Associate Director, Medical Resume Samples

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AB
A Borer
Adonis
Borer
23703 Zelda Valley
Boston
MA
+1 (555) 850 8066
23703 Zelda Valley
Boston
MA
Phone
p +1 (555) 850 8066
Experience Experience
11/2014 present
Dallas, TX
Associate Director Medical & Clinical Operations
Dallas, TX
Associate Director Medical & Clinical Operations
11/2014 present
Dallas, TX
Associate Director Medical & Clinical Operations
11/2014 present
  • Collaborates across OCHS and UHG including Medical, Site Directors, senior leaders, sales, account management, product organization, and other stakeholders
  • Remain current with trends and research developments in the industry related to your area
  • Product, service or process decisions are most likely to impact entire functions and / or customer accounts (internal or external)
  • Owns an end to end process driving high quality execution
  • Identify operational efficiencies to enhance operations, reduce operating costs, and standardize best practices across the organization
  • Drives staff function programs at the business level
  • Identifies and resolves technical, operational, and organizational problems outside own team
11/2008 09/2014
Houston, TX
Associate Director, Medical Information
Houston, TX
Associate Director, Medical Information
11/2008 09/2014
Houston, TX
Associate Director, Medical Information
11/2008 09/2014
  • Developing and providing timely responses to unsolicited medical information requests according to Lexicon and regulatory guidelines
  • Reviewing and approving Standard Response Letters (SRLs) for assigned products in conjunction with medical information or medical writing vendors
  • Representing Medical Affairs in the review of promotional materials during Promotional Materials Review Committee and Medical and Medical Scientific Review Committee meetings
  • Overseeing and managing the internal review for CME grant requests and IIS proposals in multifunctional process
  • Utilize expertise and functional knowledge of the literature to collaboratively and effectively work within cross-functional teams to provide scientific input into the development strategy of Kite Pharma investigational therapies
  • Lead and participate in the development and ongoing maintenance of Medical Information policies and procedures
  • Management of Kite Pharma’s centralized medical information database including document access, tracking, storage and retrieval
04/2003 05/2008
San Francisco, CA
Associate Director, Medical Writing
San Francisco, CA
Associate Director, Medical Writing
04/2003 05/2008
San Francisco, CA
Associate Director, Medical Writing
04/2003 05/2008
  • Develops and manages timelines for the delivery of clinical and regulatory documents
  • Develops strong internal relationships within the R&D organization
  • Liaises with other functional areas and groups in the development of document standards and structure
  • Develops effective collaborations with other functional lines in Alexion, and externally with regulatory, industry, professional, and academic organizations
  • Supports the document management system
  • Advanced working knowledge of MS project and MS Word
  • Provides oversight to medical writing resources at vendors and CROs
Education Education
Bachelor’s Degree in Life Sciences
Bachelor’s Degree in Life Sciences
Harvard University
Bachelor’s Degree in Life Sciences
Skills Skills
  • Strong attention to detail
  • Highly self-motivated and able to handle multiple-tasks in a timely
  • Excellent project management skills
  • Scientific knowledge expertise
  • Strong business acumen
  • Proficiency with PC based applications, including Microsoft Word, Excel and PowerPoint
  • Organizational and planning skills, be detail-oriented
  • Support ongoing training for Call Center personnel, review/update standard response letters, FAQ documents, and maintain quality control procedures
  • Excellent project management and time management skills
  • Excellent oral and written communication skills
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1

