Associate Director, Regulatory

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University Overview The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Large Employers in 2023. Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play. The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more. Posted Job Title Associate Director, Regulatory Job Profile Title Associate Director, Clinical Research Regulatory Job Description Summary 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. Job Description Job Responsibilities 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. The Associate Director for Regulatory Affairs will directly oversee, train and mentor any reporting Regulatory Affairs Supervisor and/or Regulatory Affairs Specialist A/B/C. In this capacity, the Associate Director for Regulatory Affairs will have oversight of all regulatory staff, including monitoring workload intensity and tracking deadlines to ensure timely and appropriate regulatory reporting and compliance for any/all clinical research conducted within the department/division. The Associate Director for Regulatory Affairs will assist the Director in establishing and maintaining Standard Operating Procedures for the Regulatory Office (or Regulatory Program) to ensure adherence to regulatory requirements of the University of Pennsylvania and all applicable regulatory bodies. In conjunction with any reporting Regulatory Affairs Supervisor, the Associate Director for Regulatory Affairs will evaluate regulatory staff performance and identify areas for improvement. The Associate Director for Regulatory Affairs will serve as the primary point of authority for the Physician-Investigators and clinical research staff on regulatory affairs matters. The Associate Director for Regulatory Affairs will contribute to/assist in the development of training programs for investigators to enhance understand of and compliance with applicable regulations. The Associate Director for Regulatory Affairs will also serve as the key departmental stakeholder representing the department/division when working with internal regulatory groups including the University of Pennsylvania's Institutional Review Board (IRB), the Office of Clinical Research (OCR), and any other ancillary oversight groups; as well as for external entities including pharmaceutical companies, contract research organizations (CROs), the FDA, and research networks such as the National Cancer Institute Cooperative/Clinical Network Groups in the conduct of clinical trials. They will oversee

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