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.

The Impact You’ll Have

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.

As a Director, we also expect our leaders to demonstrate the following Leadership Competencies:

Leadership Competencies

Communication and Influence
Builds communication channels across Maze for sharing information
Influences Senior Management decisions through persuasive arguments
Respectfully addresses differing opinions leading to support of decision
Teamwork and Collaboration
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
Execution and Results
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
Develop Others and Self
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

What We’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.