking skills
Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing; demonstrated effective scientific writing skills
Ability to identify critical information needs and identify roles / individuals to involve for decision making within clinical evaluation assessment and report development
Strong ability to determine and pursue courses of action necessary to obtain desired results
Proficiency in word processing tools, spreadsheets, and/or database applications (e.g., MS Word and Excel)
High attention to detail and accuracy
Ability to identify customer/stakeholder requirements, and constructively respond to feedback/comments/inquiries
Project management capability

Medical Writer Resume Examples & Samples

Understand and interpret study objectives and clinical trial data and the regulatory and scientific requirements of the documents we prepare
Confidently work with others to develop study protocols from brief outlines, and take responsibility for a variety of clinical documents for a wide range of both international and local sponsors, across all therapeutic areas
Interact directly with international project team members and sponsors, proactively manage his/her own deliverables, and identify and respond appropriately with solutions to any potential issues and problems
Multi-task, balancing project lead roles with review responsibilities for others, and helping out colleagues in the team on a planned or ad hoc basis
Work with minimal direction on most assignments, identify project needs, and create project timelines
Review the work of others and provide appropriate feedback

Principal Medical Writer Resume Examples & Samples

Minimum of a Master’s degree in a related field required. PhD or other doctorate degree preferred
A minimum of 4 years relevant medical, scientific and/or healthcare writing experience is required
The ability to interpret, analyze and summarize/visualize clinical and statistical data obtained in scientific research is required
A good understanding of experimental methods and study design is required
Experience in the real world evidence and health economics and outcomes research fields, including studies utilizing claims data and/or EMRs/EHRs is preferred
Superior writing and editing skills are required. Lead writer experience is preferred. Documents must be of high quality with respect to scientific content, organization, clarity, accuracy, format and consistency
Relevant pharmaceutical, health outcomes, clinical and/or scientific experience is preferred
Exposure to pharmaceutical strategies and tactics to meet both commercial and scientific communication objectives for a given product is preferred
An understanding of statistical analysis is preferred
Experience with templates and document management systems are required
Excellent skills in collaboration and influencing are required
Strong interpersonal and communications skills (both written and oral) are required
Proficiency with computer, word processing and presentation (i.e. PowerPoint) and basic Excel skills are required
Strong time-management and project planning skills are preferred
Experience with preparation and submission of publication deliverables (abstracts, posters, manuscripts) is preferred
Working knowledge of regulatory and commercial compliance issues relating to conducting research and dissemination of scientific information preferred
This position may require up to 10% domestic travel.Medical Writing

Senior Medical Writer, Work From Home Resume Examples & Samples

Thorough understanding of GCP, ICH guidelines and local regulations
Knowledge of clinical trials design, the oncology disease process, basic statistics, pharmacokinetics and other aspects of the drug/clinical trial development
Excellent problem-solving, planning, analytical, and organizational skills
Strong verbal, written and interpersonal communication skills are essential
Skill with Microsoft Office products, including Outlook, Word and Excel
Flexible attitude with respect to work assignments and new learning opportunities
Ability to work within deadlines
Ability to multitask and prioritize workload with attention to detail required
Three years minimum of relevant medical writing experience or relevant clinical research experience
Two years’ experience as a CRA/Study Manager, compliance auditor, or a combination in healthcare, clinical research or other science-related field – if document preparation was a primary responsibility
Experience with preparation of clinical and/or regulatory study-related documents and/or research publications desired; experience with regulatory documents and processes beneficial
Clinical research/medical writing experience: experience, including phase I- III, in writing multiple clinical study reports, and either CTD documents or similar, or study protocols

Clinical Research Medical Writer Resume Examples & Samples

Possession of a Bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in biological/biomedical science or related field or 4 years related experience in lieu of degree
A minimum of two (2) years’ experience in a pharmaceutical, biotechnology and/or clinical environment which includes medical and/or regulatory technical writing/editing
Experience participating in the preparation of clinical documents for regulatory submissions (e.g., clinical protocols, Investigational New Drugs [INDs])
Ability to effectively communicate both verbally and in writing with demonstrated expertise with grammar, syntax, and format
Ability to work in a clinical research regulatory setting, both independently and within a team, to coordinate, negotiate and facilitate the program goals
Proficiency in word processing systems, i.e., Microsoft Word, MS Office, or similar systems
Familiarity with therapeutic area of allergy and infectious diseases

Senior Medical Writer Resume Examples & Samples

Clinical trial reports (CTRs)
Clinical trial results presentations for distribution to clinical investigators
Investigator’s brochures (IBs)
Clinical summary documents in CTD/eCTD format for regulatory submissions world-wide (including investigational medicinal product dossiers (IMPDs), investigational new drug applications (INDs), marketing authorisation applications (MAAs), new drug applications (NDAs), variations and supplemental new drug applications (sNDAs))
Solid experience with drug application processes to FDA and EMEA

Oncology Managing, Medical Writer Resume Examples & Samples

Ability to prepare, without supervision, any type of clinical regulatory document (e.g., protocol, CSR, CIB, clinical sections of IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines
Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management
Active involvement in professional organizations

Medical Writer Resume Examples & Samples

Ensure critical review and interpretation of clinical efficacy and safety data for appropriate medically relevant and Standard Operating Procedure (SOP)
Prepare clinical submission documents for a regulatory audience, within a team environment, according to APV SOPs and templates
Manage review and approval process of clinical submissions documents, which includes authoring documents in a team environment, generating consensus among reviewers, and facilitating discussions in an efficient manner
Participate in the development of processes and tools related to document authoring, management, and quality control in support of the departmental goal to develop best-in-class processes, tools, and standards to foster open communication, quality, efficiency, and cost-effectiveness of clinical document generation to support the delivery of high-quality documents within realistic and ambitious timelines. Share expertise within Medical Writing and therefore across Therapeutic Areas

Principal Medical Writer Resume Examples & Samples

Acts as Lead Medical Writer on any type of writing project, with limited guidance from senior staff, and consistent high quality and efficiency
Participates in both internal and external project team meetings and liaises directly with the customer on medical writing issues, as appropriate and with senior support as needed
Arranges appropriate internal review of assigned documents and takes responsibility for on-time delivery. Identifies project needs, negotiates and tracks project timelines, and implements client requests with limited senior guidance
Offers proactive solutions and advice to customers as appropriate to experience
Reviews and monitors budget for assigned projects, including out of scope activities, and ensures that revenue is recognized as appropriate
Provides senior review and guidance for documents prepared by junior staff
May act as Project Manager for stand-alone Medical Writing projects or as primary medical writing customer contact for one of our partnerships
May coordinate Medical Writing activities for a series of full-service projects, with attendant focus on efficiencies, consistency, budgetary concerns, client liaison, and tracking

100

Safety Medical Writer Resume Examples & Samples

Medical Doctor, Dental doctor, Master degree in pharmacy or equivalent medical and scientific background
Experience with scientific writing in English (publications or equivalent)
Specific personal and job-related demands (communication skills, ability to take initiative, flexible attitude, ability to work independently/in a team, personal traits necessary in the job, etc.)

101

Senior Medical Writer Resume Examples & Samples

Communicates with and works effectively and productively with all authors on the development of scientific publications
Understands and interprets data generated from a variety of sources, including internal and external studies, research documentation, charts, graphs, tables, and published literature
Creates figures and tables for publications that effectively communicate the data and adhere to journal/congress requirements
Coordinates the review, approval, submission, and production of publications
Ensures publications are developed in accordance with the established timelines
Effectively manages all assigned publication projects, including outsourced projects to vendors
Utilizes Datavision publication management system, and ensures accuracy of publication records and resourcing tools for assigned publication projects
Learns and maintains therapeutic area and product knowledge and applies to projects
Maintains current awareness of good publication practices and editorial policies and applies to publishing projects
Addresses document content issues and questions that arise
Independently identifies conflicts affecting assigned publications and resolves or elevates to ensure resolution

102

Medical Writer Resume Examples & Samples

Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification
Experience working in the pharmaceutical/CRO industry preferred
Solid medical writing skills, including grammatical, editorial, and proofreading skills
Ability to interpret and present complex data accurately and concisely
Effective administrative, organizational and planning skills; attention to detail and quality
Ability to work on own initiative and effectively within a team
Good knowledge of regulatory documentation and drug development process
Good computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)

103

Lead Medical Writer Resume Examples & Samples

Experience in clinical documents related to late phase studies
NDA experience with active contribution in planning and preparation of summary documents is required
Facilitate Clintrials.Gov results postings
Ability to independently plan and prepare Clinical and Regulatory Documents
Flexibility/adaptability to work in a fast-paced and dynamic environment
Proficient with MS Office and other related software programs
Experience in managing people and projects
Experience in working with cross-functional teams and engage/escalate to ensure quality deliverables in planned time frame
5+ years of industry experience as Medical Writer
Participation as writing lead on at least one NDA/MAA submission

104

Medical Writer Novella Clinical Resume Examples & Samples

Prepares Sponsor documents that include but are not limited to Clinical Study Reports, protocols, manuscripts, abstracts, Investigator’s Brochures, integrated summaries of efficacy and safety, informed consents, patient narratives, responses to health authorities, and clinical trial results posting (ClinicalTrials.gov)
Ensures that clinical documents comply with FDA regulations, ICH Guidelines, and appropriate SOPs
Will be responsible for creating timelines associated with writing projects and will need to work within the budget assigned per project
Coordinates the internal team, QC, and QA review of documents
Will be in direct contact with internal and Sponsor team members
Reviews and edits documents written by other departments, as necessary
Prepares clinical documents for electronic publishing
Explains and instructs information systems concepts and procedures to non-technical staff
Ability to research and review clinical content effectively and translate clear and concise messages
Excellent communication skills (oral and written)
Must have outstanding analytical and research skills
Must have the ability to decipher complex clinical and statistical data
Requires an understanding of clinical regulatory documentation requirements
Proficient computer skills, specifically with the use of MS Word templates and style features, Excel, and PowerPoint
Displays knowledge of standard editorial/style conventions (eg, AMA Manual of Style)
Proven ability to manage multiple projects and to work well in a collaborative environment
Ability to work independently and be a team player

105

Lead Medical Writer Resume Examples & Samples

Leads the writing strategy providing expertise including organization, content, timelines, and resource requirements
Within designated therapeutic or compound function, manages deliverables and preparation of documents for submission to FDA or other regulatory agencies, ensuring consistency of content within therapeutic areas and adherence to regulatory requirements and Takeda requirements and processes across development programs
The Principal Medical Writer Program Lead is seen as an expert in medical writing and performs work independently with minimal supervision
At least 5 years experience writing for pharma or biotechnology required. 3+ years of electronic documents and submissions required
Experience as lead writer for key documents included in major US and/or international regulatory submissions required
Experience managing writing activities for a major US or international regulatory submission (project or people management) preferred
Ability to understand Takeda guidelines and requirements related to the preparation and production of regulatory documents and submissions
Well-developed oral and written communication skills; ability to clearly present technical information within and across functional areas
Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within functional and cross-functional teams and with external providers

106

Principal Medical Writer Resume Examples & Samples

The ability to manage multiple and varied tasks with enthusiasm and to prioritize your work while paying attention to details
A bachelor’s degree in Life Sciences/Health-Related Sciences or equivalent experience
Fluency in written and spoken English

107

Medical Writer Resume Examples & Samples

Creation and maintenance of technical documentation for products manufactured in Wiesbaden or other Abbott sites
Create, update and maintain technical documentation
Apply change control for technical documentation
Use different document management systems (e.g. APLM, DMS, ELN) to obtain technical data
Use different document management systems (e.g. DTS, IRIS) for technical documentation storage and tracking
Work in conjunction with Technical Operations, R&D, Quality, Compliance, Medical Affairs and Regulatory functions in Wiesbaden or other Abbott sites