Associate Director, Medical Operations Resume Examples & Samples

  • Design, implementation and management of Programs for contract management and other key programs as required. Act as change agent, support the development and implementation of improved standards
  • Independently negotiates and finalizes agreements including master contracts, clinical trial agreements, general services agreements, CDAs and other agreements
  • Develop processes to ensure oversight and compliance with Novartis guidelines through the development of stakeholder training programs, working practices (WPs) and effective communication
  • Full knowledge and understanding of clinical research phase 1-IV
  • Expert clinical knowledge of outsourced trials
  • Create and manage metrics and analytics at the department and program level. Work with supervisor to develop root cause analysis and action plans to implement process improvements and risk mitigation strategies
  • Manage relationships with cross-functional business partners and other NPC stakeholders
  • Ensure compliance with Novartis systems & SOP’s and Sunshine, CIA and Anti-bribery
  • Support medical teams in the execution and problem solving of contract and process related issues
  • Support US Oncology productivity and efficiency culture through identification of opportunities improve processes and reduce cost on a sustainable basis
  • Conduct above activities with high level oversight and mid/high-level competency
  • Display strong organizational/project management/interpersonal skills, communication skills
  • Be a performance-oriented individual
  • BS/BA or advanced degree is required a legal degree preferred
  • Candidates must have 7-10 years of contract management with progressive experience in Clinical Trial Management/Operations and/or experience with external transition/joint programs/trials
  • Prior experience with clinical trial/medical contracts preferred as well as process improvements experience
2

Associate Director, Medical Writing Resume Examples & Samples

  • Develop and implement clinical document strategy for clinical documents, including clinical study protocols, clinical study reports, Investigator’s Brochures and updates, smaller scope regulatory submission documents (includes Module 2 summaries), risk management plans, contributions to briefing documents, response documents, pediatric investigational plans, and other IND/CTA or global regulatory submission documents, working cross-functionally and with minimal supervision
  • Manages the writing and completion of documents and other assigned tasks within established timelines (editing and QC) and with highest quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes
  • Actively supports clinical project team(s), representing Medical Writing and takes responsibility for timely and accurate MW deliverables, negotiating timelines as necessary
  • Participates with other medical writing team members to formulate writing strategies and standards to be implemented and takes responsibility for execution
  • Develops effective collaborations with other functional lines in Alexion, and externally with regulatory, industry, professional, and academic organizations
  • Ensures consistent support and implementation of medical writing standards
  • Reviews, edits, and ensures quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensures adherence to standards
  • Ensures that all activities are conducted in compliance with relevant regulatory requirements
  • Partners with Scientific Communications to support clinical trial results, publication activities, and scientific presentation and promotional material for assigned projects
  • Maintains adherence to uniform processes and stands in partnership with statistical, clinical, regulatory and pharmacovigilance colleagues
  • At least 5 years medical writing experience or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge
  • Experience with global trials and regulatory submissions preferred
  • Experience with partnering and managing CRO relationships a plus
  • Proven excellence in operational strategy; experience with developing, implementing, and measuring the impact of medical writing processes and systems across multiple projects
  • Experience desired in medical writing for ultra-rare diseases and capability to develop and implement innovative solutions for optimizing medical writing for ultra-rare disease studies
3

Associate Director, Medical Resume Examples & Samples

  • To establish the presence and reputation of Celgene through thought leadership, liaise with key opinion leaders in the fundamental issues affecting the industry and contribute to the advancement of Celgene
  • Identifies the need for medical/scientific training of the Nordic internal staff and designs, coordinates and conducts the training of the Nordic internal staff on disease and product specific topics
  • Is highly involved in the development and management of IIT’s
  • Supports the Medical Director on request in coordinating and conducting feasibility studies (early stage development)
  • May represent the medical department in the brand team for the different Celgene products and provides constructive input in the development of the brand strategies and the proposed promotional items from a medical perspective
  • Supports the marketing and sales team in answering questions from health care professionals e.g. on non registered indications and products
  • Performs other duties as assigned by the Medical Director
  • Supports the implementation RMP programs for Celgene compounds; gives scientific presentations at hospital sites/cooperative groups/ hospital formularies
  • Is a medical doctor by training (preferably PhD.)
  • Minimum 5 years experience in the pharmaceutical industry in a relevant area e.g. medical affairs, clinical operations
  • Strong leadership and management skills
  • Strong communication (both verbal and written, both in local language and English) and organizational skills
  • Knowledgeable in the area of hematology/oncology
  • Excellent written and verbal communication skills (English) and interpersonal skills. Must be able to relate effectively with professionals working in the oncology area
  • Good knowledge of all the applicable (regulatory, promotional etc) rules and regulations
  • Valid drivers license
4

