Manager, Nonclinical Writing

Role: Manager of Nonclinical Writing supporting regulatory submissions within biopharma, focusing on early development and late-stage programs. Responsibilities: lead nonclinical content creation and review for regulatory documents (e.g., protocols, reports, INDs, NDA/MAA filings), manage timelines and review cycles, coordinate with scientific teams, edit and interpret nonclinical data, review external publications, oversee outsourced writers, contribute to SOPs and style guides, and ensure quality control. Qualifications: Bachelor's in Life Sciences with 4+ years' relevant experience; knowledge of GLP, FDA regulations, ICH guidelines, and drug development; strong project management, attention to detail, and communication skills; proficient in Microsoft Office; experience with regulatory submissions a plus. High-Value: focus on nonclinical documentation supporting global regulatory filings, early and late-stage development, within a hybrid role based in Cambridge, MA.