Group Leader – Study Support Specialist (GLP studies – Product Safety Labs)
Core
Lead a team of support staff to manage GLP-compliant preclinical safety studies, ensuring data quality, regulatory compliance, and on-time delivery for toxicology and product safety labs.
Role type
Senior Group Leader, Study Support Specialist (Toxicology/Preclinical Safety)
Builds
GLP-compliant study documentation, data packages, and regulatory submissions for pharmaceutical and life sciences clients
Domain
Life Sciences / Preclinical Toxicology / Regulatory Affairs
Required skills
Team leadership, GLP compliance, study protocol management, data quality control, regulatory filing knowledge, technical writing, risk management, logistics coordination, cross-functional communication, process improvement
Preferred skills
Toxicology background, advanced degree (M.S./Ph.D.), IND enabling study experience, preclinical trial management
Technologies
GLP study management systems, document control systems, chain-of-custody tracking tools
Responsibilities
Manage and mentor a team of 4-5 support staff; coordinate study initiation, resource planning, and logistics; conduct quality control reviews of laboratory data and records; monitor study milestones and critical path activities; prepare and review study protocols and amendments; maintain audit-ready study documentation; support study Directors with scheduling and cross-functional communication; compile study data packages for reporting and regulatory inspection; track deviations and data requests; participate in process improvement initiatives.
Seniority
Senior, hands-on IC with team leadership
