Head of Medical Writing
About The Position
The Head of Medical Writing (Senior Director) will lead and build the medical writing function, reporting to the VP of Regulatory. This role will be responsible for delivering high-quality submission-ready development documents to support ongoing clinical-stage programs and upcoming IND submissions, while establishing fit-for-purpose, scalable processes and standards. The ideal candidate is both strategic and hands-on, with the ability to drive document development and address global program objectives while also building infrastructure for future growth, including the thoughtful integration of AI-enabled tools.
Requirements
- Bachelor’s degree required
- 15+ years of experience in biotech/pharma
- 10+ years in medical writing
- Strong experience supporting IND submissions and clinical-stage programs
- Strong scientific writing and editing skills, with attention to detail
- Solid understanding of FDA/EMA regulations and ICH guidelines
- Ability to lead cross-functional document development in a lean environment
- Comfortable balancing strategic input with hands-on execution
- Interest in applying AI tools to improve medical writing workflows
Nice To Haves
- advanced degree (PhD, PharmD, MD) preferred
- prior experience in smaller or growing biotech environments preferred
Responsibilities
- Lead the planning, authoring, and delivery of key development documents (INDs, protocols, IBs, CSRs, Health Authority responses, briefing documents, etc)
- Provide strategic input on document content, messaging, and regulatory expectations
- Partner cross-functionally with Clinical, Nonclinical, Medical, Biostats, CMC, and Regulatory teams
- Establish and refine medical writing processes, templates, and standards
- Implement and manage efficient document workflows and timelines
- Support development of abstracts, posters, and presentations for scientific conferences
- Evaluate and integrate AI tools to enhance writing quality and efficiency
- Manage external vendors and contribute to building internal capabilities over time
- Ensure consistency, quality, and accuracy across all deliverables
- Advise cross-functional leadership on regulatory communication strategy and global document planning
Benefits
- company paid healthcare
- flexible spending accounts
- voluntary life insurance
- 401K matching
- uncapped vacation
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
