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

Bachelor’s degree required; advanced degree (PhD, PharmD, MD) preferred
15+ years of experience in biotech/pharma, with 10+ years in medical writing, prior experience in smaller or growing biotech environments preferred
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

Head of Medical Writing

Key skills