Associate Director, Medical Writing

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Akero Therapeutics

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Restoring Balance. Renewing Life.

11 - 50

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