The Associate Director for Regulatory Affairs will oversee the portfolio of clinical research undertaken within the department/division, providing direction and strategic planning for clinical research regulatory operations.
Requirements
- Bachelor's degree and 7-10 years relevant experience, or a combination of education and experience required
- Master's degree preferred
- ACRP and/or RAC certification required
- Expert knowledge of GCP, and relevant regulations for the conduct of clinical research including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) and Good Clinical (Research) Practice (GCP) Guidelines required
- Knowledge of appropriate submission mechanisms to different FDA centers (paper, email NextGen Portal, Electronic Submission Gateway (ESG)) required
- Demonstrated project and time management skills are necessary; must be able to work independently with minimal supervision
- Outstanding organizational skills and the ability to function in a team environment are required
- Effective problem solving and critical thinking abilities; effective communication and writing skills; be flexible and able to multi-task
- Prior education or experience with IND/IDE/Expanded Access Applications, drug development process, medical writing, and clinical trial operations required
- Qualified candidates must also demonstrate excellent written and verbal communication skills; advanced computer software skills; a clear attitude of customer service; must be able to work in a fast-paced environment with time sensitive deadlines and competing priorities
Benefits
- Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits
- Flexible Spending Accounts
- Tuition assistance
- Generous retirement plans
- Time Away from Work
- Long-Term Care Insurance
- Wellness and Work-life Resources
- Professional and Personal Development
- University Resources
- Discounts and Special Services
- Flexible Work Hours
- Penn Home Ownership Services
- Adoption Assistance
