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About the Role

Lead the medical writing function and play a central role in the development of clinical and regulatory documents across Maze’s development programs. Ensure documents are scientifically accurate, internally consistent, fit for purpose, submission-ready, and aligned with program objectives. Partner closely with cross-functional and external partners to advance the planning, development, and readiness of clinical and regulatory deliverables. Manage Regulatory Operations and Regulatory Project Management resources.

Responsibilities

Lead the medical writing function and be accountable for the development of high-quality clinical and regulatory documents, 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 aligned with Maze’s 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 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.
Identify opportunities to use structured content, content reuse, automation, and AI-enabled tools to improve efficiency, quality, consistency, and regulatory readiness.

Requirements

8–10+ years of progressive regulatory medical writing experience in the biopharmaceutical industry; sponsor-side or sponsor-embedded experience preferred.
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.

Skills

Communication and Influence
Teamwork and Collaboration
Execution and Results
Develop Others and Self

Location

San Francisco Bay Area

Work Type

Hybrid

Experience Level

8-10+ years

Education Level

Advanced degree in a scientific, medical, or health-related discipline preferred
Bachelor's degree with significant relevant experience required

Salary/Compensations

$223,000 - $271,000
Eligible for an annual performance bonus

Benefits

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

About the Company

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.
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.
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.