Backed by a16z and GV.
About the role
Step into a pivotal role where science meets strategy. At Maze, we’re on a mission to uncover genetic insights and transform them into precision medicines that change lives. Our team is driven by curiosity, collaboration, and a commitment to improving treatment for people with severe diseases. We thrive on diverse perspectives and bold ideas, and we’re looking for someone who shares that spirit.
What they're looking for
- 8–10+ years of progressive regulatory medical writing experience in the biopharmaceutical industry, sponsor-side or sponsor-embedded experience preferred
- Advanced degree in a scientific, medical, or health-related discipline preferred, bachelor’s degree with significant relevant experience required
- Demonstrated 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
More about this role
Step into a pivotal role where science meets strategy. At Maze, we’re on a mission to uncover genetic insights and transform them into precision medicines that change lives. Our team is driven by curiosity, collaboration, and a commitment to improving treatment for people with severe diseases. We thrive on diverse perspectives and bold ideas, and we’re looking for someone who shares that spirit.
As our Director of Medical Writing, you’ll lead the medical writing function and play a central role in the development of clinical and regulatory documents across Maze’s development programs. You’ll help ensure that documents are scientifically accurate , internally consistent, fit for purpose, submission-ready, and aligned with program objectives .
Reporting to the Vice President of Regulatory and Quality Science, you’ll work closely with cross-functional and external partners to advance the planning, development, and readiness of clinical and regulatory deliverables. You’ll also manage Regulatory Operations and Regulatory Project Management resources that support Maze’s development programs.
- Lead the medical writing function and be accountable for the development of high-quality...
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