108

Senior Medical Writer Resume Examples & Samples

Acts as Lead Medical Writer on most types of writing project, with limited guidance from senior staff. Takes responsibility for preparation of assigned documents to a high standard, working in accordance with Quintiles SOPs and the customer's requirements. Participates in both internal and external project team meetings and liaises directly with the customer on medical writing issues, as appropriate and with senior support as needed. Identifies project needs, negotiates and tracks project timelines, and implements client requests with limited senior guidance. Arranges appropriate internal review of assigned documents and takes responsibility for on-time delivery. Takes responsibility for planning and organizing workload for assigned projects and tasks. Offers proactive solutions and advice to customers as appropriate to experience
Reviews and monitors budget for assigned projects, including out of scope activities, and ensures that revenue is recognised as appropriate. May review ballpark budgets and routine costings, with management support as needed
May review documents or parts of documents prepared by other Medical Writers and provide appropriate feedback. Gives guidance to less experienced Medical Writers and assists in their training and development
May present on standard Medical Writing processes at full-service bid defence meetings by telephone or in person. May input into and deliver presentations on Medical Writing to other Quintiles groups
May act as Project Manager for a small stand-alone Medical Writing project (e.g. protocol or CSR). May coordinate Medical Writing activities for a series of full-service projects, with attendant focus on efficiencies, consistency, budgetary concerns, client liaison, and tracking
Keeps abreast of current data, trends, medical writing/regulatory knowledge, developments and advances in area of drug development/medical writing
May propose revisions to SOPs or suggest process improvements for consideration. Complies with Company SOPs and participates in the implementation of new SOPs
Bachelor's degree in a life science-related discipline, with at least 3.5 years' broad-ranging experience as a medical writer within a pharmaceutical environment, including lead writer roles in preparing clinical study protocols and reports; or equivalent combination of education, training and experience
Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally
In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents
Demonstrated ability and experience to work independently on most writing projects, with limited senior guidance
Understanding of the time needed to perform routine Medical Writing tasks, agree appropriate timelines, and provide accurate resource estimates and costings. Knowledge and understanding of necessary budget assumptions
Ability to give a presentation to a project team and/or customer on project-specific topics, with an air of competence and authority
Ability to effectively review a statistical analysis plan
Knowledge of regulations relevant to medical writing

109

Medical Writer Resume Examples & Samples

Ensures a consistent style of presentation of clinical document to maintain quality and ease of review, and adherence to company standards
Works effectively with company document management system and related tools, templates, and procedures in order to ensure efficient publishing of documents and dossiers
Experience as a Medical writer (preferably >3 years), or equivalent, or presenting relevant specialist qualifications (eg, PhD, PharmD)
Good understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology
Detail-oriented with excellent inter-personal and communication skills
Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system
Ability to work both independently and collaboratively with a team in a cross-cultural, and geographically dispersed environment
Specific knowledge of company-targeted therapeutic areas is strongly desirable

110

Medical Writer Resume Examples & Samples

Acts as Lead Medical Writer and performs competently on straightforward projects, with guidance from senior staff as required. Takes responsibility for preparation of assigned documents to a high standard, working in accordance with Q2 Solutions SOPs and the customer's requirements. Identifies project needs, tracks project timelines and implements client requests with senior review
Participates in both internal and external project team meetings and liaises directly with the customer on medical/technical writing issues, as appropriate and with senior support as needed
Facilitates appropriate internal review of assigned documents and takes responsibility for on-time delivery
May perform QC review of documents or parts of documents prepared by more senior staff
Takes responsibility for managing day-to-day workload for assigned tasks and projects, in collaboration with senior staff
Keeps abreast of current data, trends, medical and/or technical writing/regulatory knowledge, developments and advances in area of drug development/medical and/or technical writing
Complies with Company SOPs and participates in the implementation of new SOPs
Familiarity with the structural and content requirements of clinical or method validation and study reports, protocols, and similar documents for internal and external clients
Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner
Competence in completing good first draft technical reports or clinical reports within a reasonable timeframe with limited guidance
Good understanding of common statistical methods used in clinical trials or pharmaceutical work and/or interpretation of their results
Ability to give a simple presentation to a project team and/or customer, e.g. on medical/technical writing processes
Ability to identify inconsistencies and deficiencies in statistical output as related to acceptance criteria according to SOPs
Ability to work on several projects at once while balancing multiple and overlapping timelines
Ability to assess workload and suggest prioritization to senior staff
Demonstrated abilities in collaboration with others and independent thought
Demonstrates confidence and maturity in most routine medical/technical writing situations
Knowledge of regulations relevant to medical/technical writing, such as Good Laboratory Practices (GLP) and other relevant regulatory agencies (e.g., OECD, MHLW)
Careful attention to detail and accuracy
Must be computer literate
Ability to establish and maintain effective working relationships with coworkers, managers and clients

111

Medical Writer Resume Examples & Samples

Serves as primary author who writes and provides input on routine documents such as abstracts, posters, standard response letters, manuscripts, clinical study reports, and study protocols, and summarizes data from post-approval/MARO studies
May assist with unique and/or more complex clinical and scientific and program level documents, such as customized written responses, REMS/RMPs, and review articles
Ensures compliance with quality processes and requirements for assigned documents. May assist in determining best practices, methods and techniques for achieving optimal results
May assist in program management and/or proposal activities. Duties could include assisting with developing timelines, budgets, and forecasts for assigned deliverables
Represents the department at project launch meetings, review meetings, and project team meetings
Effective medical writing skills, including grammatical, editorial, and proofreading skills
Effective administrative, organizational, and planning skills; attention to detail and quality
Working knowledge of regulations applicable to project work as well as drug development process
Sound judgment and decision-making skills
Good computer skills and skilled with the use of document templates
Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)

112

Medical Writer Resume Examples & Samples

Development of scientific content (including slide decks, monographs, abstracts, article reviews, congress reports, etc…)
Tasks included in the assignments
Native English speaker with a solid understanding of Medical English
Must have a Health Science Degree (Biology, Pharmacy, Medicine)
A minimum of 2 years of medical writing experience
Ability to communicate medical/technical information to a wide variety of audiences
Ability to work in a deadline-driven environment
Attention to detail and absolute reliability in meeting delivery deadlines

113

Medical Writer Resume Examples & Samples

Bachelors Level of Degree in the life sciences or communications/journalism field of study
5+ years of demonstrated experience in medical writing/editing in the medical device, pharmaceutical, or CRO environment
AMWA or advanced degree (MS/MPH/MA or PhD) preferred

114

Senior Medical Writer Resume Examples & Samples

Approximately 3-5 years experience in the preparation of clinical documentation
Ability to write fluent and grammatically correct English with an understanding of medical and scientific terminology and procedures
Good word processing skills
Good organizational and time management skills
Ability to work to tight timelines while maintaining accuracy
Ability to work to a variety of client-driven specifications
Good team player
Familiarity with quality assurance and quality control

115

Medical Writer Resume Examples & Samples

Acting as a lead writer responsible for preparation of clinical study protocols and clinical study reports (CSRs), and other clinical documents as needed
Support more experienced writers with the preparation of complex clinical documents
Interpretation of clinical, pharmacokinetic, pharmacodynamics and statistical results as appropriate
Production of scientific publications and other documents (e.g. abstracts, posters, manuscripts etc. )
Coordination of other writers on CSR appendices compilation and narrative projects
Preparation and review patient safety narratives and CSR appendices
Timely delivery of high quality documents to internal customers and Sponsors
Collaboration with management team to provide training to Medical Writers to ensure best working practices are maintained
Fostering excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time

116

Medical Writer Resume Examples & Samples

Independent preparation of clinical study protocols and clinical study reports (CSRs), and other documents as needed for lower complexity studies
Support for more experienced writers with the preparation of clinical study protocols and CSRs, and other clinical documents as needed
Preparation and review of clinical documents such as patient safety narratives and CSR appendices
Delivery of high quality documents to internal customers and Sponsors
Provision of training for Associate Medical Writers and other staff as appropriate

117

Associate Medical Writer Resume Examples & Samples

Excellent command of written and spoken English
Knowledge of MS Word
Good organizational and time management ability
Scientific or Clinical research experience desirable

118

Senior Medical Writer Resume Examples & Samples

Minimum of 3 years’ experience in the preparation of clinical documentation
Experience with Regulatory Guidances for ICH-E3 Clinical Study Reports and some familiarity with the Clinical (Efficacy or Safety) Sections of the Common Technical Document (CTD)
Expertise in a specialized area of Medical Writing which is required for production of critical regulatory documents (e.g. patient narratives and pharmacovigilance documents)

119

Clinical Research Medical Writer Resume Examples & Samples

Possession of a Bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in biological/biomedical science or four (4) years of experience in lieu of degree
No additional experience beyond a Bachelor’s degree
Knowledge of Department of Health and Human Services (DHHS) regulations, International Conference on Harmonization/Good Clinical Practices (ICH/GCP), Food and Drug Administration (FDA), and Office of Human Research Protections guidelines
Must be able to obtain and maintain a security clearance
Experience in a pharmaceutical, biotechnology and/or clinical environment which includes medical and/or regulatory technical writing/editing would be a plus but does not exclude those who do not

120

Medical Writer / Senior Resume Examples & Samples

Write and edit clinical study reports, study protocols, investigator’s brochures, clinical data summaries, and other medical/regulatory documents
Represent medical writing on project teams through collaborative engagement with personnel from other clinical disciplines, regulatory affairs, and scientific departments
Participate in the development of abstracts and slides or posters presenting clinical study data to medical congresses and the development of primary manuscripts for peer-reviewed journals
Prior NDA/BLA/MAA submission experience required; eCTD preferred
Must have a solid understanding of FDA/ICH guidelines and GCPs
Must have strong written and verbal communication skills, and expert abilities in Microsoft Word, Excel, and PowerPoint; experience with Adobe Acrobat preferred
Must have the ability to coordinate and prioritize multiple projects in a fast-paced environment
Background in oncology drug development is a plus

121

Medical Writer Resume Examples & Samples

Typically minimum 3 years medical writing experience including 1 year as medical writing project lead
In-depth knowledge of MS Word
Knowledge of ICH guidelines applicable to medical writing
Good understanding of medical/scientific terminology and experience in data analysis and interpretation

122

Senior Medical Writer Resume Examples & Samples

BS/BA in a scientific discipline(or licensed certification) with 4+ years relevant writing experience or
Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities
Must possess the ability to manage large projects with minimal supervision
Must demonstrate an ability to serve as a departmental resource for training, mentoring, and the development of process improvements for Medical Writing

123

Medical Writer Resume Examples & Samples

To stay abreast of the latest pharmaceutical developments by finding, reading and comprehending FDA drug and device alerts, medical white papers, Big Pharma reports, SEC and court filings
To supplement FDA materials with other high-level sources
To write accurate accounts of prescription drug or device histories and side effects for general information websites and legal websites
To fact-check and proof existing and new web pages, news articles and blog posts
To write (and sometimes ghostwrite) content for outside blogs and websites
To support the Managing Editor by serving as a resource for other writers on the team
To work a 40-hour week, Monday through Friday, in an office setting
Experience reading and writing about Big Pharma
Editing or proof-reading experience
Experience dealing with lawyers on a professional level

124

Senior Scientific Medical Writer Resume Examples & Samples

Include assuring quality and timely preparation of clinical documents as assigned, including clinical study reports, clinical study protocols, and support for clinical summaries and overviews
Act as the medical writing expert responsible for managing, writing and editing of study level documents, and supporting submission level documents
Provide full lifecycle support from clinical study concept and protocol through regulatory dossier preparation and submission
Assist the Project Medical Writer in the development of clinical document content used to support successful global clinical development, approval and marketing of new drugs
Implement the content strategy for all clinical documents as assigned
Drive the design of all assigned study level documents in support of the Global Clinical Development Plan (CDP) under the leadership of the Project Medical Writer
Independently author study level documents (collaborating with the team), supports project level submission documents under the leadership of the Project Medical Writer, implements project level data presentation and messaging standards for the assigned documents, validates individual study protocol design and clinical study report (CSR) key messages based on the strategy provided
Be accountable for the format, content and adherence to global and electronic publishing standards of the individual clinical documents that he/she is the author of
Mentor and coach Associate Scientific Medical Writers
A Bachelor’s Degree in natural sciences (Master’s Degree or PhD highly preferred)
6+ years experience in the pharmaceutical industry or if an advanced degree in natural sciences, minimum of 3+ years experience in the pharmaceutical industry
3-4 years’ experience in medical writing within Pharmaceutical or CRO industry, preferably in the field of oncology
Experience in developing clinical documents in support of regulatory submissions globally (ie multiple regions) in a global team environment are highly preferred
The incumbent must have an in depth understanding of all regulatory guidance, standards and requirements pertaining to regulatory medical writing worldwide (eg ICH, FDA, EMEA)
The incumbent must have a thorough understanding of the overall drug development process. Specific knowledge of the clinical study report development process, regulatory and drug safety requirements, and clinical data management and statistical processes/functions is required
The incumbent must also have an excellent working knowledge of current electronic authoring, document management and electronic regulatory submissions
The incumbent must demonstrate strong communication skills, both written and verbal required to articulate concepts and ideas. The incumbent must be diplomatic, persuasive and be able to establish rapport with all key functional leaders and experts in the Global Development organization
Ability to work on-site in Whippany, NJ

