Principal Scientist - Toxicology
Core
Provide scientific and operational support to the Study Quality and Compliance group within PreClinical Safety, ensuring GLP compliance and managing study documentation for FDA submissions.
Role type
Principal Scientist - Toxicology (Quality & Compliance)
Builds
Regulatory-compliant study documentation and SEND packages for FDA submissions
Domain
Pharmaceutical preclinical safety and toxicology
Deliverable
client delivery
Required skills
Regulatory compliance, GLP standards, Animal welfare requirements, SEND package creation, Quality assurance, SOP maintenance, Electronic laboratory notebook compliance, Global study information management
Preferred skills
Software tools for online information and program management
Technologies
Electronic laboratory notebooks, Global online study management software
Responsibilities
Ensure PCS compliance with training records, CVs, and job descriptions; Maintain documentation consistency with GLP requirements; Support periodic review and maintenance of PCS SOPs; Create and perform quality checks on SEND packages for FDA submissions; Support electronic laboratory notebook compliance; Track and manage study-related information globally using software tools
Seniority
Senior, hands-on IC with strategic oversight
