Senior Medical Writer
Eli Lilly and Company
September 09, 2026
Full-time
Remote friendly (Indiana, United States)
Worldwide
Clinical Research and Development
Role: Senior Medical Writer supporting clinical regulatory documentation for Centessa Pharmaceuticals' neurodevelopmental asset portfolio, including orexin receptor agonists for narcolepsy and sleep disorders. Responsibilities: author and manage clinical study documents (protocols, Investigator Brochures, CSRs), collaborate with Clinical Development, Regulatory Affairs, Biostatistics, and other teams; oversee document lifecycle from draft to review and finalization, ensuring compliance with GCP, ICH, eCTD, and company standards; interpret complex clinical data and contribute to SOP development. Requirements: PhD or advanced degree in a scientific or clinical discipline; 4+ years in pharmaceutical medical writing with at least 2 years in sponsor-level roles; neuroscience experience preferred; strong organizational, communication, and regulatory knowledge, including global trial submission requirements (FDA, EMA, PMDA). High-Value: clinical/regulatory writing, neurotherapeutics, sleep disorder indications, development stage (clinical), GCP/ICH compliance, cross-functional collaboration, familiarity with document management platforms (e.g., Veeva Vault). WorkSetup: not specified.