With the oversight of the Director, the Associate Director for Regulatory Affairs will oversee the portfolio of clinical research undertaken within the department/division. The Associate Director for Regulatory Affairs assists the Director in providing direction and strategic planning for clinical research regulatory operations including overseeing the activities of a Regulatory Office (or Regulatory Program)/reporting regulatory affairs staff, anticipating and planning for changes in the regulations governing clinical research, planning for the regulatory aspects of growth of department/division research activity, and liaising with regulatory groups across the department/division, University, and federal government.
Requirements
- Bachelor’s degree and 7-10 years relevant experience, or a combination of education and experience required
- 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
Benefits
- Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family’s health and welfare
- Tuition: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions
- Retirement: Penn offers generous retirement plans to help you save for your future
- Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year
- Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility
- Wellness and Work-life Resources: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life
- Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally
- Discounts and Special Services: From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff
- Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments
- Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements
- Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household
