Associate Director, Medical Writing
Yesterday
đĄ Remote â Anywhere in California
Description
⢠Independently author key regulatory and scientific documents or oversee external writers ⢠Lead planning, authoring, and critical review of regulatory documents as required ⢠Contribute to the strategic planning, authoring, and critical review of scientific data disclosures ⢠Engagement with external stakeholders such as contract writers, vendors, or key opinion leaders ⢠Develop and manage timelines for authoring, review and finalization of critical documents ⢠Function as an independent member of the team and represent Clinical Research / Medical Affairs ⢠Other duties related to clinical development of EFX or medical affairs initiatives as assigned
Requirements
⢠Advanced scientific degree in the life sciences (MS or PhD) with 5 years or more direct biotechnology or pharmaceutical industry experience in medical writing ⢠Prior experience with preparation of clinical protocols, clinical study reports, IB, briefing documents required ⢠Experience with authoring IND, NDA/BLA/CTD documents or RFI responses highly desirable ⢠Experience with preparation and submission of posters and peer-reviewed publications is a plus ⢠Familiarity with hepatology, gastrointestinal, or endocrinology therapeutic area preferred
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