Medical Writing Job Description
Medical writing
provides medical support for the regulatory department, and acts as compliance monitor for trials, ensuring compliance with global and local SOPs and ICH GCP guidelines.
Medical Writing Duties & Responsibilities
To write an effective medical writing job description, begin by listing detailed duties, responsibilities and expectations. We have included medical writing job description templates that you can modify and use.
Sample responsibilities for this position include:
Prepare documents that adhere to regulatory guidelines, or journal/authorship requirements and ethical publishing standards, including internal guidelines and electronic standards and guidelines
The Head of Medical Writing provides senior leadership and coordination of all medical writing activities across multiple projects across all programs
Responsible for strategic planning of medical writing deliverables and provides strategic direction to clinical and cross-functional project teams relative to consistency of key messages across documents in concordance with program goals and regulatory requirements/guidance
Ensures timely preparation of all clinical regulatory documents (e.g., investigators’ brochures, study reports, integrated summaries, clinical overviews, contributions to briefing documents, response documents, and other IND/CTA or global regulatory submission documents) to ensure high quality with regard to scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes
Manages and coordinates work of other writers, editors, and document specialists (internal or contractors) as required for timely high quality clinical regulatory submissions
Ensure scientific integrity and consistency of information within and across documents in a given program and will prepare or oversee the preparation and finalization of basic and complex clinical document
Be able to take a strategic role in positioning content in submission-level documents
Manage a staff of medical writers in the preparation of clinical documents
Train and coach writers to take a proactive or lead role for document content and scientific collaboration, in functional area expertise
Oversee the preparation and finalization of basic and complex clinical documents with a high level of independence
Medical Writing Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Medical Writing
List any licenses or certifications required by the position: AMWA, BELS
Education for Medical Writing
Typically a job would require a certain level of education.
Employers hiring for the medical writing job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Medical, Life Sciences, Writing, Science, Life Science, Graduate, Health, Communications, English, Education
Skills for Medical Writing
Desired skills for medical writing include:
Clinical trial experience
Global Medical Device Regulatory Requirements
Global regulatory requirements and ICH/GCP guidelines
End-to-end drug development process
FDA
ICH and CTD guidelines for clinical and regulatory submission documents
Writing guidelines
AMA
MS Word
Regulatory guidelines
Desired experience for medical writing includes:
Take a highly proactive or lead role in terms of content, engages in scientific collaboration, and trains/coaches others to do the same
Work collaboratively in a team environment, and takes a proactive role on multiple assigned projects with respect to timing, scheduling, tracking, and publication strategy as appropriate
The Manager may also be responsible for a group of medical writers, including mentoring and coaching, training new employees, and performance management and career development
Prepare and finalize basic and complex scientific/clinical documents as assigned with minimal supervision
Make decisions that impact data interpretation and presentation in documents that will be viewed by external authorities
Decide on strategies for the best project management approach within process/timeline constraints and appropriate deviations from normal practice to meet unique challenges
Medical Writing Examples
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Medical Writing Job Description
Job Description Example
Our innovative and growing company is looking for a medical writing. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for medical writing
- May provide guidance to contractors and oversee the work of other medical writers, external contractors, and document specialists supporting a project
- May manage the work of document/project team members without authority over them
- Work collaboratively in a team environment with minimal direction and take a proactive role on multiple assigned projects with respect to timing, scheduling, and tracking, as appropriate
- Contribute scientifically and strategically and may lead submission-level, strategic activities for writing team
- Proactively identify opportunities for greater productivity and participate in finding flexible solutions
- Demonstrate excellent listening skills and be proficient at sending clear, convincing, and well-tuned messages through a variety of media including but not limited to business discussions (one-on-one or larger groups) and e-mail messages
- Negotiate with and influence others with regard to scientific content and processes
- Overall accountability for providing leadership and direction, implementing the development and maintenance of standardized training materials/tools, and, the development of the Word Processing personnel
- Overall accountability for scheduling work and managing workload for the Word Processing personnel
- Supports/acts as back up to Senior Manager, Medical Writing Word Processing & Standards, who executes the creation and maintenance of global clinical standards related to the submissions process
Qualifications for medical writing
- Identifies and implements new procedures needed as the Medical Writing organization evolves with an overall emphasis on a quality system that supports the clinical regulatory writing process and the production of submission-ready documents
- Supports/acts as back up to Senior Manager, Medical Writing Word Processing & Standards, who owns overall accountability for document template creation, maintenance, and, management
- Applies practical experience and knowledge in process improvement and change leadership related to clinical regulatory documents
- At least 10 years of Medical Writing experience
- Demonstrated people development and management skills
- Extensive experience writing all types of clinical & regulatory documents for worldwide use
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Medical Writing Job Description
Job Description Example
Our company is looking to fill the role of medical writing. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for medical writing
- Participates in cross-functional submission teams, other teams, and provides guidance on regulatory submission document strategies
- Attends and participates in routine departmental meetings
- Leads or participates in process improvement initiatives
- Prepare sound scientific/regulatory documents with supervision using established templates and guidelines
- Interpret and coordinate statistical and medical interpretation of data into the appropriate organization and document structure to ensure quality and accuracy of content
- Prepare and finalize basic and complex clinical documents with supervision
- Prepare documents of high quality in terms of scientific content, with attention to format, consistency, and accuracy