125

Medical Writer Resume Examples & Samples

Responsible for planning and preparing high quality medical writing deliverables (e.g., study protocols, clinical study reports, statistical analysis plans, Investigator Brochures, relevant modules of regulatory dossiers, risk management plans, pharmacovigilance ad hoc and periodic reports, briefing books), presentations (e.g., abstracts, posters, Advisory Committees, Advisory Boards) and manuscripts that support the clinical development and regulatory requirements for CR&D
Prior experience of working in the role of medical writer within the CRO/Pharma/Biotech industry
As a guide, a minimum of 4 years Clinical experience in the role of medical writer
Excellent level of English language proficiency
Expert MS Office skills with a special focus on word processing , tables and graphics, spreadsheet presentations and templates

126

Principal Medical Writer Resume Examples & Samples

Leads a single team which guides medical writing activities within a designated therapeutic or functional area for key response documents and regulatory submissions
Coordinates the activities of Takeda, contract employees and vendors (on-site or external), provides review and substantive editing of contributions, and ensures resolution of issues
As required, serves as lead writer for important regulatory response documents and key components of regulatory submissions
The Principal Medical Writer is seen as an expert in medical writing and performs work independently with minimal supervision

127

Senior Medical Writer Resume Examples & Samples

Serves as medical writing lead on scientific publications or clinical regulatory documents. Works closely with the Publications or Regulatory team(s) on document strategies. Implements all activities related to the preparation of scientific publications (e.g. abstracts, posters/oral presentations, manuscripts) or to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (US and ex-US)
Coordinates the review, approval, and other appropriate functions involved in the production of scientific publishing or clinical regulatory projects. Arranges and conducts review meetings with the team. Ensures required documentation is obtained
Converts relevant data and information into a form that meets clinical regulatory document requirements. Explains data in manner consistent with the target audience(s), journal/congress requirements, and/or clinical regulatory requirements
Responsible for effective communication among team members. Communicates deliverables needed, writing process, and timelines to team members. Holds team members accountable to agreed-upon project dates. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.). Identifies conflicts affecting writing projects and resolves or elevates to ensure resolution. Ensures all clinical regulatory electronic document deliverables are pr
Understands, assimilates, and interprets sources of information with appropriate guidance/direction from product teams and/or authors. Interprets and explains data generated from a variety of sources, including internal and external studies, research documentation, charts, graphs, and tables. Verifies that results are consistent with protocols. Confirms completeness of information to be presented. Challenges conclusions when necessary. Identifies and proposes solutions to resolve issues and q
Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per journal/congress, ICH and other governing bodies following applicable divisional guidelines, templates, and SOPs
Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to scientific publications or clinical regulatory documents
Works with Regulatory Quality Assurance throughout clinical regulatory document audit process, answers questions during the audit process (as appropriate), and works with team to draft responses as necessary
Knowledgeable of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions. Learns and applies knowledge of therapeutic area and product to scientific publishing projects. Must continually train/be compliant with all current industry requirements as they relate to scientific publications or clinical regulatory submissions, including electronic submission/approval standards
Serves as a department representative on project teams. Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments (e.g. eDocs, eCTD, journal/congress databases). May mentor and provide guidance to more junior medical writers and/or external vendor/agencies. Implements tactical process improvements

128

Principal Medical Writer Resume Examples & Samples

Researches, writes, and edits clinical study reports and study protocols, and summarizes data from clinical studies
Serves as primary author who writes and provides input on complex clinical and scientific and program level documents, including IBs, INDs, and MAAs
Provides senior level review of routine and complex documents. Provides training and mentorship for other writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge
Ensures compliance with quality processes and requirements for assigned documents. As the subject matter expert, develops and reviews best practices, methods and techniques for achieving optimal results, including various client-specific processes, and leads process improvement initiatives. May also develop, review and manage performance metrics for assigned projects
May serve as backup program manager. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications, and assisting business development with client presentations and proposal text review, and attending bid defense meetings and capabilities presentations
Significant knowledge of global, regional, national and other document development guidelines
In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, communications, etc
Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
Advanced interpersonal, oral and written communication, and presentation skills
Excellent judgment; high degree of independence in decision making and problem solving
Ability to mentor and lead junior level staff

129

Medical Writer Resume Examples & Samples

25 days holiday (increasing with length of service)
Pension scheme (5% of annual salary)
Bonus scheme
Childcare vouchers

130

Senior Medical Writer Resume Examples & Samples

Serves as medical writing lead on clinical regulatory documents. Works closely with the Publications or Regulatory team(s) on document strategies. Implements all activities related to the preparation of publications (e.g. abstracts, posters/oral presentations, manuscripts) or to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (US and ex-US)
Coordinates the review, approval, and other appropriate functions involved in the production of clinical regulatory projects. Arranges and conducts review meetings with the team. Ensures required documentation is obtained
Effectively communicates clinical regulatory document deliverables needed, writing process, and timelines to team members. Holds team members accountable to agreed-upon project dates and with an appropriate quality level. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands. Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or elevation as appropriate
Understands, assimilates, and interprets sources of information with appropriate guidance/direction from development teams. Interprets and explains data generated from a variety of sources. Verifies that results are consistent with protocols. Challenges conclusions when necessary. Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per journal/congress, ICH and other governing bodies
Knowledgeable of US and international regulations, requirements and guidance associated with clinical regulatory document preparation and submissions. Learns and applies knowledge of therapeutic area and product to publishing projects. Must continually train/be compliant with all current industry requirements as they relate to clinical regulatory submissions, including electronic submission/approval standards

131

Principal Medical Writer Resume Examples & Samples

Serves as medical writing lead on more complex clinical regulatory documents such as those associated with filings and dossiers. Works closely with the Publications or Regulatory team(s) on document strategies. Implements all activities related to the preparation of publications (e.g. abstracts, posters/oral presentations, manuscripts) or to the preparation and compilation of data and information into a single comprehensive package for new and updated clinicals
Serves as a subject matter expert within department for assigned therapeutic/product areas. As assigned, provides direction and guidance to medical writers regarding assigned projects, including review of work product. Provides input and feedback to management regarding internal medical writers' work product/quality. Recognizes potential scheduling and resource conflicts for projects across therapeutic area/product assignments and provides recommendations to resolve
Converts relevant data and information into a form that meets clinical regulatory document requirements. Explains data in manner consistent with the target audience(s), journal/congress requirements, and/or clinical regulatory requirements. Coordinates the review, approval, and other appropriate functions involved in the production of clinical regulatory projects. Arranges and conducts review meetings with the team. Ensures required documentation is obtained
Responsible for effective communication among team members. Communicates deliverables needed, writing process, and timelines to team members. Holds team members accountable to agreed-upon project dates. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.). Must identify and resolve conflicts (including document content issues), remove barriers, generate innovative ways to ensure teams achieve project goals
Understands, assimilates, and interprets sources of info with appropriate guidance/direction from product teams and/or authors. Interprets and explains data generated from a variety of sources, including internal/external studies, research documentation, charts, graphs, and tables. Verifies that results are consistent with protocols. Confirms completeness of info to be presented. Challenges conclusions when necessary. Independently resolves document content issues and questions
Maintains expert knowledge of US and international regulations, requirements and guidance associated with clinical regulatory document preparation and submissions. Advises teams regarding compliance with clinical regulatory document content as defined in journal/congress guidelines or regulations, respectively. Learns and applies knowledge of therapeutic area and product to projects. Must continually train/be compliant

132

Medical Writer Resume Examples & Samples

Writing, editing, formatting, and amending Investigator’s Brochures, clinical study protocols, Informed Consent Forms, and other clinical regulatory documents
Working independently to perform background research, writing and editing clinical and regulatory documents through draft, review, finalization and sign-off stages; summarizing data for FDA submissions, publications, and presentations
Acting as a technical lead in Medical Writing, adhering to appropriate format and style guidelines and ensuring high quality documentation with responsibility for ensuring proper Quality Control of documents produced
Achieving objectives by liaising with internal functional groups, such as data management, preclinical, regulatory affairs, and clinical research, as well as with external CRO’s
Familiarity with ICH E3 and GCP guidelines
Ensuring that all activities are conducted in compliance with any pertinent regulatory and statutory requirements and in accordance with scientific standards, ethical and professional values, established priorities, policies and practices of the company
Staying up-to-date with professional information and technology through independent study and conference attendance
BSc in a related life sciences discipline, Masters degree preferred, with a minimum of 5 years’ experience or an equivalent combination of education and experience
Medical writing experience in the biotech/pharmaceutical industry preferred
Excellent ability to organize and interpret materials for written documents, and a demonstrated track record of writing clinical documents
Ability to work effectively independently or as a part of a team
Comfortable managing multiple projects and ability to adapt to changing priorities
Excellent knowledge and ability with MS Office software; advanced user level in MS Word, Excel and Powerpoint
Strong understanding of clinical development

133

Principal Medical Writer Resume Examples & Samples

Serves as medical writing lead on more complex or clinical regulatory documents such as those associated with filings and dossiers. Works closely with the Publications or Regulatory team(s) on document strategies. Implements all activities related to the preparation of (e.g. abstracts, posters/oral presentations, manuscripts) or to the preparation and compilation of data and information into a single comprehensive package for new and updated clinicals
Converts relevant data and information into a form that meets clinical regulatory document requirements. Explains data in manner consistent with the target audience(s), journal/congress requirements, and/or clinical regulatory requirements. Coordinates the review, approval, and other appropriate functions involved in the production of scientific publishing or clinical regulatory projects. Arranges and conducts review meetings with the team. Ensures required documentation is obtained
Maintains expert knowledge of US and international regulations, requirements and guidance associated with clinical regulatory document preparation and submissions. Advises teams regarding compliance with clinical regulatory document content as defined in journal/congress guidelines or regulations, respectively. Learns and applies knowledge of therapeutic area and product to scientific publishing projects. Must continually train/be compliant
Serves as a department representative on project teams. Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments (e.g. eDocs, eCTD, journal/congress databases). Coaches, mentors, and assists medical writers. Provides guidance to non-Abbott medical writers and external vendors/agencies. Recommends, leads, and implements tactical process improvements, both within the department and division-wide

134

Senior Medical Writer Resume Examples & Samples

Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies
Researches, writes, edits complex clinical and scientific and program level documents, including IBs, INDs, and MAAs
Reviews routine documents prepared by junior team members. May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge
Ensures compliance with quality processes and requirements for assigned documents. Provides input on and independently develops best practices, methods and techniques for achieving optimal results, including various client-specific processes
May assist in program management activities. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications
Excellent oral and written communication skills with strong presentation skills
In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc
Great judgment and decision-making skills
Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)

135

Senior Medical Writer Resume Examples & Samples

A minimum of 5 years medical writing experience within the biopharmaceutical industry or a contract research organization
A solid understanding of the clinical development process, including the documents that are required at each stage
Excellent written, verbal and presentation skills
Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates
Prior experience with submissions in Common Technical Document (CTD) format

136

Associate Submission Medical Writer Resume Examples & Samples

Independently author submission documents and implement the submission authoring strategy under the leadership of GMW Strategist or Submission Medical Writer
Drive the design of all assigned project level submission documents in support of the Global Clinical Development Plan (CDP) under the leadership of GMW Strategist or Submission Medical Writer
Validate the individual study protocol design and clinical study report (CSR) key messages
Contribute to the project level data presentation strategy and messaging standards under the leadership of GMW Strategist or Submission Medical Writer
Mentor Senior Scientific Medical Writers and Scientific Medical Writers (internal and outsourced) in developing expertise in writing submission documents
Bachelor’s degree in natural sciences and a minimum of eight (8) years of experience or an advanced degree in natural science and a minimum of five (5) years of experience in the pharmaceutical industry
At least six (6) years of experience in regulatory medical writing, three (3) of which should be in writing the submission documents (Safety Summaries, Efficacy Summaries, Clinical Overviews, etc.)
Experience in developing clinical documents in support of regulatory submissions globally (ie multiple regions)
Thorough understanding of the overall drug development process
Specific knowledge of the research report development process, regulatory and drug safety requirements, and clinical data management and statistical processes/functions
In depth understanding of all regulatory guidance, standards and requirements pertaining to regulatory medical writing worldwide (eg ICH, FDA, EMEA)
Excellent working knowledge of current electronic authoring, document management and electronic regulatory submissions
Demonstrate strong communication skills, both written and verbal required to articulate concepts and ideas
PhD
Experience in supporting diverse therapeutic areas

