Maze Therapeutics
Director, Medical Writing
South San Francisco, CA · Director
Sponsorship not specifiedDetected 1 day ago
Project ManagementFDA RegulatoryLeadershipCommunicationCollaborationBiostatisticsRegulatory Affairs
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.
Responsibilities
- Builds communication channels across Maze for sharing information
- Respectfully addresses differing opinions leading to support of decision
- Maintains a steadying presence and clarifies priorities during change
- Develop Others and Self
- Removes barriers to staff development and empowers them to make their own decisions
- Partner closely with Regulatory Affairs, Clinical Development, Biostatistics, Clinical Operations, Safety, Quality, CMC, and external partners to support development and finalization of clinical-regulatory deliverables.
Requirements
- Strong understanding of drug development, clinical trial design, regulatory requirements, and FDA, ICH, EMA, and other applicable guidance for clinical-regulatory documents.
Nice to have
- sponsor-side or sponsor-embedded experience 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.
Benefits
- Manage medical writing vendors and external partners to ensure timely, high-quality deliverables that are aligned with Maze's scientific, clinical, and regulatory expectations.
- Ensure clinical and regulatory documents are internally consistent and appropriately reflect agreed program strategy, study objectives, clinical data, and health authority expectations.
- Establish and improve medical writing standards, templates, review practices, and process efficiencies to support scalable, high-quality regulatory document development.
Visa & Work Authorization
- 8–10+ years of progressive regulatory medical writing experience in the biopharmaceutical industry; sponsor-side or sponsor-embedded experience preferred
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This listing is sourced directly from Maze Therapeutics's careers page and normalized into a canonical job model.