Manager, Nonclinical Writing

Role: Nonclinical Writing Manager supporting early and late-stage drug development submissions, focusing on nonclinical content for global regulatory filings. Responsibilities: lead preparation of nonclinical protocols, reports, Investigator’s Brochures, INDs, IMPDs, annual reports, and NDA/MAA documents; manage document review cycles, timelines, and outsource writing staff; develop SOPs and templates; review internal/external publications; provide training on writing standards; ensure quality control of regulatory documents. Requirements: Bachelor's in Life Sciences, 4+ years’ experience, in-depth knowledge of FDA regulations, ICH guidelines, GxP, and drug development process; strong project management, writing, editing, and communication skills; proficiency in Microsoft Office; experience with regulatory submissions preferred. High-Value: supporting global regulatory filings, nonclinical content, early and late-stage programs, GxP compliance, cross-department collaboration. WorkSetup: hybrid in Cambridge, MA, with onsite presence aligned to team needs.