Director/Senior Director, Medical Writing

Director/Senior Director, Medical Writing

We are a clinical‑stage immunology company focused on developing and commercializing small molecule therapies.

The Role

The Director/Senior Director, Medical Writing will lead all aspects of medical writing for our NDA program, including the authoring of regulatory documents and overseeing external medical writing consultants and vendors.

Candidate Requirements

• Advanced degree in a life science or health‑related field (Ph.D., Pharm.D., M.S., or equivalent)
• Minimum of 12 years of medical writing experience in the pharmaceutical or biotech industry
• Proven experience in leading or playing a key role in NDA submissions (required)
• Expertise in authoring regulatory documents in compliance with ICH and FDA guidance
• Previous experience in NDA authoring as an individual contributor and as a manager of authors.
• Domestic travel up to 10% may be necessary

Nice‑to‑Haves

• Experience working in a startup environment

Compensation

Title and compensation will be commensurate with candidate experience. We offer a competitive base, annual bonus, and equity.

Job Details

Seniority level: Director

Employment type: Full‑time

Job function: Quality Assurance, Research, and Manufacturing

Industries: Biotechnology Research, Pharmaceutical Manufacturing, and Research Services

Benefits

Medical insurance

Vision insurance

401(k)

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