Director, Medical Writing
External job listingat Maze Therapeutics
Lead medical writing at Maze Therapeutics, overseeing clinical and regulatory documents and partnering across development programs.
Salary
Not provided
Location
South San Francisco, United States
Employment type
Full time
Workplace
Not provided
Director, Medical Writing
South San Francisco, United States
Job description
About the role
Maze Therapeutics is seeking a Director, Medical Writing to lead its medical writing function and support the development of clinical and regulatory documents across its development programs. Reporting to the Vice President of Regulatory and Quality Science, this role works with cross-functional and external partners to advance planning, development, and readiness of clinical and regulatory deliverables. The role also manages Regulatory Operations and Regulatory Project Management resources.
Responsibilities
- Lead the medical writing function and oversee 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 deliver timely, high-quality work aligned with Maze’s scientific, clinical, and regulatory expectations.
- Ensure documents are internally consistent and reflect agreed program strategy, study objectives, clinical data, and health authority expectations.
- Partner with Regulatory Affairs, Clinical Development, Biostatistics, Clinical Operations, Safety, Quality, CMC, and external partners on clinical-regulatory deliverables.
Key facts
- The role is with Maze Therapeutics.
- The position is in South San Francisco, United States.
- The role leads medical writing across Maze’s development programs.
- The role manages Regulatory Operations and Regulatory Project Management resources.
Frequently asked questions
What does the Director, Medical Writing role involve?
It leads the medical writing function and development of clinical and regulatory documents across Maze’s development programs.
What documents are included in the role?
Examples include protocols, clinical study reports, health authority meeting materials, and submission-supporting content.
Which teams does the role work with?
The role partners with Regulatory Affairs, Clinical Development, Biostatistics, Clinical Operations, Safety, Quality, CMC, and external partners.