Associate Director, Medical Review Resume Examples & Samples

  • MD or international equivalent
  • Specialist accreditation desirable Experience
  • Six (6) years relevant experience, including training
  • Two (2) years drug safety experience
  • Clinical experience preferred Knowledge
  • Medical aspects of drug safety
  • Pre- and post-marketing safety practice
  • Regulatory requirements across drug safety
  • Clinical development process and operations
5

Associate Director, Medical Clinical Ops Resume Examples & Samples

  • Assist in the formulation of the overall strategic plan and ensure adequate communication and execution within the OptumCare Network
  • Develop Practice Managers as leaders and ensure that they have the tools and skill sets to execute their operating plans
  • Develop and promote strong communication among physicians and operational staff
  • Guide the development of the strategic marketing and public relations plans for owned practice growth initiatives
  • Bachelor’s degree in public health or related field; and/or equivalent and relevant work experience
  • 2+ years of experience in medical practice management, health plan operations or Medical Management in management positions with successive promotions
  • Thorough knowledge of leadership roles of practice management for physician groups, strong understanding of reimbursement and delivery systems for healthcare
  • Strong leadership and organizational skills including group and team building, coaching, communication, change management, and people/product focus balance
  • Advanced ability to develop people, empowerment and accountability at all levels
  • Strong sense of integrity and ability to command the respect of patients and employees at all levels
  • Ability to create and maintain a caring culture; must possess strong analytical skills
  • Demonstrate ability to lead groups successfully coupled with strong interpersonal, excellent oral and written communication skills
  • Master’s degree in Health Care Management or related field preferred
6

Associate Director Medical & Clinical Operations Resume Examples & Samples

  • Provides leadership to and is accountable for the performance of managers and / or senior level professional staff
  • Owns an end to end process driving high quality execution
  • Develops, functional, market level, and/or site strategy, plans, production and / or organizational priorities including medical management, financial accountability, customer and provider satisfaction, quality improvement
  • Identify operational efficiencies to enhance operations, reduce operating costs, and standardize best practices across the organization
  • Systematically analyze problems, draw relevant conclusions and devise appropriate courses of action
  • Collaborates across OCHS and UHG including Medical, Site Directors, senior leaders, sales, account management, product organization, and other stakeholders
  • Identifies and resolves technical, operational, and organizational problems outside own team
  • Drives staff function programs at the business level
  • Influence and negotiate through active listening and presenting logical and persuasive case when offering ideas and options
  • Remain current with trends and research developments in the industry related to your area
  • Leads change and innovation
  • Registered Nurse with current licensure
  • Complex Case Management certification required or willing to obtain within 2 years
  • 3+ years of management experience and leading staff
  • 5+ years of experience in health care industry including clinical experience, insurance, health promotion, and operations (specific department requirements may vary)
  • Ability to initiate and drive change, influence individuals at all levels of the organization, and to take appropriate risks
  • Computer and technical aptitude
  • Strong written, communication, and presentation skills
  • Baseline financial acumen and the ability to use data in directing and prioritizing work
  • Located in Greensboro, NC is strongly
  • Experience working with Medicare & Retirement membership
  • Experience working on ICUE (our clinical operating system)
7

Associate Director, Medical Information Resume Examples & Samples

  • Advanced degree in Pharmacy (PharmD preferred), Pharmacology, science or equivalent clinical experience
  • 3-5 years of experience in pharmaceutical industry based drug information delivery or equivalent industry experience with at least 1-2 years of experience working with Commercial or Brand Teams
  • Demonstrated expertise in drug information communication and management
  • Demonstrated expertise in the review of promotional materials
  • Excellent oral and written communication skills and interpersonal skills
  • Ability to apply FDA, legal, regulatory, and compliance requirements to Medical Affairs activities and drug information delivery
  • Demonstration of strategic thinking
  • Understanding of the information needs for various customer segments
  • Experience leading projects and teams
  • Clinical pharmacy experience with patient care exposure
  • Pharmacy licensure preferred
  • Training related experience
  • MM or HEOR experience
  • Scientific knowledge expertise
8

