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
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
ABOUT IAMBIC THERAPEUTICS
MISSION & CORE VALUES
PAY AND BENEFITS
Benefits
Health insurance401(k)Paid time offFlexible schedule
Additional Information
JOB SUMMARY
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.
Iambic-therapeutics · Remote