Director, Medical Writing — Regulatory Strategy & Submissions

Lyell Immunopharma; United States; On-site; USD 220,000 - 240,000; Full time

Job summary

Lyell Immunopharma is seeking a Director of Medical Writing to build the function, author clinical regulatory documents, and guide outsourcing. You will own protocols, ISRs, and Module 2 content, while developing the drafting infrastructure and AI-assisted workflows.

Reporting to Regulatory Affairs, you will collaborate with Clinical Development, ensuring timely, regulator-ready submissions and inspection readiness in a lean team.

Qualifications

• 10+ years of medical writing in biotech or pharma, with substantial clinical regulatory experience.
• Lead-author depth on protocols, amendments, and Investigator's Brochures.
• Working knowledge of ICH E3, E6(R3), E2, M4E, CTD/eCTD structure, and 21 CFR requirements.
• Experience managing outsourced writing vendors: scoping, budgeting, quality oversight.

Responsibilities

• Lead protocols and amendments to regulator-ready text.
• Own Investigator's Brochure lifecycle including updates and changes.
• Author Clinical Study Reports to ICH E3 end-to-end with QC.

Skills

Medical writing

Vendor management

AI in writing

Regulatory writing

Education

Advanced degree

Job description

Lyell Immunopharma is seeking a Director of Medical Writing to build the function, author clinical regulatory documents, and guide outsourcing. You will own protocols, ISRs, and Module 2 content, while developing the drafting infrastructure and AI-assisted workflows.

Reporting to Regulatory Affairs, you will collaborate with Clinical Development, ensuring timely, regulator-ready submissions and inspection readiness in a lean team.