Senior Nonclinical Documentation Associate

Role: Senior Documentation Associate supporting nonclinical writing and documentation within biopharma, focusing on quality review, publishing, and archiving of nonclinical study reports. Responsibilities: ensure document formatting and regulatory compliance, manage document workflows, perform quality control checks, provide training, and support departmental systems and initiatives. Requirements: Bachelor's in a relevant scientific or technical field; 4+ years in biotech/pharma or CRO with experience in document QC, electronic publishing, and document management; proficiency in MS Office, Adobe Acrobat, and familiarity with regulatory standards such as 21 CFR Parts 11, 58, 312, 314, OECD, ICH, eCTD, SEND. Preferred: experience with electronic document systems, StartingPoint templates, SharePoint, and AI tools; detail-oriented with problem-solving skills and ability to manage multiple projects in a fast-paced environment. HighValue: nonclinical regulatory documentation, GxP compliance, controlled environment experience, Cambridge, MA hybrid work setup.