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Head of Medical Writing
Iambic TherapeuticsLead medical writing team at Iambic Therapeutics, integrating AI tools for efficient document processes. Deliver high-quality regulatory submission documents for clinical-stage programs.
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- 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
Benefits
Comp & perks- company paid healthcare
- flexible spending accounts
- voluntary life insurance
- 401K matching
- uncapped vacation
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical writingscientific writingeditingdocument developmentIND submissionsclinical-stage programsregulatory communicationworkflow managementAI tools integrationattention to detail
Soft Skills
strategic inputcross-functional collaborationleadershipcommunicationproject managementproblem-solvingadaptabilityattention to detailexecutionvendor management
Certifications
Bachelor’s degreePhDPharmDMD