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