Associate Director Medical Resume Examples & Samples

  • Execute and operationalize the strategic medical plan for interacting with the patient advocacy groups at the National/ Regional and Local levels
  • Provide disease area and product expertise across the Biogen portfolio working in collaboration with the medical director’s team to the National/ Regional and local patient advocacy groups. Activities ranging from educating the society’s scientific department members, making sure that their questions are addressed, and providing informational services to patient advocacy groups, as requested
  • Collaborate with Government Affairs to execute strategic medical plan to impact health care policy at the State and Federal level
  • Partner with Payers and Centers of Excellence across all therapeutic areas to explore ways to advance patient centered specialist care, to educate patients/payers/providers on the importance of patient reported outcomes and quality initiatives, to identify innovative opportunities/engagement for patient enrollment in ongoing BIIB clinical (registrational and phase IV real world data generation) studies
  • Innovate with Payers and Providers to bring innovative solutions and approaches that include health technology advances, clinically applicable tools and social media
  • Execute and operationalize Quality Initiatives in MS and Hemophilia
  • Excellent interpersonal skills/ highly collaborative/ strong executive presence
  • Ability to drive consensus across diverse stakeholders to achieve goals
  • Embraces the Culture of Excellence and core behaviors at Biogen Idec
  • Ability to cultivate strong internal/external network
  • Strong operational skills; project/ timeline management capabilities
  • Excellent problem-solving skills and judgment
  • Anticipates and proactively addresses issues before they reach crisis point
  • Ability to learn on the fly/ quickly identifies what’s important and what’s not
  • Organizational agility
  • Sensitivity and orientation to identify systemic issues
9

Associate Director Medical Contact Center Ops Resume Examples & Samples

  • Responsible for ensuring accuracy and completeness of Americas’ Hub unsolicited Medical Responses as well as ensuring all Adverse Events and Product Quality Complaints are identified and reported per Country regulations
  • Responsible for ensuring Relationship and Performance Management of all Hub Medical Contact Partners
  • Accountable for coordinating and aligning Medical Contact processes across the MCCI matrix, supporting the Market Medical Leads in driving alignment and service delivery excellence
  • Project management responsibility, leading a matrix team in the deployment of Enterprise and Medical objectives and initiatives
  • BIA Medical Contact Contributor
  • IT Business Requirements Contributor
  • Business Continuity Planning Management of Medical Contact Partners/Annual Stress Test lead
  • Engagement Quality/Customer Experience/Training Delivery/Audit Lead
  • Statement of Work/Budget/Project Scope Lead
  • Support Hub Lead by providing guidance and Medical Contact Partner representation on new Contact Channel capabilities and implementation, ie: Digital, Chat, IVR, CTI
  • College degree required, Scientific/Pharmacy degree is preferred
  • Prior experience managing internal Medical Information Contact Channel or Outsourced Medical Information Partners preferred
  • Prior experience managing and leading teams in a global, highly matrixed organization
  • Demonstrated ability to work across countries/markets
  • Previous experience managing a large system/process development and implementation
  • Experience leading and managing dynamic change in organizations
  • Decision making and stakeholder management
  • Ability to build relationships with Key stakeholders (interpersonal skills) and influence stakeholders
  • Exposure to/Experience leading Project Management or Lean Six Sigma approach
  • Work in a rapidly changing, fluid environment with “continuous improvement mindset”
  • 1604371
10