137

Senior Medical Writer Resume Examples & Samples

Advanced degree is preferred
Additional qualifications in medical writing (AMWA, EMWA, or RAC)
Experience working in the pharmaceutical/contract research organization (CRO) industry is preferred

138

Medical Writer Resume Examples & Samples

Acts as Lead Medical Writer on most types of writing project, with guidance from senior staff as needed, and consistent high quality and efficiency
Arranges appropriate internal review of assigned documents and takes responsibility for on-time delivery. Identifies project needs, negotiates and tracks project timelines, and implements client requests with senior guidance
Offers proactive solutions and advice to customers as appropriate to experience, seeking guidance from senior staff as needed

139

Medical Writer Resume Examples & Samples

Produce high quality and timely communication materials (e.g., manuscripts, reports, abstracts)
Must be able to grasp quickly the objective of a study and the targeted messaging based on background materials provided (e.g., study report, manuscript outline)
Handle all aspects of a manuscript submission and follow up with journal editors; manage projects to ensure that authors respect deadlines and respond to comments promptly and effectively
Act as a resource to colleagues to help them improve their writing and data presentation skills in the development of tables, graphs and other material ultimately incorporated into client messaging documents

140

Senior Medical Writer, Early Phase Resume Examples & Samples

Compiles, writes, and edits medical writing deliverables and serves as Medical Writer on inter-department and intra-department project teams with moderate supervision. Provides medical writing deliverables covering primarily phase I research
Creates writing deliverables, under the guidance of the Research Scientist, that include, but may not be limited to
Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables
Adheres to established regulatory standards including, but not limited to, ICH-E3 guidelines, Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects on-time and on-budget
Performs on-line clinical literature searches as requested
Establishes and maintains the ‘medical writing’ standards for Clinical Pharmacology projects
Creates templates for various types of clinical documents
Reviews all writing of Clinical Pharmacology projects to ensure consistency and accuracy, a professional layout, and that all materials are updated as needed
Trains and supports the Clinical Pharmacology team in relevant aspects of pertinent software (e.g., MS Word, MS PowerPoint, Reference Manager, etc.)
Designs and prepares posters, brochures, slide presentations, etc. as required
Initiates and leads the copy editing and proofreading process for Clinical Pharmacology documentation in accordance with corporate Standard Operating Procedures
Prepares materials for presentation and publication
Communicates workload, resource needs, and priority issues with line manager and assists in resolving conflicts

141

Medical Writer Resume Examples & Samples

Support development of clinical submission documents, eg, CSRs, CTD summary documents (module 2.7), and Clinical Overviews (2.5); prepare and manage, create and/or review
May need to lead submissions or new programs
Respond to HA questions as needed (eg, prepare response documents)
Prepare IBs and other documents to support clinical programs
Any other related tasks as may be required, eg, review of documents and QC as needed
All services performed shall be in accordance with company SOPs/WPs
A contract medical writer may be assigned to one or more documents and may have a lead or supportive role

142

Trainee Medical Writer Resume Examples & Samples

Excellent interpersonal, verbal and written communication
A flexible attitude with respect to work assignments and training
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
Willingness to work in a matrix management environment and to value the importance of teamwork
Knowledge of Microsoft Office suite of programs

143

Associate Medical Writer Resume Examples & Samples

Knowledge of word processing, spreadsheet, database and e-mail applications required (MS Office and Adobe Acrobat recommended), with the ability to understand and adapt to various IT systems
Scientific background essential; at least two years’ experience in any discipline in the contract research, pharmaceutical or biotechnology industry (experience in the contract research environment preferred)
Bachelor's degree in Life Sciences/Health Related Sciences or equivalent

144

Medical Writer Resume Examples & Samples

Writing effective branded and unbranded medical copy targeted to a physician/healthcare professional (HCP) audience
Adapting and reviewing copy to suit various content template formats, including but not limited to: websites, interactive slide presentations, speaker videos, online graphic banner and text ads (multiple sizes), emails (including newsletters, formulary data, and/or safety alert-type communications)
Collaborating in creative brainstorms and internal reviews with graphic designers, account and marketing managers, web producers, product managers, editors, and others to accomplish project objectives
Providing vital support (including annotation work) to a client services team that helps brand managers and their medical/legal/regulatory (MLR) teams steer all promotional pieces through review and approval processes
Actively participating in meetings with clients (project kickoffs, status calls, etc.)
BA/BS, preferably in a scientific/medical discipline. Proven ability to write clinically sound, balanced copy with marketing finesse a must, even if you possess an MA/MS
4+ years’ relevant experience in a high-volume, process-oriented pharmaceutical advertising agency, medical education, or other healthcare communications writing role (focus should be on online promotional content development, preferably with some exposure to mobile environments)
Ability to absorb new therapeutic areas quickly
Demonstrated talent for teambuilding, particularly with Client Services-type (Account Managers), Web Services, and Editorial/Creative groups
Some understanding of pharmaceutical company MLR requirements and submission systems, FDA guidance, and/or OPDP regulations desired, but not required

145

Medical Writer Resume Examples & Samples

Writing effective promotional copy (branded and unbranded) targeted toward a physician/healthcare professional audience
Adapting and reviewing copy to suit various content template formats, including but not limited to: websites, interactive slide presentations, emails, speaker videos, online graphic banner and text ads (multiple sizes), etc
Collaborating in creative brainstorms and internal reviews with graphic designers, account and marketing managers, web producers, product managers, editors, and more
Providing vital support (including content strategy and annotation work) to a client services team that helps brand managers and their medical/legal/regulatory (MLR) teams steer all promotional pieces through review and approval processes
Troubleshooting strategic content- and process-related issues with other internal departments (including copyeditors, creative services, marketing personnel, etc.), as necessary
4+ years’ relevant experience in a high-volume, process-oriented pharmaceutical advertising agency, medical education, or other healthcare communications writing role (ideally, with a focus on online promotional content development, preferably with some exposure to mobile environments)
Demonstrated talent for teambuilding, particularly with account managers, web developers, designers, etc

146

Immunoscience Medical Writer Consultant Resume Examples & Samples

Writes, develops, fact checks, and edits content for deliverables, such as AMCP Dossiers, scientific presentations for payers, and responses to address specific unsolicited payer and Health Care Provider requests for health economic or outcomes information
Conduct literature searches in databases such as EMBASE and Pubmed/Medline
Analyzes and interprets scientific data to update or develop comprehensive, balanced, credible and accurate documents
Ensures deliverables that are developed to appropriately respond to inquiries from payers and Health Care Providers comply with applicable laws, regulations, guidance’s and policies and procedures
Maintains awareness of current industry practices that pertain to Medical Information
Complies with the reporting of adverse effects and product complaints to Worldwide Safety and Surveillance

147

Medical Writer Associate Resume Examples & Samples

Assist the managing editor of the journal with the daily operations of the journal including managing submissions, identifying reviewers, and submitting manuscripts for publication
Assist the managing editor with maintaining deadlines and coordinating the publication process, including communicating with editors, authors, and the publisher
Assist the managing editor with the maintaining a comprehensive database of all authors, manuscripts, and peer reviewers
Assist in the development of effective strategies for increasing journal promotion and growth, such as social media

148

Medical Writer Resume Examples & Samples

Adapting and reviewing copy to suit various content template formats, including but not limited to: websites, interactive slide presentations, speaker videos, online graphic banner and text ads (multiple sizes), emails (including newsletters, formulary-data, and/or safety alert-type communications)
BA/BS in English, Journalism, Communications, or some Medicine/Health-related field is preferred or equivalent years of professional experience
Proven ability to write clinically sound, balanced copy with marketing finesse a must, via writing sample
4+ years’ relevant writing experience in a high-volume, largely digital communications based writing role
Process-oriented pharmaceutical advertising agency, medical education, or other healthcare communications a plus
Experience targeting primarily non-US-based (global) physician/HCP audiences (focus should be on online promotional content development, preferably with some exposure to mobile environments) preferred
Bilingual English/, Spanish, or French, German or Portuguese language skills (reading, writing, and speaking in a professional medical communications capacity) are a plus
Some understanding of pharmaceutical company MLR requirements and submission systems, EMEA or FDA guidance, and/or OPDP regulations desired, but not required

149

Senior Principal Medical Writer Resume Examples & Samples

Serve as Medical Writing Lead for designated TA, working closely with the Clinical Leads, Clinical Scientists, other Clinical team members and Submission teams, as applicable, to gather the information (timelines; projects; documents) to forecast and budget resource needs for medical writing deliverables in Global branded R&D
Assemble and update the budget for medical writing deliverables in the assigned TA, with the support of the Senior Director, Medical Writing or designee
Review documents as Medical Writing Lead for programs within a designated TA
Serve as subject matter expert representing Medical Writing on cross-functional teams
Participate in selecting medical writers (primarily external). Train and mentor new staff and ensure staff adheres to Company systems and standards
Perform the Medical Writing review of selected documents from staff, contractors, or CROs, with focus on adherence to business objectives and Company standards, as well as organization of content, clarity of text and tables, overall consistency, and appropriate use of English language/grammar
Knowledge of clinical operations, health sciences and biostatistics is a plus working knowledge of document management system (eg, Documentum®)
Oral and written communication
Demonstrated ability to understand and represent data clearly in written text
Promoting innovation and process improvement
Assigning, reviewing, and planning medical writing assignments for in-house or contracted staff
Participating in performance evaluations
Professional leadership ability

150

Principal Medical Writer Scientific Publications & Planning Resume Examples & Samples

American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical
3 years of experience in experimental design and clinical/preclinical data interpretation preferred
Knowledge of biostatistics preferred

151

Principal Medical Writer Resume Examples & Samples

Supervise medical writing of other Medical Writers or contractors for assigned documents in the designated therapeutic area (TA)
Prepare high-quality clinical documents including clinical study reports, briefing books, clinical protocols, and integrated summaries for regulatory submissions
As Medical Writing Lead, responsible for quality and adherence to established timelines for all Medical Writing deliverables in the designated TA
An understanding of clinical drug development, clinical trials, and global regulatory submission regulations is desired
Proficient skills in Microsoft Word, Microsoft Excel, Microsoft Outlook, Adobe Acrobat are required
Skills in Microsoft PowerPoint, Microsoft Project, Microsoft Visio are a plus
Decision making, judgment, and problem solving
Initiative and accountability
Implementing and facilitating adherence to processes
Maintaining and coordinating medical writing activities
Participating in the selection and training of new employees
Interpersonal relationships, team building, motivating employees, and influencing others
Developing people and staffing

152

Oncology Medical Writer Resume Examples & Samples

Develop and update biomarker medical communication content per clinical development program, publications, data releases, congress activity, customer inquiry trends, treatment landscape, market events, etc
Conduct literature searches, author medical communications content and perform data accuracy reviews for medical communications content on BMS oncology assets
Literature search: identify and review all relevant data available in published literature to ensure in-depth and relevant medical data is reflected in all deliverables
Medical writing: author medical standard responses, Q&As, slide decks, and training materials that are succinct and scientifically rigorous
Data accuracy review: perform data accuracy reviews of all deliverables to ensure all content is supported by available data/references
Support development of biomarker/translational medicine training deliverables on disease state, product overviews, and relevant market events to ensure readiness to address customer inquiries
Consistently maintain in-depth knowledge of oncology, biomarker and evolving competitive landscape

