Principal Scientist I/II, Study Quality and Compliance - Nonclinical Safety/Toxicology
About The Position
The individual will provide scientific and operational support to the Study Quality and Compliance group within the Toxicology line function of Preclinical Safety (PCS). Key areas of responsibility or oversight include ensuring training records, CVs, and Job Descriptions (JDs) for all of PCS are appropriately maintained and on file, as well as periodic review and maintenance of departmental SOPs. With respect to these items, provide support to health authority inspections and internal inspection-readiness audits. This person will also be responsible for coordinating with the Archive Records Management function for the transfer of GLP and non-GLP study records and materials from one archive location to another. The ideal candidate would also have experience with SEND (Standard for Exchange of Nonclinical Data) packages to provide support for both creation and QC of these datasets.
Requirements
- Degree in biological related sciences
- 8+ years of relevant experience working in a pharmaceutical setting
- Experience working in GLP setting, and general regulatory compliance and animal welfare knowledge related to conduct of toxicology studies
- Good communication skills, and excellent logistical/planning skills
- Fluent in English (spoken and written)
Nice To Haves
- Previous experience with SEND packages is desirable
- Previous experience with software for online information and program management is a plus
Responsibilities
- Oversee periodic review and maintenance of PCS SOPs, garnering necessary stakeholder input and having good working knowledge of any company SOPs that influence or impact the PCS SOPs.
- Be responsible for ensuring PCS compliance with training records CV, and JDs, and ensure the process for doing so is consistent with GLP requirements.
- Support Archives Record Management (ARM) function, by collating a listing of all studies that have records and materials archived at CRO study site.
- Coordinate the ARM transfers to permanent archiving locations.
- Support SEND package creation and quality review for FDA submissions
- Support the Study Quality and Compliance team’s effort for tracking and managing study-related information through input of information types from the areas of responsibility above and generally support the effort in various workstreams or initiatives.
Benefits
- health, life and disability benefits
- a 401(k) with company contribution and match
- a variety of other benefits
- a generous time off package including vacation, personal days, holidays and other leaves
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What This Job Offers
Job Type
Full-time
Career Level
Senior