Associate Director Medical Review Resume Examples & Samples

  • Manages and develops staff of health care professionals responsible for the interpretation and communication of complex medical, pharmacological and scientific information. Ensures all medical content presented externally by AbbVie meets the highest standards of medical accuracy and is compliant with local and global standards as appropriate. Maintains knowledge of all applicable regulations and guidance documents and accurately interprets and applies them
  • Works with Therapeutic Area (TA) head to ensure Medical Review team strategies and tactics align with both the TA and Commercial strategies
  • Collaborates with senior management on strategic planning for Medical Review and implements organizational changes
  • Defines the boundaries of accepted risk tolerance, recognizes and manages business risk and potential liability to the team. Develops medical defense and alternative solutions to medical presentations to mitigate business risks
  • Represents Medical Review in cross-functional high-level decision-making
  • Guides staff decision making to incorporate broader scope implications to minimize risk
  • Advises teams on best practices regarding planning and execution of both marketing and medical strategies. Assures that cross-functional advertising and promotion review teams are operating according to approved company processes
  • Manages team workflow and deliverables to meet TA and/or cross functional initiatives
  • Maintains level appropriate understanding of product knowledge, associated disease states and treatment guidelines, labeling, and relevant data. Knowledge may span multiple therapeutic areas across all lifecycle phases, including pipeline and/or launch
11

Associate Director Medical Devices Combination Product Capa Resume Examples & Samples

  • Supports maintenance, knowledge transfer, and as needed development of Merck’s Device specific Quality Management System
  • Participates on Merck teams supporting (MDCP) Current Good Manufacturing Practice (CGMP) and quality issues related to pure medical devices and the device constituent of a combination product
  • Provides guidance in the preparation of metrics, procedures and guidelines
  • Provides proactive support in training and coaching to initiate quality improvements within Development, Operations and Quality
  • Audits and approves Design Control and Device Risk Management GMP documentation for applicable regulatory filings, clinical supply, development and design transfer qualification. Ensure compliance with regulatory and Merck requirements. Evaluate deficiencies and assess impact on compliance status
  • Contributes to developing/revising policy and procedures for MDCP Quality and /or supported areas
  • Expert knowledge of medical device regulations and compliance in a specialized area with experience in their application, including current GMPs for combination products
  • Effective interpersonal skills and ability to work collaboratively across diverse teams and networks; able to foster cooperation in others
  • Able to apply prior experiences and learnings in new settings, even if these are unfamiliar
  • Working knowledge of technical aspects of device development and commercialization
  • Development, product approval, and/or inspection experience with the medical device constituent of a combination product is an asset
12

Associate Director, Medical Writing Resume Examples & Samples

  • Manages planning and preparation of clinical and regulatory documents which include but are not limited to clinical study protocols, clinical study reports, investigator brochures, briefing books, integrated summaries, IND sections and other regulatory submission documents
  • Coordinates the cross-functional review of clinical and regulatory documents
  • Develops and manages timelines for the delivery of clinical and regulatory documents
  • Provides high-quality deliverables in compliance with regulatory requirements and internal SOPs
  • Responsible for consistent style guide, templates and formats of clinical and regulatory documents
  • Provides oversight to medical writing resources at vendors and CROs
  • Responsible for medical writing project budgets
  • Represents medical writing on cross-functional teams
  • Supports the document management system
  • Develops strong internal relationships within the R&D organization
  • Keeps abreast of regulations and developments in medical writing and maintains relevant knowledge of the therapeutic area
  • MS, PhD, PharmD or MD degree
  • Minimum of 7 years relevant clinical development medical writing experience in pharmaceutical, biotech or CRO positions
  • Knowledge of ICH, GCP and relevant regulatory guidelines
  • Experience in CNS and/or pain therapy preferred
  • Excellent writing, communication, project management, interpersonal skills
  • Excellent ability to interpret and present scientific, clinical and statistical data
  • Demonstrated ability to work on several projects at once while balancing multiple and overlapping timelines
  • Demonstrated abilities in both collaboration with others and independent work
  • Computer proficiency in Microsoft Office, Microsoft Visio and Adobe Acrobat required
13