153

Senior Medical Writer Resume Examples & Samples

Perform comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies; staying informed about applicable clinical landscapes and trends
Write and edit CERs, Clinical Summaries, including special summaries from raw data for submission to regulatory agencies, adverse event narratives, comprehensive reviews, and other projects requiring skills in medical communication including but not limited to CSRs, protocols, abstracts, manuscripts, white papers, publications, IBs, integrated summary documents, clinical portions of INDs, NDAs and ANDAs as well as SOPs
Lead cross functional coordination in order to manage medical writing deliverables
Ensure appropriate communication on project-related matters within the project teams as it relates to medical writing deliverables
Establish working relationships within Quality Assurance and divisions to ensure client satisfaction of medical writing deliverables
Ensure document content and style adheres to Good Clinical Practice (GCP), International Conference of Harmonization (ICH) or other appropriate regulatory guidelines and complies with SOPs
Attend and participate in Risk Analysis meetings for all divisions. May participate in audits
Define and manage medical writing resource needs and establish contingency plans for key resources for assigned projects
Initiate and participate in process improvements to templates and SOPs to enhance the efficiency and the quality of the medical writing work performed on assigned projects
Accountable for developing and incorporating in-depth knowledge of product areas, current developments in the field, and of current literature
Bachelor’s degree and at least 4 years’ experience developing/writing medical documents such as: Clinical Evaluation Reports (CERs), Investigator Brochures (IBs), protocol synopses and protocols, literature reviews, clinical study reports (CSR), narratives, integrated summary documents, clinical portions of INDs, NDAs, ANDAs (eCTD modules) as well as SOPs

154

Medical Writer Resume Examples & Samples

Responsible for the creation and oversight of project plans, which includes timeline management, preparation of business-critical regulatory documents, and the quality of key deliverables
Independently produces high quality, medically accurate analyses of clinical and post-marketing data for internal and external customers in written format under the direction of the Senior Medical Writer
Critically reviews and edits the analyses of the Scientific Writer, assuring that documents are of the highest quality, appropriate for the designated audience, and reflect current medical standards
Performs job responsibilities in collaboration with the Senior Medical Writer, Medical Safety Experts, management, and cross-functional areas within Medical Affairs, Regulatory Affairs, Clinical Development and the Product Safety Teams
Expert on applicable writing styles and standards, ensuring deliverables meet organizational, regulatory, and customer needs
Utilizes a variety of resources to support conclusions/assumptions and demonstrates sound medical judgment regarding causality based on the application of clinical experience, standards of care, and regulatory guidelines
Actively contributes to minimizing patient and product risk by conducting pharmaceutical and medical assessment of information on drug risks including adverse reactions, drug interactions, toxicity and medication errors during periodic report preparation. This includes the consideration if safety data qualify as a new safety signal or as a new identified or potential risk, or may potentially alter any previous signal or risk assessments
Proactively understands regulatory framework, trends & requirements related to Pharmacovigilance, clinical studies and global drug development
Is accountable for the timely preparation of assigned periodic reports
Requires some oversight/guidance
Minimum 3 years industry experience in Pharmacovigilance, Strategic Medical Affairs or Clinical Development
Understanding and initial experience in Pharmacovigilance in the pharmaceutical industry or academia or equivalent
Understanding of medical conditions and disease state entities, able to critically evaluate medical data
Experience in preparation of periodic safety reports
Experienced professional operating within the international arena, and working across functional areas
Proficiency in the use of Microsoft Excel, Word, Power Point, Outlook, e-room technology, and good electronic Common Technical Document (eCTD) knowledge and formatting skills (e.g. ISI Writer)
Very good communication and presentation skills (oral and in writing) in English

155

Senior Medical Writer / Project Manager Resume Examples & Samples

Function as a key contributor in planning & preparation of high quality documents ensuring adherence to GCP, ICH guidelines, and Alkermes SOPs
Coordinate and oversee MW service providers
Manage document reviews, version control and timelines with CROs and other medical writing consultants/contractors
Assist in technical preparation of eSubmission ready documents
Engage in background research related to documents in development
Collaborate with various functional areas in Clinical Development and Medical Affairs, Regulatory, and Project Management in planning and preparation, and review of clinical and regulatory documents
Stay current on medical writing best practices and regulatory guidelines
Actively participate and contribute to the strategic development of assigned projects
Represent Medical Writing on study teams/clinical teams
B.S. in a relevant scientific field preferred
3+ years of industry experience as Medical Writer or Medical Writing Operations
Experience in clinical regulatory documents
Experience working with standard document templates/styles to support electronic (eCTD) submissions
Proficient with MS Office, MS Project and other related software programs
Advanced degree (M.S. or Ph.D.) in a relevant scientific field
Ability to plan ahead and engage others to meet deliverables
Experience in psychiatry/ neurology/cardiovascular/ analgesic therapeutic areas

156

Assoc Scientific Medical Writer Resume Examples & Samples

Act as the medical writing expert responsible for managing and editing study level documents (clinical study protocols and clinical study reports) in the area of Oncology
Independently author parts of study level documents (collaborating with the team)
Implement content strategy, project level data presentation and messaging standards as provided for the assigned documents
Be accountable for the format, content and adherence to global and electronic publishing standards of the individual clinical documents
M.Sc. or similar
Two (2) years of experience in regulatory medical writing in the pharmaceutical industry
Familiar with all regulatory guidance, standards and requirements pertaining to regulatory medical writing worldwide (e.g. ICH, FDA, EMEA)
Basic understanding of the drug development process
Working knowledge of the clinical study report and development process, regulatory and drug safety requirements, clinical data management as well as statistical processes/functions
Strong communication skills in English, both written and verbal, to successfully articulate concepts and ideas
Must be diplomatic, persuasive and able to establish rapport with all key functional interfaces and experts in the Oncology Development organization

157

Medical Writer Resume Examples & Samples

Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, and informed consent forms
Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures and periodic safety reports (PSURs, DSURs, etc.)
Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes
Other tasks as assigned
Proficient in Microsoft Word (including the use of templates), Excel, and PowerPoint
Experienced with scanners, printers, and copiers

158

Associate Medical Writer Resume Examples & Samples

Writing effective branded and unbranded medical and CPG copy targeted to a consumer/patient audience
Adapting and reviewing copy to suit various content template formats, including but not limited to: websites, interactive slide presentations, speaker videos, online graphic banner and text ads (multiple sizes), emails
Collaborating in creative brainstorms, client status calls, and internal reviews with graphic designers, account and marketing managers, copywriters, editors, and others
Providing vital support (including annotation work, if/when necessary) to a client services team that helps brand managers and their medical/legal/regulatory (MLR) teams steer all promotional pieces through review and approval processes
BA/BS, preferably in a scientific, medical, or healthcare-related field
Solid communication, client-facing, project/time management, and computer skills (MS Office Suite, Adobe Acrobat Pro, electronic workflow management systems, etc.)
Ability to comprehend clinical information, branded master visual aids, and/or online interactive programs; science background a plus
Demonstrated talent for teambuilding
2+ years’ relevant experience in a high-volume, online pharmaceutical advertising agency, medical education, or other healthcare communications writing role is preferred, but not required

159

Principal Medical Writer Resume Examples & Samples

LI-LC1
Bachelor's degree in a science-related field
Prior experience within medical writing
Prior experience in managing and directing complex medical writing projects
Additional qualifications in medical writing (AMWA, RAC, etc) is advantageous
Broad regulatory affairs experience is an advantage
Advanced degree (PharmD, PhD, Masters) is preferred
Suitable, relevant experience working in the pharmaceutical/CRO industry is preferred
Excellent interpersonal skills including problem solving
Advanced word processing, template and document management skills
Excellent understanding of computers and their applications
Attention to detail and quality of document
Good and effective organizational and planning skills
Self-motivated and adaptable
Able to multitask
Able to plan own work well in advance
Able to work on own initiative
Proven ability to work effectively in a team
Able to teach/mentor team members
Able to motivate and integrate teams
Mental skills required in areas of: Numeracy, Language, Analytical, Investigative, verbal & written communication, Attention to detail, Customer contact, Multiple project handling, Reading and interpretation of data
Excellent knowledge of Global Regulatory Affairs Procedures
Good knowledge of global / regional / national document development requirements
Excellent knowledge of relevant ICH and other global regulatory and document development guidelines
Good in-depth knowledge in a specialty area; preclinical, therapeutic, regulatory, submissions, communication, etc
Able to manage and plan multiple complex projects
Able to direct the work of others
Excellent judgment and decision-making skills
Able to act as liaison with other Divisions where necessary (i.e., Project Management, Clinical Supplies, QA, Clinical Management, Data Management, Biostatistics, Late Stage, etc)
Knowledge of budgeting and forecasting

160

Healthcare Solutions Principal Amcp Medical Writer Resume Examples & Samples

Responsible for but not limited to: developing, editing and managing the production of AMCP Dossiers and scientific presentations for payers
Collaborate with therapeutic area leads to incorporate TA strategies, scientific platforms, value messages into AMCP dossier
Collaborate with Global Medical Information to develop and/or edit responses to address specific unsolicited payer and health care provider requests for health outcome information
Analyze and interpret scientific data to update or develop comprehensive, balanced, credible and accurate documents that comply with applicable laws, regulations, guidance’s and policies and procedures, and are used to appropriately respond to inquiries from payers and health care providers
Provide medical writing support for multiple assets within a therapeutic area(s)
Perform literature searches for drafting AMCP dossiers
Understand, assimilate, and interpret sources of information with appropriate guidance/direction from team members. Interpret and explain data generated from a variety of sources, including internal and external studies, research documentation, charts, graphs, and tables, and verify the results are consistent with study data
Identify and propose solutions to resolve issues and questions arising during the writing/review process, including resolution or elevation as appropriate
Maintains awareness of current industry practices that pertain to Corporate Policies and Procedures. Must continually train/be compliant with all current industry and company requirements
Complies with the reporting of adverse effects and product complaints to Pharmacovigilance and Surveillance

161

Senior Medical Writer Resume Examples & Samples

As a member of staff, you will be expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs
You will independently write clinical study reports and other regulatory documents according to ICON or client-specified formats
You will be responsible for writing patient narratives independently for serious adverse events and drop-outs due to non‑serious adverse events
You will have to independently provide additional writing and editing services (e.g. for publications) as required
You will need to Advise on the content and format requirements for clinical reports and regulatory documents
You will be performing quality control (review) of documents and assess whether specific project related documents comply with regulatory requirements, client requests and ICON SOPs
You will independently interact with clients to obtain necessary and relevant information and deal with queries through effective decision making
You will participate in non-project specific activities, including assistance in maintaining the medical writing work schedule
You will participate in the training and supervision of new and junior medical writers
You will assist Business Development team with the preparation of proposals and cost estimates for medical writing tasks

162

Senior Medical Writer Resume Examples & Samples

Mentors junior writers on departmental processes related to document preparation (e.g., planning document-related meetings, developing document timelines); reviews documents written by junior writers for content and format
Participates on departmental initiatives
LI-SRC6

163

Principal Medical Writer Resume Examples & Samples

Knowledge of team dynamics and ability to function as a team leaderPHYSICAL DEMANDS
Manual dexterity required to operate office equipment (i.e. computers, phones, etc.)
Carrying, handling and reaching for objects

164

Medical Writer Resume Examples & Samples

You will be responsible for developing clinical, regulatory and educational documents such as study reports, Instructions for Use, protocols, abstracts, manuscripts, posters, presentations and press releases
The development process includes writing, interpreting and summarizing clinical and non-clinical data, compiling information, and ensuring delivery within timelines
You develop content that meets the stated objectives of the project, is scientifically and medically accurate; and follows house style guides and procedures
You work closely with R&D in order to deliver high-quality documents

165

Medical Writer Resume Examples & Samples

Be primary author for documents that are within scope, which includes, but is not limited to: clinical study protocols, ICF, CSR, IB, PBRER/DSUR, committee charters, sections for regulatory submissions, CMC – internal protocols and reports and manuscripts
Establish a business process for liaising with other departments (including but not limited to Data Management, Program Heads, Regulatory, Safety) to gather data for the above mentioned reports
Develop and maintain tracking for the above mentioned documents
Develop and standardize templates used in the writing of Clinical and other submission documents
Create and update SOPs as needed
Assist in writing technical reports, regulatory briefing documents and other documents to support product development
Establish a style guide
Prepare presentations as needed
Experience within a broad range of medical writing projects
Good knowledge of global / regional Medical Writing / Regulatory Affairs for clinical trials, marketing authorization and late phase procedures
Additional qualification in medical writing (e.g. American Medical Writers Association) is advantageous
Proficiency with Microsoft Office, in particular Word, Excel and PowerPoint

