6903 Associate Director, Medical Writing
The Associate Director supports the Medical Communications regulatory writing function in alignment with the requirements of GMAF and organizational goals.
This is an emerging leadership position in Medical Communications with substantial strategic input across GMAF for assigned product(s) or therapeutic area(s).
The Associate Director will focus on shaping and defining medical writing activities for assigned products, including synthesizing stakeholder input, ensuring alignment cross-functionally, and conducting gap analyses for defining the writing strategy.
The Associate Director will also lead content creation activities including oversight of contract writers and ensure compliance with all Company standard operation procedures.
This position may be responsible for supporting Medical Communications functional leadership activities including managing staff, budgets, and departmental activities.
Responsibilities may include, but are not limited to:
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.
Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures and periodic study reports.
Drafts and edits clinical summary documents (Modules 2.5 and 2.7) used in NDA/BLA filings that conform to ICH CTD structure.
Provides peer review and editing support for other regulatory documents such as response documents and briefing packages.
Manages study team participation in the preparation of such documents, including calling/running meetings and managing the document review and comment adjudication processes.
Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
Participates in providing oversight of external medical writing vendors and contributing to the development of documents.
Works effectively in a highly cross-functional environment.
Establishes and maintains effective cross-functional communication, including with key Study Management, Clinical, Commercial, and Regulatory counterparts and stakeholders.
Establishes relationships with healthcare professionals/authors/investigators.
Supports Medical Communications group in the management of departmental workflow and deliverables.
Assists Director of Medical Communications to forecast and secure resources for document development.
Other tasks as assigned.
Experience with writing and editing protocols, clinical study reports, and CTD clinical summary modules highly preferred.
Intermediate to advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents that prescribe content.
Intermediate to advanced applied knowledge of AMA, CBE, and Chicago Style Manuals.
Ability to interpret basic tabular and graphical clinical data presentations.
Ability to create basic tables using AMA style (eg, Schedule of Events).
Intermediate applied knowledge of basic clinical laboratory tests.
Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).
Basic understanding of biostatistical and clinical research concepts.
Intermediate knowledge of regulatory requirements and guidance associated with ‘standalone’ regulatory documents (eg, protocols, investigator brochures, and clinical study reports).
Familiar with the drug development process (discovery to market), clinical study protocol design and study conduct, and documentation required for the conduct of clinical studies.
Familiar with clinical study data collection and results reporting.
Computer/Office Equipment Skills
Proficient in Microsoft Word (including the use of templates), Excel, PowerPoint, and Project. Experienced with scanners, printers, and copiers.
Capable of working on multiple tasks and shifting priorities.
Capable of leading a cross-functional team under strict timelines, including calling/running meetings and managing team review and comment adjudication stages of document preparation.
Good conflict management skills.
Motivated and shows initiative.
Capable of well organized, concise and clear written and verbal communication.
Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements.
Effective at explaining writing principles to a varied audience both in individual and group settings; intermediate presentation skills.
BA/BS in life or health sciences; advanced degree (MS or doctoral) preferred.
5 or more years of experience as a medical writer in the pharmaceutical industry.
8 or more years of medical or scientific writing experience as a primary job responsibility.
Evidence of medical writing career development desirable, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.