Associate Director, Medical Writing Resume Examples & Samples

  • Working with the clinical team, the Associate Director, Medical Writing will be responsible for writing Clinical Study Protocols, Clinical Study Protocol Amendments, Clinical Study Reports, Patient Safety Narratives, Clinical Summaries, and other documents, as needed
  • Represent medical Writing at cross-company and TA meetings
  • Minimum of 10+ years of industry experience to include a minimum of 8+ years of Medical Writing experience
  • Have strong organizational, interpersonal and communication skills, and be able to develop and present varied and unique ideas
  • Have a good working knowledge of PDF, and Project. Skilled in use of MS WORD. Have used 1 or more EDM systems
14

Associate Director, Medical Information Resume Examples & Samples

  • Developing and providing timely responses to unsolicited medical information requests according to Lexicon and regulatory guidelines
  • Reviewing and approving Standard Response Letters (SRLs) for assigned products in conjunction with medical information or medical writing vendors
  • Optimizing and supporting the medical information operational processes at Lexicon by ensuring medical information vendor/call center is appropriately trained on product and process
  • Representing Medical Affairs in the review of promotional materials during Promotional Materials Review Committee and Medical and Medical Scientific Review Committee meetings
  • Overseeing and managing the internal review for CME grant requests and IIS proposals in multifunctional process
  • Pharm.D. preferred, other relevant scientific degrees considered
  • At least 5 to 10 years’ of relevant industry experience with at least 3 years in a medical information role
  • Experience in related functional areas such as pharmacovigilance, medical writing, medical affairs, regulatory affairs or clinical development is highly desirable
  • Must be highly motivated with demonstrated track record of high performance and excellence
  • Must have experience with applying legal and regulatory guidelines in drug development, including knowledge of OPDP promotional regulations, and CDER/CBER
  • Experience working in a matrix, multifunctional team environment
  • Strong strategic, problem-solving, risk mitigation, interpersonal, and communication skills
  • Excellent project management and operational skills
  • Ability to address issues/concerns in a clear, well-informed manner that engages others in a thoughtful discourse; able to stand up in a polite way and make the case
  • Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
  • Possesses a collaborative, results-driven style
  • Must be willing and able to travel 10-20%
15

Associate Director, Medical Information Resume Examples & Samples

  • Management of Kite Pharma’s centralized medical information database including document access, tracking, storage and retrieval
  • Authorship of standard response letters and FAQ documents to be used by Call Center personnel and field-based medical professionals in response to unsolicited medical inquiries
  • Directly and independently handle unsolicited medical inquiries escalated to the level of Senior Manager/ Associate Director
  • Utilize expertise and functional knowledge of the literature to collaboratively and effectively work within cross-functional teams to provide scientific input into the development strategy of Kite Pharma investigative therapies
  • Ongoing literature surveillance of hematology/oncology landscape to ensure timely internal communication of key scientific findings
  • Support ongoing training for Call Center personnel, review/update standard response letters, FAQ documents, and maintain quality control procedures
  • Represent Kite Pharma at major scientific meetings and conferences
16

Associate Director, Medical Information Resume Examples & Samples

  • Oversee Medical Information Service including vendor management, review of monthly reports of Medical Information Request Form reports, resource allocation and budget management
  • Provide clinical, product and process training to external contact center staff, and monitor the quality of outputs/service
  • Develop and update standard response documents, including standard response letters and “frequently asked questions” (FAQ) documents by utilizing the highest level of scientific data so that healthcare providers are able to make informed clinical decisions about the company's products
  • Respond with a sense of urgency to unsolicited medical information questions, from healthcare providers (HCPs) and payer and managed healthcare organizations, which are not covered by existing responses
  • Support development of and updates to medical information payer content and related documents by collaborating and building a strong relationship with internal partners (Medical Affairs, Health Outcomes, Market Access and Legal) so that payer and managed care organizations have the necessary resources they need to make decisions regarding products
  • Review new and relevant data so that medical information content is updated proactively resulting in the most current information in medical information resources for Medical Affairs colleagues and contact center staff to share with HCPs regarding products
  • Collaborate with Medical Science Liaison team to create topic specific presentations to share new information regarding a product/disease state or help fulfill knowledge gaps
  • Collaborate with internal partners to support the Medical, Legal, Regulatory Review and Medical Review committees, to ensure the provision of medical information is accurate and scientifically balanced
  • Work with members of multidisciplinary project teams to contribute to review of results of current and future studies and development of abstracts/presentations of results
  • Willingness to travel occasionally, up to 10% of role
  • PharmD degree required
  • A minimum of 3 years’ professional experience in Medical Affairs/Medical Information
  • Medical/Drug Information or postdoctoral training/fellowship in specialty area
  • Residency and/or postdoctoral training in a clinical practice/pharmaceutical industry setting
  • Demonstrated evidence of cross-functional integration with ability to progress projects and influence colleagues in a team setting
  • Demonstrated strong verbal, written, and presentation skills. Ability to communicate clearly to individuals and groups with diverse academic backgrounds
  • Experience working in a pharmaceutical industry environment
17

