Principal Scientist I/II, Study Quality and Compliance - Nonclinical Safety/Toxicology
Core
Ensure study quality and compliance for nonclinical safety/toxicology studies, manage SOPs, training records, and archive transfers.
Role type
Senior IC study quality and compliance scientist (nonclinical safety)
Builds
Regulatory-compliant toxicology study documentation and archive records
Domain
Pharmaceutical nonclinical safety/toxicology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GLP compliance, regulatory compliance, animal welfare knowledge, SOP management, archive record management, SEND package creation, study quality tracking
Preferred skills
SEND package creation, online information and program management software
Technologies
SEND
Responsibilities
Oversee periodic review and maintenance of PCS SOPs; ensure compliance with training records, CVs, and JDs; support Archives Record Management for study transfers; support SEND package creation and quality review for FDA submissions; track and manage study-related information
Seniority
Senior, hands-on IC
