Head of Medical Writing - Remote

Overview

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.

In Short

• Lead the planning, authoring, and delivery of key development documents.
• Provide strategic input on document content and regulatory expectations.
• Partner cross-functionally with various teams.
• Establish and refine medical writing processes and standards.
• Implement and manage efficient document workflows.
• Support development of abstracts and presentations for conferences.
• Evaluate and integrate AI tools to enhance writing quality.
• Manage external vendors and build internal capabilities.
• Ensure consistency and quality across all deliverables.
• Advise on regulatory communication strategy.

Requirements

• Bachelor’s degree required; advanced degree preferred.
• 15+ years in biotech/pharma, with 10+ years in medical writing.
• Strong experience with IND submissions.
• Strong scientific writing and editing skills.
• Understanding of FDA/EMA regulations and ICH guidelines.
• Ability to lead document development in a lean environment.
• Comfortable balancing strategic input with execution.
• Interest in applying AI tools in workflows.

Benefits

• Industry leading competitive pay.
• Company paid healthcare.
• Flexible spending accounts.
• Voluntary life insurance.
• 401K matching.
• Uncapped vacation.
• State-of-the-art facility in San Diego.
• Onsite gym and dining.
• Easy access to great places to live and play.