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.
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.
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.
- 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.
About Maze Therapeutics
Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing human genetics to develop precision medicines for patients with kidney and metabolic diseases. Our clinical pipeline is anchored by two small molecule programs: MZE829, an APOL1 inhibitor for patients with APOL1-mediated kidney disease, and MZE782, which targets genetic drivers of disease in phenylketonuria (PKU) and chronic kidney disease. We are also advancing a preclinical pipeline through our Compass platform, which links human genetic variants to the biological pathways that drive disease.
Our People
Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients.
Our Core Values
- Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we’ll achieve our mission.
- Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others.
- Stand True – Our integrity is foundational; it guides us no matter the obstacle.
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. The expected salary range for this role may be modified in the future.
- competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy.
Director, Medical WritingSouth San Francisco, CA in south san francisco at Unknown Company
This position is listed as full time and onsite.