Head of Medical Writing

Leading the medical writing function, the full-time Head of Medical Writing will manage the planning and delivery of key development documents for clinical-stage programs while establishing scalable processes and integrating AI tools, all in a remote work environment.
Key Responsibilities

Lead the planning, authoring, and delivery of key development documents such as INDs, protocols, and CSRs
Provide strategic input on document content and regulatory expectations while partnering cross-functionally with various teams
Establish and refine medical writing processes, templates, and workflows to ensure quality and efficiency

Required Qualifications

Bachelor's degree required; advanced degree (PhD, PharmD, MD) preferred
15+ years of experience in biotech/pharma, with 10+ years specifically in medical writing
Strong experience supporting IND submissions and clinical-stage programs
Solid understanding of FDA/EMA regulations and ICH guidelines
Interest in applying AI tools to improve medical writing workflows