Director, Medical Writing
$223,000–$271,000 year
HybridSouth San Francisco, California, United States
Job Summary
Lead the medical writing function and drive the development of high-quality clinical and regulatory documents across Maze's development programs, including protocols, clinical study reports, and submission-supporting content. Manage medical writing vendors and external partners to ensure timely, high-quality deliverables aligned with scientific and regulatory expectations. Interpret clinical study source materials, such as protocols and safety outputs, into clear, accurate regulatory documents while establishing standards, templates, and process efficiencies. Partner closely with cross-functional teams to advance the planning and readiness of clinical-regulatory deliverables, leveraging structured content, automation, and AI-enabled tools to improve efficiency and quality.
Required Qualifications
- 8–10+ years of progressive regulatory medical writing experience in the biopharmaceutical industry
- Advanced degree in a scientific, medical, or health-related discipline
- Bachelor's degree with significant relevant experience
- Demonstrated experience with clinical and regulatory documents across the development lifecycle
- Late-stage development and NDA/BLA/MAA experience
- Strong understanding of drug development, clinical trial design, regulatory requirements, and FDA, ICH, EMA, and other applicable guidance for clinical-regulatory documents
- Ability to interpret and communicate clinical data clearly and accurately
- Experience working with protocols, SAPs, TFLs, safety and efficacy outputs, and other clinical study source materials
- Experience managing external medical writing resources
- Experience working effectively with cross-functional teams in a hands-on development environment
- Practical familiarity with structured content, content reuse, document automation, AI-enabled tools, or other technologies that can improve efficiency, consistency, and quality in medical writing
Desired Qualifications
- Sponsor-side or sponsor-embedded experience
- Experience with clinical and regulatory documents across the development lifecycle, with late-stage development and NDA/BLA/MAA experience preferred
- Strong understanding of drug development, clinical trial design, regulatory requirements, and FDA, ICH, EMA, and other applicable guidance for clinical-regulatory documents
- Ability to interpret and communicate clinical data clearly and accurately, including experience working with protocols, SAPs, TFLs, safety and efficacy outputs, and other clinical study source materials
- Experience managing external medical writing resources and working effectively with cross-functional teams in a hands-on development environment
- Practical familiarity with structured content, content reuse, document automation, AI-enabled tools, or other technologies that can improve efficiency, consistency, and quality in medical writing
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