166

Medical Writer Resume Examples & Samples

Write documents associated with the independent review including, but not limited to: independent review charters (IRC), reviewer manuals, imaging case report forms (CRFs)
Lead the internal and external project team through the development of documents associated with the independent review
Coordinate and conduct interdivisional team review and sign-off of document deliverables according to PAREXEL’s guidelines/SOPs, including distributing drafts, chairing round table meetings, incorporating revisions, and completing the sign-off procedures
Meet client expectations by following any templates, style guides, or SOPs provided by the client for document development (within the appropriate regulatory guidelines)
Regularly communicate project-related issues with the Manager, Medical Writing, and the project team, as appropriate
Maintain a positive, results-orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner
Bachelor’s degree in Life Sciences/Health Related Sciences recommended
Clinical research/medical writing experience and 1-3 years medical writing experience in a contract research organization, or 2-4 years of experience in a pharmaceutical or biotechnology firm, or equivalent
Excellent written and oral communication and interpersonal skills
Strong word processing and Microsoft Office Suite skills: advanced skills in Microsoft Word and proficiency in Excel and PowerPoint
Excellent organizational skills to work with the vast array of information gathered during document development and to cope with rapidly changing information
Knowledge of the drug development process essential
Knowledge of GCP/ICH guidelines and the clinical trials process

167

Medical Writer Resume Examples & Samples

Build understanding of the literature and current medical opinion
Support the teams regarding new clinical data or medical press coverage
Plan and conduct of fair-balanced assessment of efficacy and safety data and provide advice on the best approach to drive brand growth
Assist in registration and development of RB Global products globally
Serve as a technical point of contact for governance activities and collaborate with cross-functional teams
Provide medical support and oversight for promotional activities
Support the writing, editing and reviewing of diverse Regulatory and Clinical Documents required for global RB product development and registration activities. These include but are not limited to: briefing documents, common technical document (CTD) clinical overviews and summaries, switch applications, integrated summaries of safety and efficacy, clinical evaluation reports and other Medical/Regulatory documents
Edit and proof reading of text written by other team members and providing constructive feedback
Help create and maintain audit system/trails of all document changes
Prepare responses to Medical Information requests where appropriate

168

Senior Medical Writer Resume Examples & Samples

This role predominantly focuses on writing, editing and reviewing regulatory (e.g. Clinical Evaluation Reports/clinical study reports/summaries) documents and responses to Notified Bodies
Post Market Surveillance activities (monthly literature review of our product)
Scientific Writing e.g. abstracts, manuscripts, presentations
Requires a strategic understanding of the therapeutic areas, business and study objectives as well as statistical data
Independently, critically writes and edits scientifically complex documents for substantial intellectual content
Reviews and provides input on the data being considered for publication to ensure alignment with current medical issues and corporate goals
Expert knowledge of clinical research, device/drug development processes, regulatory requirements, and good clinical practices
Ability to understand and interpret statistical results of clinical studies; ability to summarize complex results and present them in a clear, concise, and scientifically accurate manner to a wide range of audiences
Clinical, scientific or research background
Ph.D./Pharm.D plus 3+ years of related pharmaceutical/medical device industry experience

169

Senior Medical Writer Resume Examples & Samples

2+ years relevant experience
Demonstrated scientific writing ability
Strong communication/presentation skills
Works well in cross-functional teams and promotes team alignment
Expert understanding of scientific or clinical research and the scientific method
Ability to critically analyze and interpret scientific data
Highly proficient in the use of Microsoft Office suite (Microsoft Word, PowerPoint, Excel), Adobe software (Photoshop, Illustrator), and EndNote Reference Software
Adept in performing literature searches in Pubmed and other relevant platforms
Understanding of statistical methods
Can proactively and independently communicate throughout the organization
Ability to adapt to changes rapidly in a fast-paced working environment
Able to identify problems and propose potential solutions
Ability to coordinate and prioritize multiple projects simultaneously with minimal supervision
Can identify and lead departmental initiatives

170

Senior Medical Writer Resume Examples & Samples

Bachelor's degree in a technical discipline
5+ years’ experience supporting clinical research and report writing or experience writing in a medical/scientific area
Masters or PhD degree(s) in biomedical sciences or technical disciplines
Medical device industry experience or related industry experience
Direct experience with medical and/or scientific writing within a medical device industry or related industry including preparation of Clinical evaluation reports and post market surveillance reporting
Computer skills (Microsoft Word, Excel and Project or equivalent)
Database management experience in the Administrator capacity (Quosa, Microsoft Access or equivalent)
Experience conducting literature searches and literature reviews
Experience managing Endnote Libraries
While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers

171

Senior Medical Writer Resume Examples & Samples

Draft clinical & scientific documents including but not limited to, clinical evaluation reports, clinical risk benefit analysis, interim and final clinical study reports for the assigned projects
Coordinate and manage review processes, revise the documents as per comments from internal & external reviewers, and lead discussions on document revision and finalization
Conduct literature searches, manage the literature database and prepare literature reviews for external and internal clients
Participate in the periodic reviews of recent scientific publications and online content relevant to the business; draft article summaries for distribution to key stakeholders
Attend major national & international conferences to keep up to date with advancements in the field; contribute to the development of conference coverage reports for internal distribution
Develop and maintain SOPs and writing tools, such as templates and style manuals
Advanced degree in a scientific discipline (Master's degree, Ph.D., MD) with 3+ years’ experience in the medical device/pharmaceutical field with an Advanced degree, or a minimum of 7 years with a Bachelor's degree
Experience in the development of clinical, scientific, and regulatory documents
Demonstrated ability to meet project goals within a matrix environment

172

Med Info & Medical Writer Positions for Med Device Professionals Resume Examples & Samples

BA, BS, or BSN is required; advanced degree is preferred
Minimum of 3 years of related job experience
Experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements
Strong oral communication, presentation, project management and prioritization skills
Excellent interpersonal relationships
Highly proficient in Microsoft Office Suite and bibliographic software (e.g. Endnote, Reference Manager)
benefits to be received upon meeting eligibility requirements

173

Clinical Medical Writer Resume Examples & Samples

Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports
Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
Adheres to departmental procedures and practices and technical and industry standards during all aspects of work
Assists in developing and reviewing standard processes and templates within Clinical Medical Writing, and may also review/consult on the development of standard processes and templates in other departments
Works effectively with cross-functional groups within BioMarin
At least 6 years of medical or scientific writing experience as a primary job responsibility, including at least 3 years as a clinical or regulatory medical writer in the pharmaceutical industry
Familiarity with the drug development process (discovery to market), clinical study protocol design and study conduct, documentation required for the conduct of clinical studies, and clinical study data collection and results reporting
Advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documetns and templates
Experience writing protocols and clinical study reports. Review and/or editing experience alone is not sufficient
Ability to interpret and summarize tabular and graphical data presentations
Proficient in the use of Windows-based office applications. Extensive experience in Microsoft Word (including the use of templates)
Capable of working on multiple tasks and shifting priorities, and capable of leading cross-functional teams under strict timelines, including calling/running meetings and managing review/adjudication of documents
At least 10 years of medical or scientific writing experience as a primary job responsibility, including at least 5 years as a clinical or regulatory medical writer in the pharmaceutical industry
Experience writing BLA/MAA submissions (Module 2 and 5 documents), IND/CTA submissions, investigator's brochures, periodic safety reports, and informed consent documents
Experience working with Adobe Acrobat (creating and editing PDF files). Experience with Acrobat Reader is not sufficient
Intermediate/Advanced applied knowledge of AMA and Chicago Style Manuals
Some knowledge of basic clinical laboratory tests, including their purpose in diagnosing disease
Some knowledge of regulatory requirements and guidances associated with ‘standalone’ regulatory documents (eg, protocols, investigator brochures, and clinical study reports)
Good conflict management skills, including ability to broker agreements between disagreeing parties
Motivated and detail oriented

174

Senior Medical Writer Resume Examples & Samples

Planning and coordination of timelines, meetings, and facilitation of cross-functional communication and contribution
Assisting with responses to questions from regulatory authorities (eg, MAA and FDA)
Contribute to regulatory submissions by authoring relevant sections of eCTDs (eg, ISS, Summary of Clinical Safety)
Performing quality-checks of documents for agreement between in-text and source data
Editorial review of documents, including submission-compliant formatting
The candidate must be able to work independently and efficiently with cross‑functional team members. Reliance on instructions, templates, and pre-established SOPs and guidelines will be expected to perform the above functions

175

Expert Medical Writer Resume Examples & Samples

Act as a member of clinical trial teams and submission teams and autonomously write/edit clinical study reports, CTD summary and overview documents, other regulatory documents (e.g. RMPs, Briefing books etc)
Provide authoritative guidance to other line units and within RMW with respect to regulatory submission documents and other document-related issues
As requested by RMW management, act as lead writer and co-ordinate production of documents by medical writing team in collaboration with clinical team
Write/edit other strategic documents, as required, in collaboration with project teams and where necessary, with support from Senior Expert Medical Writers or RMW leadership team members
Contribute to development of document templates and processes both within RMW and more widely
Act as mentor to other medical writers
At least 4 years medical writing experience or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge, plus strong knowledge of medical writing processes

176

Medical Writer Resume Examples & Samples

Ability to act as the editorial and scientific point of contact for multiple accounts in a variety of therapy areas
Lead a variety of projects from client brief through to delivery on time and within budget
Deliver high-quality educational and creative promotional materials
Ensure materials are adapted to the briefed target audience
Provide in-house editorial review of work undertaken by freelancers and junior writers
Liaise directly with clients to fulfil their communication and marketing objectives
Participate in client teleconferences and meetings as required
Participate in the cross checking of editorial work written by other members of the writing team
Support in winning new business through pitch research and presentation
Taking the lead where appropriate in scientific and creative discussions around content
Independently research and write sales aids, leave pieces, advertisements and training materials for pharmaceutical and device clients
Ability to work on materials delivered via digital communications platforms in conjunction with the digital part of the business (idetails, apps, web copy)
Previous experience of medical writing within an agency environment (1-2 years minimum)
Able to seek out, critically appraise and appropriately cite published information
Sound understanding of scientific/pharmacologic principles and mechanisms of action
Experience writing web copy and promotional materials for pharmaceutical clients
Sound knowledge of the codes of practice for the pharmaceutical industry
Relevant Life Sciences qualification

177

Senior Medical Writer Resume Examples & Samples

Responsible for writing up the final project deliverables. These deliverables will be concise and easy to read, incorporating the analysis plan, analytic results, and a review of the literature. The deliverables may be in the form of internal reports, slide decks, or peer reviewed publications
Create abstracts, posters, and podium presentations for national conferences
Report to the Senior Director, Advanced Analytics at Optum
Post-graduate degree in a related field plus some relevant experience in the insurance industry
3+ years of experience in medical writing
Able to understand and present data correctly, clearly, and concisely in a variety of media
Knowledge of research / policy regarding the elderly and near elderly
Able to work collaboratively as well as independently to produce high quality deliverables within specified timeframe
Able to conduct multiple projects concurrently
Proficiency with Microsoft Office applications essential
Excellent writing and editing skills
Outstanding analytic and problem-solving skills; demonstrated self-motivation, sound judgment, and attention to detail
Graphic Design experience

178

Medical Writer Resume Examples & Samples

Provide medical/clinical expertise related to PD, HD, and/or CRRT therapies and related products including their clinical use and potential mis-use to internal cross functional teams
Prepare clinical response to government authorities, in conjunction with regulatory and medical review, to ensure questions around renal therapy are interpreted correctly
Develops clinical documents ensuring scientific excellence. The development process includes writing, interpreting and/or summarizing clinical and non-clinical data, compiling information, leading team meetings, and ensuring delivery within timelines. Clinical documents may include investigator brochures, clinical study reports, integrated reports, Clinical Investigation Reports, new product submissions. May also review case report forms and statistical analysis plans, product labels, and responses to regulatory agency inquiries
Maintain current familiarity with the published medical literature related to the renal product lines so that information can be incorporated into various documents created within the organization in compliance with regulations around the world
Possess and understanding and maintain current knowledge of regulatory and quality requirements
Develop/review annual safety documents (such as PBRER, PSUR, CER, RMPs) and labeling products
Responsible for the coordination, preparation and/or completion of clinical sections of renal therapy-related risk file updates, CCSI or label updates, and other documents as assigned
Develop and review quality related documents as they pertain to our products
Provide clinical support of complaint and adverse event analyses
Assist Baxter's Regulatory Affairs by providing clinical input into the evaluation and response of Ministry of Health (MOH) queries
Develop expert knowledge on all Baxter/Gambro Renal products
Interface with other Baxter functional groups such as Medical Affairs, Regulatory Affairs, Quality, and global business units, as needed
Work with team to define project deadlines and monitor project progress to ensure that documents required to support regulatory filings are submitted on time to regulatory authorities
Lead or participate in project teams and committees as assigned
Ensure compliance of all related clinical documents with national and international regulatory requirements and guidelines and Baxter procedures (as applicable). Includes collaborating with medical editors to ensure documents are publication-ready across functional teams

