Director, Medical Writing

Role: Director of Medical Writing supporting clinical regulatory documentation for Summit’s oncology programs, including Phase 3 trials in NSCLC and CRC. Responsibilities: prepare, edit, finalize protocols, CSRs, Investigator’s Brochures, briefing documents, and regulatory submissions; coordinate with cross-functional teams; manage review timelines; develop processes and templates to ensure high-quality, compliant deliverables. Requirements: BA/BS in a scientific field; 10+ years of regulatory medical writing experience in pharma, with proficiency in clinical study protocols, reports, and IND/NDA content; knowledge of oncology preferred. Skills: excellent scientific writing, attention to detail, multitasking, communication, ability to synthesize complex data; proficient in MS Office, Adobe, document management systems; capable of operating independently in a fast-paced environment. High-Value: oncology (NSCLC, CRC), Phase 3 clinical development, regulatory document preparation, cross-functional collaboration, experience with IND/NDAs. WorkSetup: not specified, but implied to be within a setting requiring close collaboration with clinical, biometrics, and regulatory teams.