Regulatory Affairs Manager
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.
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.
The Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education. http://www.med.upenn.edu/
Reporting to the Associate Director for Regulatory Affairs (AD-RA) for the Abramson Cancer Center (ACC) Clinical Research Unit (CRU), the Regulatory Affairs Manager will serve as the primary on-site lead for the Regulatory Affairs Coordinators and Office Support Staff in day to day regulatory and compliance issues. The Regulatory Affairs Manager will directly manage, supervise, and train the CRU Regulatory Affairs Office staff; including Regulatory Affairs Coordinators, Regulatory Administrative Specialists, and Research Assistants. The Regulatory Affairs Manager will develop and maintain work instructions to support the daily operations of the Regulatory Office ensuring consistency and accuracy across the team. The Regulatory Affairs Manager will be responsible to delegate staff assignments and track workload intensity and deadlines to ensure timely and appropriate regulatory reporting and compliance for ACC CRU clinical trials, as well as, work in conjunction with the AD-RA to anticipate and plan for changes in operational resource requirements essential for ensuring adherence to local, state and federal regulatory requirements.
The Regulatory Affairs Manager will work collaboratively with internal regulatory groups including the University of Pennsylvania’s Institutional Review Board (IRB), ACC Clinical Trials Scientific Review and Monitoring Committee (CTSRMC), the Data Safety & Monitoring Committee (DSMC), the Department of Operations, Compliance & Monitoring (DOCM), and the Office of Clinical Research (OCR); as well as for external entities including pharmaceutical companies, contract research organizations (CROs), the FDA, and the NCI Cooperative/Clinical Network Groups in the conduct of clinical trials. The candidate must have a thorough knowledge of ICH-GCP regulations and a comprehensive understanding of clinical trial processes and the conduct of clinical research studies.
The Regulatory Affairs Manager will serve as a resource for the ACC CRU Physician-Investigators and clinical research staff on regulatory affairs matters. The Regulatory Affairs Manager will facilitate day to day regulatory submissions to the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events. He/she will facilitate the organization and maintenance of all regulatory affairs documentation/files. He/she will participate in initiation, monitoring, audit and close-out study visits. He/she will participate as needed in study team meetings, disease site group meetings, and ongoing protocol training/compliance meetings.
The minimum of a Bachelor’s degree (in a relevant discipline, biological sciences preferred) and 5-7 years of experience directly related to clinical research regulatory oversight or an equivalent combination of education and experience required. At least 2-3 years of management experience in a hospital academic medical setting or pharmaceutical experience with principle responsibilities related to regulatory affairs operations. Oncology experience preferred. At minimum, 2 years of Good Clinical Practices (GCP) related experience required; thorough knowledge of GCP, and relevant regulations for the conduct of clinical trials including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) and Good Clinical (Research) Practice (GCP) Guidelines. 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. 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; the ideal candidate will have very strong analytical and critical thinking skills, and the ability to build and maintain positive working relationships at all levels of the institution.
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.