About this role
About the Role The individual will provide scientific and operational support to Study Quality and Compliance group within the Toxicology line function of Preclinical Safety (PCS). The role includes maintaining training records, CVs, and JDs for PCS, supporting health authority inspections, and coordinating with Archive Records Management for transfer of GLP and non-GLP study records. Experience with SEND (Standard for Exchange of Nonclinical Data) packages for creation and QC of datasets is a plus. What You'll Do
- Oversee periodic review and maintenance of PCS SOPs, gather stakeholder input, and maintain awareness of company SOPs that influence PCS.
- Ensure PCS compliance with training records, CVs, and JDs; ensure the process aligns with GLP requirements.
- Support Archives Record Management (ARM) by collating listings of studies with records and materials archived at CRO study sites; coordinate ARM transfers to permanent archiving locations.
- Support SEND package creation and quality review for FDA submissions.
- Support the Study Quality and Compliance team’s efforts for tracking and managing study-related information, and assist across various workstreams or initiatives. What We're Looking For
- Degree in biological related sciences.
- 8+ years of relevant pharmaceutical experience.
- Experience in GLP settings, regulatory compliance, and animal welfare knowledge related to toxicology studies.
- Good communication and excellent logistical/planning skills.
- Fluent in English (spoken and written). Nice to Have
- Previous experience with SEND packages.
- Previous experience with software for online information and program management. Compensation & Benefits
- Salary range: $119,700 – $234,000 per year (USD).
- Final salary offered will be determined based on skills and experience.