179

Medical Writer Resume Examples & Samples

Serve as medical writing lead for clinical trial-related regulatory documents
Write/edit/review content of clinical trial-associated documents for new and ongoing programs
Work with cross-functional teams to ensure production of high-quality written documents
Perform literature searches as needed, and summarize data for incorporation into documents
Adhere to Kite Style Guide, templates, and SOPs for document development
Perform QC checks on document content
Commit to company timelines for all assigned documents

180

Scribe / Medical Writer Resume Examples & Samples

Accommodates the needs of the patient for the exam
At times, guides patient to front desk after completion of exam and ensures proper follow-up appointments are made
Correctly summarizes and documents what the physician says during an examination, including but not limited to: proper charting of the examination, documenting additions to the chief complaint, assessment and recommendations for treatment (including justifications of decisions reached when appropriate)
Enter charge information as designated by the physician
Evaluates the condition of the exam room to ensure adequate supplies are in stock
Learns the personality and preferences of each physician, recognizing differences and abiding by them when working with each particular physician
Maintains an awareness of the patient�s verbal and non-verbal communication when the physician is providing instructions as it may necessitate the writer repeating information, providing written instructions, and/or patient educations materials for the patient to review at home
Monitors examination room and any physical limitations that the patient may have
Notifies physician of changes to the daily schedule, especially emergencies
Performs other duties as assigned, including but not limited to, answering phones, scanning, abstracting, checking patients in and out, helping with work ques, etc
Provides patient with assistants while they are exiting the exam room to expedite patient flow
Remains as close to physician as possible and limits time away from the physician and the patient
Fluency in English High School Diploma and four years experience in a medical office, medical transcription or billing/coding required Or Associates degree or equivalent and two years experience in a medical office, medical transcription or billing/coding required
Basic of knowledge ICD-10 coding
Act 33 Child Clearance with Renewal
Act 34 Criminal Clearance with Renewal
Act 73 FBI Clearance
Basic Life Support or Cardio Pulmonary Resuscitation

181

Medical Writer Resume Examples & Samples

Work with lab members to draft and edit scientific articles and shepherd them to publication
Assist in planning, writing, editing, and submission of grant proposals and progress reports
Prepare scientific illustrations; assemble and organize data into figures for scientific presentations, publications, and grant applications
Research and develop materials for presentations at scientific conferences, public outreach seminars, leadership meetings, and fundraising opportunities
Attend meetings and manage scientific communications with collaborators
Participate in weekly lab meetings and scientific discussions
Other communications duties as required

182

Contract Medical Writer Resume Examples & Samples

Advanced degree (MS or Ph.D.) in a relevant scientific field preferred
3+ years of industry experience as Medical Writer
Experience in psychiatry/ neurology/cardiovascular/ analgesic therapeutic areas is a plus
Experience in clinical documents related to late phase studies, IB, IND, Annual Reports
Ability to work independently and collectively on teams
Ability to plan ahead and engage others to meet deliverable

183

Senior Medical Writer Resume Examples & Samples

Draft high-quality clinical & regulatory documents that demonstrate a good grasp of the scientific and medical content and drug development process with excellent understanding of data analysis, data management and regulatory submissions
Work across departments to help set priorities for document preparation and collaborate on document content
Coordinate and manage consulting writers as needed
Work with service providers as needed for delivery of high quality documents
Write clinical abstracts, posters, and manuscripts
Review and edit documents prepared by other authors
Maintain document history and manage version control of documents
Provide guidance for style guides for document preparation
Keep current with relevant therapeutic area(s)

184

Cr-medical Writer Resume Examples & Samples

Writes and oversees the preparation of clinical study protocols, clinical study reports, Investigator’s Brochures, clinical pharmacology sections of US and EU clinical trial applications and marketing applications, and other high-level summary, briefing, and response documents in accordance with international guidelines
Develops/Maintains standards and processes
Follows Teva Safety, Health, and Environmental policies and procedures

185

Cr-medical Writer Resume Examples & Samples

Working knowledge of regulatory document submission standards and guidance documents related to electronic documents for submissions
Advanced Microsoft Word and Adobe Acrobat skills strongly preferred
Experience with Documentum
Previous use of ISI Toolbox
One to three years of related experience
) Strong understanding of eCTD Clinical documents
)Team Player
) ability to take direction and them work independently
) experience with documentum

186

Principal Medical Writer Resume Examples & Samples

Serves as medical writing lead on more complex scientific publications or clinical regulatory documents such as those associated with filings and dossiers. Works closely with the Publications or Regulatory team(s) on document strategies. Implements all activities related to the preparation of scientific publications (e.g. abstracts, posters/oral presentations, manuscripts) or to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical
Responsible for effective communication among team members. Communicates deliverables needed, writing process, and timelines to team members. Holds team members accountable to agreed-upon project dates. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.). Must identify and resolve conflicts (including document content issues), remove barriers, generate innovative ways to ensure teams achieve project goals. Ensures all
Maintains expert knowledge of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions. Advises teams regarding compliance with scientific publications or clinical regulatory document content as defined in journal/congress guidelines or regulations, respectively. Learns and applies knowledge of therapeutic area and product to scientific publishing projects. Must continually train/be compliant
Bachelor of Science required, with significant relevant writing experience, or Bachelor's degree in English or communications, with significant relevant science experience. Masters or PhD in science discipline preferred with relevant writing experience
4 years relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/R&D
2 years relevant industry experience preferred
4 years experience in experimental design and clinical/preclinical data interpretation preferred
High-level content writing experience and experience with all types of clinical publications or clinical regulatory documents required. Expert in assimilation and interpretation of scientific content with adeptness in ability to translate for appropriate audience. Working knowledge of statistical concepts and techniques
Expert knowledge of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions and ability to advise teams regarding compliance with regulations. Knowledge and expertise with Common Technical Document content templates. Expert knowledge of current electronic document management systems and information technology
Excellent written and oral communication skills. Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy
Extensive experience in working with collaborative, cross-functional teams, including project management experience

187

Report Coordinator, / Medical Writer Resume Examples & Samples

Must be highly proficient in Microsoft Word and Excel, and have excellent oral and written communication skills. Experience with other software applications such as Adobe Acrobat and MS Access are a plus
The ability to multitask and manage a flexible project load is mandatory
Strong interpersonal, time management and organizational skills are also required
At the time of interview, an assessment of skills to determine levels of proficiency with Word, Excel and editing will be given
Editing experience is a plus

188

Medical Writer Resume Examples & Samples

Write clinical study reports under supervision of more experienced writers
Write patient narratives autonomously
Quality check patient narratives written by other writers
Write safety documents (e.g. RMP, DSUR) under supervision from more experienced medical writer
Act as a member of clinical trial teams following protocol finalization
Participate in planning of analysis and data presentation to be used in study reports, initially in conjunction with mentoring medical writer
Preparation of narratives, clinical study reports and (as required) other regulatory documents with respect to timelines and compliance to internal and external standards
Completion of an adequate number of clinical documents (taking into account complexity) per year
Adequate representation of RMW in the clinical trial team
Basic knowledge of statistics, basic data interpretation and presentation skills
Good document creation and editing skills
Basic knowledge of clinical documentation
Basic knowledge of drug development

189

Medical Writer Resume Examples & Samples

Taking and accurately interpreting briefs from clients and other members of the BioScience team
Responsibility for the management and development of a range of editorial materials such as publications, meeting materials, slide kits and electronic materials, including researching, writing and editing, with little input from more senior members of the editorial team
Delivery of materials within timelines and budgets, including problem solving
Managing the development of the design process for editorial materials, in conjunction with account staff
Provide direction for the development of creative designs
Attendance at onsite meetings providing a variety of support, including slide reviews, faculty support, AV production and general assistance
Being the day-to-day contact for clients in relation to specific medium to large sized editorial projects or editorial lead on small accounts that the writer is responsible for
Implementation of specific client or in-house styles
Contributing to the development of new business proposals and pitches, where appropriate
Keeping abreast of new developments within the field of medical education and passing on of knowledge to the internal team and external clients, where appropriate
Adherence to deadlines and budgets
Life sciences qualification
Demonstrable competence in scientific and commercial writing with ability to adapt to different target audiences and styles
Previous experience of working within a Medical Communications agency or similar role
Knowledge of publications planning and experience of writing manuscripts
Attention to detail and scientific accuracy
Excellent time management and project organisational skills
Ability to adapt quickly to a wide range of therapy areas
Proficiency in Microsoft Word and PowerPoint. Previous experience of referencing software is preferable

190

Medical Writer Resume Examples & Samples

Minimum of a BA/BS in Life Science
3-5 years pharmaceutical/biotechnology experience related to clinical research
Demonstrated expertise in writing/developing clinical documents in support of regulatory submissions globally Ability to interpret and organize scientific and clinical data
3+ years medical writing experience in Pharma, Biotech and/or CRO, necessary
Experience with ICH and electronic submission guidelines for regulatory reports
Good leadership, communication, and influencing skills
Ability to collaborate with a wide variety of internal customers and relate effectively to people at all levels of the organization
Ability to manage change successfully and identify process improvements
Applies good judgment and demonstrates initiative to resolve issues
Excellent computer skills including MS Office (Word, Excel, Power Point, Outlook)
Ability to enact change and foster an innovative atmosphere

191

Medical Writer Resume Examples & Samples

Write clinical protocols, clinical study reports, investigator’s brochures, annual reports, INDs, IMPDs, and NDAs and other regulatory documents in conjunction with the project team with minimal supervision
Write, review, and/or edit publications (manuscripts, abstracts, poster presentations, etc.)
Drive document writing and review processes
Develop and maintains timelines for document generation, revision, and completion, with collaboration with other study team members
Coordinate and manage review cycles, incorporates team comments, and lead discussions on document revision and finalization
Must have excellent grammatical, editorial, and proofreading skills, and the ability to interpret and present extremely complex data
Assist in the development and maintenance of SOPs and writing tools, such as templates and style manuals
Provide training on medical writing templates, SOPs, and processes within the department and across departments
Contribute to the development of electronic document systems and tool
Provide quality control (QC) review of various regulatory and medical communications documents
Provide project team(s) with guidance and problem resolution related to document generation
Bachelor’s degree in a life sciences discipline and a minimum of 3-5 years biopharmaceutical industry experience, or a masters/PhD degree in a life sciences discipline and a minimum of 3 years biopharmaceutical industry experience
Minimum of 2 years Oncology Medical Writing experience
Experience preparing clinical regulatory documents and scientific publications are crucial
Prior NDA/BLA/MAA submission experience, including eCTD, is preferred
The candidate must have an in depth understanding of all regulatory guidance’s, standards and requirements pertaining to regulatory medical writing worldwide (eg ICH, FDA, EMEA)
The candidate must have experience in electronic document management and electronic regulatory submissions, tools and standards
The candidate must demonstrate strong communication skills, both written and verbal required to articulate concepts and ideas in cross functional team settings

192

Medical Writer Resume Examples & Samples

Minimum of 5 years direct CRO/pharma experience preferred, preferably in the assigned TA area
Medical writing experience in the TA area of expertise
Demonstrated computer skills – requires excellent MS Office experience (specifically Excel, Word, Outlook, Powerpoint)

193

Global Medical Writer Associate Resume Examples & Samples

Provide input and edit/review Clinical documents such as Study Protocols, Investigator’s Brochures and Informed Consent Forms
Review, improve and maintain existing documentation; prepare responses to Medical Information requests where appropriate
Systematic literature searches/reviews as necessary
Understand clinical and medical data for the product and competitors, provide the team with innovative stimulus about the product portfolio

