Cynosure Staffing
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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