Head of Medical Writing

Job Summary

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