194

Expert Medical Writer Resume Examples & Samples

Act as a member of clinical trial teams and submission teams and autonomously write/edit clinical study reports, CTD summary and overview documents, and other regulatory documents
Provide authoritative guidance to other line units and within DE with respect to regulatory submission documents and other document-related issues
As requested by DE management, act as lead writer on submissions and co-ordinate production of summary documents by medical writing team in collaboration with clinical team
Write/edit other strategic documents, as required, in collaboration with project teams and where necessary, with support from Senior Expert Medical Writers or DE leadership team members
Participate in planning of analysis and data presentation to be used in clinical programs, individual study reports or summary documents
Act as project medical writer for complex submission programs in clinical development
Contribute to development of document templates and processes both within DE and more widely

195

Senior Medical Writer Resume Examples & Samples

Serves as medical writing lead on clinical regulatory documents. Works closely with the Clinical and Regulatory team(s) on document strategies. Implements all activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (US and OUS)
Converts relevant data and information into a form that meets clinical regulatory document requirements and procedures. Explains data in manner consistent with clinical regulatory requirements
Effectively communicates clinical regulatory document deliverables needed, writing process, and timelines to team members. Holds team members accountable to agreed-upon project dates and with an appropriate quality level Manages processes for obtaining feedback for improvements for the documents. Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or elevation as appropriate
Understands/complies with appropriate conventions and style guides, proper grammar usage, and correct format requirements per journal/congress, ICH and other governing bodies following applicable divisional guidelines, templates, and SOPs
Knowledgeable of US and international regulations (e.g. MEDDEV Revision 4), requirements and guidance associated with clinical regulatory document preparation and submissions. Must continually train/be compliant with all current industry requirements as they relate to clinical regulatory submissions, including electronic submission/approval standards
Master’s degree
5+ year's industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/R&D
Experience with FDA and international regulations (device, e.g., 21 CFR 812, 11, 50, 54, 56, 803, 806, 820, ISO 13485, ISO 14155, MEDDEV, EU MDR)
Knowledge of ISO 14971, AIMDD, MDD, CMDCAS/ CMDR, JPAL and other international regulatory agency requirements
5+ years’ experience in investigational design and clinical/preclinical data interpretation preferred
Program/project management skills and demonstrated experience leading project teams
Knowledge and experience with Design History File, Technical File, Design Dossier, Clinical Study Report, Clinical Evaluation Report content templates. Working knowledge of current electronic document management systems and information technology
Ability to assimilate and interpret scientific content and translate information for appropriate audience
Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy
Expert in word processing, flow diagrams, and spreadsheets. Excellent working knowledge of software programs in Windows environment
Proficient computer skills and demonstrated competence to include word-processing, database applications, and spreadsheet in a network environment
Demonstration of self-motivation and leadership skills
Capable of performing work remotely
Able to manage complex tasks
Good understanding of statistical methods

196

Medical Writer Resume Examples & Samples

Serves as medical writing lead on assigned clinical regulatory documents. Works closely with the Clinical and Regulatory team(s) on document strategies. Implements all activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (US and OUS)
Coordinates the review, approval, and other appropriate functions involved in the production of clinical regulatory reports and deliverables. Arranges and conducts review meetings with the team. Ensures required documentation is obtained
Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to clinical regulatory documents
Serves as a department representative on project teams. Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments (e.g. eDocs, eCTD, journal/congress databases)
Bachelor of Science required,
3+ year's industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/ R&D
American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Medical Devices
3 years’ experience in investigational design and clinical/preclinical data interpretation preferred
Knowledgeable of US and international regulations, requirements and guidance associated with clinical regulatory document preparation, submissions, and reporting
Excellent written and oral communication skills. Experience in working with collaborative, cross-functional teams, including project management experience
Excellent written and oral communication skills and ability to interface professionally and diplomatically throughout all levels of the organization
Ability to work with international teams
Ability to manage time efficiently and prioritize tasks
Ability to prioritize tasks using a risk based approach
Strong interpersonal skills, ability to work with teams and be a self-initiator

197

Principal Medical Writer Resume Examples & Samples

4+ years of experience supporting industry-sponsored clinical research and/or 2+ years supporting medical/scientific publications
Experience in development and preparation of manuscripts in scientific formats
Strong knowledge of AdvaMed guidelines and Code of Ethics, CONSORT, ICJME, ISMPP code of ethics and the COPE Code of Conduct
Significant knowledge of clinical and outcomes research study design
Familiar with medical device and/or combination product trials and regulations
Strong knowledge-base in areas of cardiovascular and/or structural heart pathophysiology and therapy

198

Senior Medical Writer Resume Examples & Samples

Necessary bibliographic background research
Writing materials
Providing full reference sets
Incorporating all feedback provided by the client in a proper and timely manner
A minimum of 5 years of medical writing experience
Experience in mentoring Junior Medical Writers/ Medical Writers

199

Lead Medical Writer Resume Examples & Samples

Produce a full range of written communication in accordance with the needs of the customer and organization with considerations for the target audience, target publication (including adherence to formatting guidelines), publication medium, and level of design/creativity
Manage the publication effort through medical writing of meeting abstracts and presentations, corporate white papers and reports, and journal manuscripts. Lead team to ensure adherence to submission and company-driven deadlines
Contribute to and collaborate on statistical analyses and data quality checks for complete results interpretation and to ensure the delivery of accurate and relevant output, demonstrating advanced problem solving ability
Achieve editorial excellence, producing clear, accurate, grammatically correct, and creatively written work for a variety of audiences
Proactively communicate, as the primary liaison, with all relevant parties and manage projects to external and internal timelines and deadlines
Demonstrate a high level of product and procedure knowledge to support research-related questions and independently provide internal/external training as necessary
Provide training, mentorship, and guidance for junior team members in all aspects of data management, analysis, scientific writing, and utility of literature resources
Develop and implement corporate procedures for medical writing
Assist research and other project team members in additional responsibilities as required
Bachelor’s degree in Life Science, Biological Science, or related discipline
2+ years of experience as a medical writer in a healthcare-related field/industry
Strong understanding and comprehension of medical terminology
Proven experience of basic post-market project management, data management, data analysis, and advanced medical writing techniques
Required: Strong proficiency with Endnote (or equivalent), MS Office (Word, Excel, Access, PowerPoint), scientific search engines (PubMed, Google Scholar), image production software (Photoshop), and online journal/conference submission systems
Graduate degree
Experience in a clinical or industry setting with study experience focused on Spine, Orthopedics, or Medical Devices
Working knowledge of statistical analysis software (SAS, SPSS, JMP, R, or equivalent) and diagnostic image analysis software (PACS) preferred

200

Associate Principal Medical Writer Resume Examples & Samples

Independently prepares moderately complex clinical documents for one or more programs; coordinates preparation of clinical documents by other writers with minimal supervision
Represents department on clinical teams (e.g., study management teams, clinical development teams); leads document-related meetings; reviews statistical analysis plans and clinical data reports as needed
2+ yrs regulatory writing experience, consistently produces medical writing deliverables for clinical program(s)

201

Senior Medical Writer Resume Examples & Samples

Work closely with external authors and internal cross-functional areas to develop high-quality manuscripts and review articles for peer-reviewed journals as well as abstracts, posters, and slide presentations for scientific congresses and internal use
Assist in publication plans and strategic direction for scientific congress planning teams
Liaise as needed with medical directors, biostatisticians, safety experts, and health economists as well as external opinion leaders, investigators, authors and journal editors
May prepare/edit standard response letters and FAQ’s and acts as lead in the development and updating of these documents
Oversee the work of freelancers and vendors
Perform QC review of existing documents or parts of documents
Develops strong internal relationships with the R&D organization
Keeps abreast of current data, trends, medical knowledge, developments and advances in the Pain Therapy space
MS, PHD, PharmD or MD degree
Minimum 3 years relevant medical writing experience, focused on publications, for a biotech/pharmaceutical, medical communications agency or CRO
Experience in CNS and/or Pain Therapy areas a plus

202

Entry Level Medical Writer Resume Examples & Samples

Write clinical study reports, protocols, clinical development plans, FDA briefing documents, and IND, NDA, and MAA modules
Coordinate quality control reviews of documents and maintaining audit trails of changes; and
Provide input on data analysis planning and interpretation
Degree in a life science or engineering field (PhD preferred)
Prior experience in the research, pharmaceutical, or medical device industry preferred
Strong computer skills, project management skills, and a high attention to detail; and
Strong communication skills (both written and oral)

203

Medical Writer Resume Examples & Samples

Regulatory Writing
Clinical Submissions
Pharmaceutical Industry
Remote

204

Medical Device, Medical Writer Resume Examples & Samples

Acts as Lead Medical Writer on more advanced writing projects and performs competently, with guidance from senior staff
Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and
Good understanding of common statistical methods used in clinical trials and interpretation of their results
Ability to give a presentation to a project team and/or customer on project-specific topics, e.g. on lessons learned
Ability to identify deficiencies, errors, and inconsistencies in a protocol
Ability to identify deficiencies, errors, and inconsistencies in statistical output
Confidence in building relationship with customer and discussing Mediacl Writing issues with customers in person or on
Bachelor's degree in a life science-related discipline, plus 2.5 years' experience as a medical writer within a

205

Medical Writer Resume Examples & Samples

Write clinical documents including protocols, IBs, CSRs, patient narratives
Write regulatory documents including INDs, eCTD/NDAs (including ISS and ISE summaries), Advisory Committee presentations, and briefing books
Prepare scientific literature searches, abstracts, posters, and manuscripts
Analyze and interpret clinical study data
Ability and willingness to assist with Quality Control of documents produced within Adverum
Lead document review and comment resolution meetings with cross-functional teams
Ability to work closely with other writers and provide Quality Control of documents
Skilled at data analysis
Able to build and maintain effective partnerships
Strong organizational abilities
Motivated, self-directed, and able to work autonomously and in team settings to meet aggressive goals
Dedicated to producing high-quality documents
Ability to work in a collaborative and multi‐disciplinary environment

206

Senior Medical Writer Resume Examples & Samples

Direct, train, and assist other medical writers in the writing and editing of clinical and regulatory documents
Participate in cross-functional team strategy discussions, which may include nonclinical, clinical, and regulatory strategies
Experience working on NDAs, BLAs, and other submission activities
Experience mentoring/training other writers
Exceptional oral and written communication skills
Strong understanding of drug development, clinical study design, regulations and scientific principles
Able to manage time and expectations in a small group setting with limited/no administrative support
Excellent computer skills (Microsoft Office Suite) with advanced proficiency in MS Office (Word, Excel, and Outlook) required

207

Medical Writer Resume Examples & Samples

Quickly learn and become proficient with the BioPharm process for developing content
Understand medical-marketing strategies and content objectives for assigned accounts
Develop content that meets the stated objectives of the project, is within job specifications as defined by team/client, follows technical specifications, and is scientifically and medically accurate
Determine adequacy of references provided for projects and secure additional references or information as necessary
Accurately cite from references and appropriately underscore (or highlight) these references for medical/regulatory review
Address and incorporate edits requested by clients and KOL, as well as internal reviewers
Consistently deliver high-quality materials on time and on budget, working closely with cross-functional teams
Continually communicate project status to internal stakeholders through various formal and informal mechanisms
Attend kickoff, status, and other job-related meetings
Incorporate client changes and work with the team to address medical-legal review feedback
Strong medical writing skills (including appropriate annotations) for development of manuscripts in prose and power point slides with graphics
2+ years of experience as a medical communications medical writer
Solid understanding of bio-pharmaceutical industry including familiarity with the promotional review process
Ability to quickly learn new medical/marketing subject matter and correctly interpret medical data
Bachelor’s degree is mandatory, Master’s degree in science or higher required. PhD/PharmD preferred
High level of attention to detail to ensure accuracy with medical content, including referencing
Successful track-record of meeting deadlines while managing multiple projects simultaneously
Excellent oral communication skills with clients, KOLs, and BioPharm team members, as well as strong listening and analytical skills

208

Medical Writer Resume Examples & Samples

Write intelligent, creative and engaging copy – whether subject lines, website copy or email layouts
Portfolio containing work samples that demonstrate creative thinking and exceptional writing skills
Able to multitask in a fast paced environment while functioning as a member of a highly collaborative team

Download Medical Writer Resume Sample as Image file

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