Backed by GV.
About the role
This is a hands-on, individual-contributor role responsible for authoring and coordinating high-quality regulatory and clinical documents in support of the company's oncology development programs. This role partners closely with the SVP, Development and Regulatory Strategy and cross-functional teams (Clinical, Biostatistics, Nonclinical, CMC, Regulatory) to prepare, format, and QC, submission-ready clinical and regulatory documents across the product lifecycle.
What they're looking for
- Bachelor's degree in life sciences required, advanced degree (PhD, PharmD, MS) strongly preferred
- 8+ years of regulatory/medical writing experience, with a significant portion in oncology drug development
- Direct, hands-on experience authoring clinical and regulatory oncology submissions and/or amendments
- Experience supporting responses to health authority inquiries (FDA and/or ex-US agencies), including briefing documents for regulatory meetings
- Strong knowledge of ICH guidelines (E3, E6, M4/CTD format) and regulatory document standards
- Excellent scientific writing skills with the ability to synthesize complex clinical and nonclinical data into clear, accurate, well-organized documents
More about this role
This is a hands-on, individual-contributor role responsible for authoring and coordinating high-quality regulatory and clinical documents in support of the company's oncology development programs. This role partners closely with the SVP, Development and Regulatory Strategy and cross-functional teams (Clinical, Biostatistics, Nonclinical, CMC, Regulatory) to prepare, format, and QC, submission-ready clinical and regulatory documents across the product lifecycle.
The ideal candidate is a strong, independent oncology medical writer who is comfortable owning documents end-to-end — from outline through final QC. The specific title and level will be determined based on the selected candidate's depth of oncology and regulatory writing experience. We are seeking someone with 8+ years of regulatory/medical writing experience, with substantial oncology medical writing experience. The candidate should be able to execute documents independently with appropriate input from subject matter experts and should feel comfortable developing and refining templates, style guides, and medical writing best practices as the function matures. As needed, the candidate should also be comfortable coordinating...
Browse similar: Startup jobs