Principal Scientist I/II, Study Quality and Compliance - Nonclinical Safety/Toxicology

Role: Principal Scientist I/II supporting Study Quality and Compliance within Preclinical Safety Toxicology. Responsibilities include maintaining SOPs, ensuring GLP compliance of training records, CVs, JDs, supporting inspections, and coordinating archive record transfers, including SEND package support for FDA submissions. Requirements: Degree in biological sciences, 8+ years in a pharma setting with GLP experience, regulatory compliance, and animal welfare knowledge. Good communication and planning skills are essential. Preferred: Experience with SEND datasets and online program management. High-Value: Focus on toxicology studies, GLP compliance, regulatory support, and quality oversight. Work setup: Hybrid in Cambridge MA; no travel specified.