Associate Director, Medical Writing Resume Examples & Samples

  • Working on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
  • Independently prepares and at times may direct, the writing of PCSs, protocols and protocol amendments
  • Independently prepares and at times may direct, all the writing of the CSRs including narratives
  • Works across functional areas to obtain all applicable source materials
  • Leads the preparation of clinical sections of submission documents, such as the briefing books, Global Investigator Brochures, and annual regulatory reports
  • Leads the medical writing activities for marketing application submission documents
  • Liaises with other functional areas and groups in the development of document standards and structure
  • Interacts routinely with clinical research and biostatistics staff to gain comprehensive understanding of the study design, and results across the program
  • Implements document quality controls, standards and best practices
  • BS required/MS preferred
  • Minimum of 8 years medical writing experience in an industry setting, with specific experience with compounds in Neuroscience
  • Must have participated in or lead a major marketing application submission
  • Strong critical thinking and problem solving skills
  • Ability to multitask on complex projects
  • Result driven with a mastery of time management and project planning
  • Experienced in the use of a documentum system
18

Associate Director, Medical Devices Resume Examples & Samples

  • Executing with development, safety and clinical groups Device Risk Management Files from initiations to obsolescence
  • Expert knowledge of ISO 14971:2012
  • Must have led teams in the development of Device Risk Management Files
  • Participates on Merck teams supporting MDCP CGMP and quality issues related to pure medical devices and the device constituent of a combination product
  • Works with the External and Internal Partners to ensure that effective and robust MDCP Quality Systems and Quality management are in place
  • Remains informed of current GMP requirements and industry trends as described in worldwide regulations and industry standards
  • Maintains an expert level of knowledge related to a specialized area of expertise
  • Led development and maintenance of Device Risk Management files
  • Extensive knowledge of medical device regulations (21CFR820)
  • Demonstrated ability to work effectively in teams
  • Ability to work in a high matrix organization
  • Effective written and oral communicator
  • Able to speak up and contribute in a team forum
  • Able to apply prior experiences and learning in new settings, even if these are unfamiliar
  • Knowledge of current GMPs for combination products
  • Quality Assurance and Regulatory Compliance experience is a plus
19

Associate Director, Medical Information Resume Examples & Samples

  • Lead and participate in the development and ongoing maintenance of Medical Information policies and procedures
  • Author standard response letters and contribute to evidence-based submission packages as a subject matter expert
  • Directly and independently handle unsolicited medical inquiries escalated to Kite Medical Information
  • Partner with Pharmacovigilance and Quality Departments to ensure AEs and PCs are captured and triaged in a timely and compliant manner
  • Utilize expertise and functional knowledge of the literature to collaboratively and effectively work within cross-functional teams to provide scientific input into the development strategy of Kite Pharma investigational therapies
20

Associate Director Medical Information Resume Examples & Samples

  • 8-10 years of related work experience
  • Experience managing vendors and complex projects is required
  • Focus on accountability and ownership – constantly challenging oneself to take responsibility for continuous performance improvement and operational excellence
  • Good business acumen including budget and resource planning and management
21

