Regulatory Affairs Specialist
1 week ago
Job Summary
The Perelman School of Medicine at the University of Pennsylvania seeks a highly skilled Regulatory Affairs Veeva Quality Assurance Specialist to join our Clinical Research Unit. As a key member of our team, you will be responsible for reviewing and migrating Phase I-V clinical trial investigator site files to the Veeva SiteVault platform.
Key Responsibilities
- Review and itemize regulatory documentation from the current document management system
- Migrate documents to the SiteVault platform, including person, organization, product, and study profiles
- Map existing data to unique Veeva data fields and assign metadata for new data fields
- Collaborate with the Veeva Quality Assurance Lead to ensure seamless integration and quality assurance
Requirements
- Bachelor's degree in a life science or human subject protection field required; 3-5 years research experience required; at least 2 years regulatory experience preferred
- Experience conducting high-risk biomedical research and/or oncology regulatory research experience preferred
- Effective problem-solving and critical thinking abilities; effective communication and writing skills; strong organizational and time management skills
Preferred Qualifications
- Intermediate/expert level of function in Microsoft Office applications and team interconnectivity tools such as Slack, Microsoft Teams, Zoom, Webex, BlueJeans
- Knowledge and/or experience working with web-based e-regulatory document management systems such as eFlorence, Veeva Systems products
Benefits
- Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits
- Tuition assistance for you, your spouse, and your dependent children
- Generous retirement plans, including a Basic, Matching, and Supplemental retirement plan
- Flexible work hours and options for completing work while promoting balance between work and personal commitments
- Adoption assistance and Penn Home Ownership Services
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