Job Description
- Job Description:
- 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:
- 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:
- company paid healthcare
- flexible spending accounts
- voluntary life insurance
- 401K matching
- uncapped vacation
Apply tot his job
Apply To this Job