Associate Director, Medical Information Resume Examples & Samples

  • Directs and ensures successful completion of Medical Information operational objectives (eg., product launch preparedness and expansion of value-add services in support of Medical Affairs, Medical Science Liaisons, Sales Training and Development, Commercial) and provides medical, scientific and technical support for assigned product portfolio and/or products under clinical development; Ensures alignment of Medical Information activities with Clinical Research & Medical Affairs through development of comprehensive Medical Information plan and communication lines. – 40%
  • Evaluates cost benefit outcomes of implementing innovations in quality control mechanisms, supportive systems/databases, efficient inquiry handling work-streams, and overall dissemination of and access to scientific information (eg., Web 2.0, Health and Social Media platforms, enhancements to MedicaI Information Website, etc.). Contributes to the Medical Information strategy by directing the implementation of said innovations. Working closely with IT and other business partners to deliver digital technology enhancements (eg. Veeva, PhactMI, AuthorIT) and represent the MI group on related subcommittees. – 25%
  • Oversees the project management, timely development and internal review of pre-launch medical information resource documents; provides guidance to Medical Information Specialists/Managers regarding the content and structure of responses to ensure information is scientifically balanced and contains the appropriate disclosures/risk information; responsible for collaborating with cross-functional colleagues to resolve issues raised by the multi-disciplinary review team (eg., Medical Information Working Group) – 15%
  • If applicable, manages assigned resources: (a) Personnel – to ensure alignment with operational objectives, excellence in execution, and maintenance of quality performance; (b) budget – to ensure alignment with functional objectives, resource allocation and fiscal goals; Develops and updates related departmental SOPs and work-streams - 10%
  • Leads key training and development activities for self and direct reports to ensure access to high-level scientific and medical knowledge, appropriate legal and regulatory requirements, Codes of Practice, and corporate policies/procedures; provides mentorship to direct reports to support their professional and personal development
  • Minimum of a bachelor’s degree in pharmacy, nursing, or related life or information technology science. Advanced degree in related science (PharmD, MD, PhD etc.) and/or information technology/computer sciences is preferred
  • Minimum of 5 - 8 years within the pharmaceutical industry or related field. Experience in medical writing and support of product launch required. Experience in a customer-facing role such as Medical Information, Medical Education, Medical Science Liaison, and/or Scientific Communications is preferred
  • Demonstrated experience in Web 2.0, health information technology, and/or other emerging technologies with a firm grasp of the legal and cultural issues surrounding the application of Web 2.0 technologies and platforms including blogs, wikis, RSS feeds, social communities, microblogging, virtual worlds, social networks, etc
  • Organizational and planning skills, be detail-oriented
  • Proficiency with PC based applications, including Microsoft Word, Excel and PowerPoint
  • Highly self-motivated and able to handle multiple-tasks in a timely
  • Excellent project management and time management skills
  • Analytical, solutions-oriented, negotiation and strategic-thinking skills
22

Associate Director Medical Clinical Operations Resume Examples & Samples

  • The Associate Director will work cross - functionally in collaboration with operations, reporting, analytics and finance to support the execution of the program
  • Work with reporting to monitor Optum performance at the health plan level with presentation of results at monthly business reviews with regional leaders and health plan leaders
  • There will be accountability for partnering on all custom / non-standard requests made by the health plan and they will need to represent care management during state audits
  • Support direct and indirect reports and provide them with ongoing developmental opportunities and mentoring / coaching
  • Identifying and driving affordability opportunities within the health plan
  • Bachelor's Degree or higher
  • 3+ year’s health plan or clinical care management with progressive operational experience
  • 2+ years of management experience with Manager / Supervisor level clinical program oversight
  • Demonstrated experience building trusted business relationships
  • Demonstrated ability to prioritize deliverables, interpret data, operate strategically and execute end to end process
  • Excellent analytical skills - demonstrate use of analytics based decision making skills
  • Strong communication, interpersonal and presentation skills
  • Ability to manage change and difficult issues and drive resolution across team
  • Ability to execute effectively on end to end processes
  • Experience working within matrix organization
  • Proficient with Microsoft Word, Excel, Outlook & PowerPoint
  • Less 25% travel, quarterly to other market at minimum