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Maze Therapeutics is seeking a Director of Medical Writing to lead the medical writing function and drive the development of high-quality clinical and regulatory documents across the company's precision medicine development programs. Reporting to the Vice President of Regulatory and Quality Science, you will be accountable for the strategic planning, development, and submission-readiness of clinical study reports, protocols, health authority meeting materials, and regulatory submission-supporting content.
Key responsibilities include leading the medical writing function with accountability for document quality, scientific accuracy, internal consistency, and alignment with program objectives. You will manage medical writing vendors and external partners to ensure timely, high-quality deliverables that meet Maze's scientific, clinical, and regulatory standards. Additionally, you will oversee Regulatory Operations and Regulatory Project Management resources that support the company's development programs.
You will work closely with cross-functional teams including clinical development, regulatory affairs, quality assurance, and external partners to advance planning and readiness of clinical and regulatory deliverables. The role requires expertise in developing submission-ready documents, understanding regulatory pathways, and ensuring compliance with health authority requirements.
This is a pivotal position where you will directly impact Maze's ability to advance precision medicines for patients with severe diseases. The ideal candidate brings deep experience in medical writing within a biotech or pharmaceutical setting, strong leadership capabilities, vendor management expertise, and a track record of delivering high-quality regulatory documents that support successful submissions.
