Director, Medical Writing

About the role

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.

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 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.

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.

Qualifications

• Advanced degree in a scientific, medical, or health-related discipline preferred; bachelor’s degree with significant relevant experience required.
• 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.

Skills

• Strong communication and influence skills.
• Excellent teamwork and collaboration abilities.
• Effective execution and results orientation.
• Ability to identify and implement opportunities to improve efficiency, quality, and regulatory readiness.
• Leadership and management experience.

Benefits

• Competitive medical, dental, and vision insurance.
• Mental health offerings.
• Equity incentive plan.
• 401(k) program with employer match.
• A generous holiday and PTO policy.

Pay

The expected annual salary range for employees located in the San Francisco Bay Area is $223,000 - $271,000. Additionally, this position is eligible for an annual performance bonus. Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location.

Schedule

Maze offers a flexible schedule to accommodate the needs of our employees.