- Prepare documents within established timelines and in accordance with internal processes
- Engage in scientific collaboration with clinical and other functional areas to ensure integrity of documentation
- Provide a significant contribution for projects of low-medium complexity and take an increasingly active or lead role on assigned projects with respect to planning of content, format, scheduling, and tracking as appropriate
Qualifications for medical writing
- Advanced degree in Life Sciences (e.g., biology, chemistry, pharmaceuticals) or medical degree
- Knowledgeable in preclinical development
- Experience in leading teams to produce clinical regulatory submission documents, including CTD Module 2 summaries
- Demonstrated experience mentoring and managing the project work of other Medical Writers
- Experience in the Therapeutic area(s) assigned
- Strong understanding of drug development, study design, and biostatistics
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Medical Writing Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of medical writing. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for medical writing
- Interpretation of study results and generation of study reports for assigned product responsibilities
- Coordinates with Biostatistics to obtain necessary data tables and listings for clinical study reports
- Responsible for clinical evaluation reports for assigned product responsibilities by conducting literature searches, evaluating and assessing scientific literature and available clinical evidence (clinical study outcomes, post-market surveillance data, ), providing clinical input to post-market surveillance reports (post-market clinical reports, , PMCRs)
- Participating in cross-functional post-market surveillance meetings for risk assessment updates, and maintaining CERs and CER updates in a document control management system
- Provide input into case report form design (e.g., EDC) and data collection methods for reporting purposes
- Stay current with product regulatory guidance documents
- Maintain compliance with corporate policies, state, federal and international regulations
- Maintain templates for clinical documents including test methodology instructions
- May assist in selecting providers, managing vendor contracts, and ensuring expenditures are within budgetary guidelines
- Enforce the Abbott Quality System standards
Qualifications for medical writing
- Expert knowledge of international regulations, requirements, and guidelines associated with clinical regulatory document preparation and submissions
- Effective influence and relationship management skills
- Must be highly motivated, able to work independently, and willing to accept and assume a leadership role
- Must be able to communicate effectively in large, small, and virtual group settings
- Strong project management skills, detail oriented, and ability to organize and prioritize simultaneous projects
- Able to work well with all levels of multicultural staff
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Medical Writing Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of medical writing. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for medical writing
- As Head Global Medical Writing you will ensure provision of high-quality, compliant deliverables (e.g., clinical study reports, submission documents ) to regulatory authorities worldwide to support product development objectives and the growth of the portfolio
- As responsible for Scientific Writing deliverables of assigned projects, oversees, coordinates and/or writes documents to support operational and strategic goals of such as study reports, concept protocols and study protocols clinical summary modules, global epidemiology plans and briefing documents
- Build capability by refining and expanding activities to optimize benefits of co-location or remote working
- Circulate drafts to the SMEs and stakeholders for review
- Review procedures for formatting and grammer errors for clarity and accuracy
- Providing mgmt
- Develop QDs (SOPs, Working Instructions and Supporting Documents
- Peer QC of content of QDs
- Acts as a primary GMWRL generally for several early-stage development projects and/or acts as a back-up/supporting GMWRL for several early-stage development projects
- As a document specialist, provides intellectual leadership and contributes document knowledge and expertise to the global project team
Qualifications for medical writing
- 6+ years relevant industry experience in medical writing or a related area such as quality, regulatory, clinical research, or product support/R&D
- Knowledge of a wide variety of statistical and programming techniques, SAS
- Native English speaker or have proven fluency in English (oral and written) – knowledge of an additional language might be beneficial
- A PhD or equivalent advanced degree with a minimum of 3 years of relevant pharmaceutical/scientific experience is required OR a Master's or equivalent advanced degree with a minimum of 4 years of relevant pharmaceutical/scientific experience is required OR a Bachelor's degree with a minimum of 5 years of relevant pharmaceutical/scientific experience is required
- Experience in the pharmaceutical industry or related industry experience is required
- Research experience (including compilation of research reports or publications) in academia or the pharmaceutical industry or as part of a PHD, Pharm.D, or postdoctoral program is preferred
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Medical Writing Job Description
Job Description Example
Our growing company is looking for a medical writing. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for medical writing
- In addition to GMWRL responsibilities, may act as a Document Working Group Facilitator (DWGF
- An advanced degree in Life Sciences, Business or related field
- Experience with Clinical Study Protocols and Reports
- Understanding of Document Management Systems and advanced technical skills
- Experience in Business Process design and documentation and ability to develop and deliver training
- Draft new cross-functional SOPs (owned by RWE Scientific Affairs MW)
- Act as Project Leader for a large stand-alone program, including more than one document type and/or region
- May act as Lead Medical Writer on any type of writing project to an exemplary standard and can advise others on any type of document
- May review and monitors budget for assigned projects, including out of scope activities, and ensures that revenue is recognised as appropriate
- May plan and deliver workshops or presentations on Medical Writing topics, for a conference
Qualifications for medical writing
- Bachelor of Science required, with relevant writing experience, or Bachelor's degree in English or communications, with relevant science experience
- Experience in writing clinical regulatory submission documents, such as Clinical Study Reports, Investigator’s Brochures, Clinical Study Protocols, CTD Summary Documents (i.e., Efficacy and Safety Summaries, Clinical Overviews, ), Responses to Regulatory Questions, Briefing Documents, and safety documents
- Able to adapt to working in a multicultural environment
- Responsible for build and test, root cause analysis, and complex performance tuning
- Will be expected to write documentation to describe program development, logic, coding, and corrections
- Write manuals for users to describe installation and operating procedure