Principal Scientist I/II, Study Quality and Compliance - Nonclinical Safety/Toxicology
$119,700–$222,300 year
On-siteCambridge, Massachusetts, United States
Cambridge, Massachusetts, United StatesOn-siteFull Time$119,700–$222,300 yearSenior LevelDoctorate Or Professional DegreeEnterprise
Full TimeSenior LevelDoctorate Or Professional DegreeEnterprise
Job Summary
Oversee periodic review and maintenance of Study Quality and Compliance SOPs, ensuring training records, CVs, and job descriptions align with GLP requirements. Support health authority inspections and internal audits by maintaining accurate departmental documentation. Coordinate with Archive Records Management for transferring GLP and non-GLP study records and materials between locations. Provide quality review and creation support for SEND packages for FDA submissions. Manage study-related information across various workstreams and initiatives.
Required Qualifications
- Degree in biological related sciences
- 8+ years of relevant experience working in a pharmaceutical setting
- Experience working in GLP setting
- general regulatory compliance and animal welfare knowledge related to conduct of toxicology studies
- Good communication skills
- excellent logistical/planning skills
- Fluent in English (spoken and written)
Desired Qualifications
- Previous experience with SEND packages is desirable
- Previous experience with software for online information and program management is a plus
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