Director, Medical Writing
About The Position
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.
Requirements
- 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.
- 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.
Responsibilities
- Lead the medical writing function and be accountable for the development of high-quality clinical and regulatory documents across Maze’s development programs, including protocols, clinical study reports, health authority meeting materials, and submission-supporting content.
- 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.
- 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.
- Interpret and translate clinical study source materials, including protocols, SAPs, TFLs, and safety and efficacy outputs, into clear, accurate, and defensible regulatory documents with appropriate cross-functional input and alignment.
- Establish and improve medical writing standards, templates, review practices, and process efficiencies to support scalable, high-quality regulatory document development.
- Identify practical opportunities to use structured content, content reuse, automation, and AI-enabled tools to improve efficiency, quality, consistency, and regulatory readiness while maintaining appropriate human oversight and traceability.
- Builds communication channels across Maze for sharing information
- Influences Senior Management decisions through persuasive arguments
- Respectfully addresses differing opinions leading to support of decision
- Champions partnerships and connections across Maze
- Proactively addresses issues that could result in breakdown of team relationships
- Spotlights team and individual contributions in public forums
- Addresses gaps and leverages strengths to get best results
- Maintains a steadying presence and clarifies priorities during change
- Anticipates and removes barriers that put functional/corporate goals at risk
- Removes barriers to staff development and empowers them to make their own decisions
- Stays current on industry trends and keeps direct-reports prepared and responsive
Benefits
- competitive medical, dental, and vision insurance
- mental health offerings
- equity incentive plan
- 401(k) program with employer match
- generous holiday and PTO policy
- annual performance bonus
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What This Job Offers
Job Type
Full-time
Career Level
Director
