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