NYU School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health, the School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. For more information, go to med.nyu.edu, and interact with us on Facebook, Twitter and Instagram.
Position Summary: We have an exciting opportunity to join our team as a Manager-Research Regulatory.
Reporting to the Director of Research Regulatory Services in the Office of Science and Research (OSR), the Manager will provide regulatory support services to research faculty in the planning and conduct of clinical trials, including development of Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications and in interactions with the FDA supporting the filing and ongoing management of these applications.
Support the development and coordination for the submission of Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications
Facilitate communication with the relevant regulatory agencies as appropriate; and if requested facilitating FDA interface for investigators
Assist investigators and research teams with determinations of applicability of IND and IDE requirements, including conducting the necessary regulatory and scientific literature searches
Collaborate with Sponsor-Investigators and their research teams to maintain and manage their IND/IDEs
Provide guidance to investigators on the use of institutional templates for drug and device protocols and IND/IDE applications
Support the implementation and maintenance of the institutional IND/IDE Sponsor/Sponsor-Investigator standard operating procedures (SOPs)
Serve as an educator and lead individualized/group training sessions to ensure regulatory compliance with regulatory requirements, federal guidance, and institutional policies and SOPs
Consult on the effort and budget required for regulatory activities in the submission of funding proposals
Maintain up-to-date knowledge on FDA and international regulatory requirements and current practice standards for clinical trials including regulatory submissions
Train and mentor other regulatory staff members
Contribute significantly to the development, implementation and ongoing evaluation of strategies and processes to improve and ensure that FDA-regulated research at the institution is conducted in accordance with all required regulations
Oversee centralized clinicaltrials.gov registration and reporting process and staff
To qualify you must have a Advanced degree in a health-related field (clinical research is preferred)
5 years of regulatory or relevant drug/device industry experience required
Strong working knowledge of FDA regulations and Good Clinical Practices (GCP), and experience in the interpretation of regulations and guidelines
Prior involvement in the guidance and preparation of major regulatory submissions
Ability to work both independently with minimal direction and within project teams, committees, etc. to attain goals
Professional experience in FDA IND/IDE/regulatory role
Regulatory Affairs Certification (RAC) by the Regulatory Affairs Professional Society (RAPS)
Qualified candidates must be able to effectively communicate with all levels of the organization.
NYU School of Medicine provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where you'll feel good about devoting your time and your talents.
NYU School of Medicine is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sex, sexual orientation, transgender status, gender dysphoria, national origin, age, religion, disability, military or veteran status, marital or parental status, citizenship status, genetic information or any other factor which cannot lawfully be used as a basis for an employment decision. We require applications to be completed online.
NYU Langone Medical Center, a world-class patient-centered integrated academic medical center, is one of the nation's premier centers for excellence in clinical care, biomedical research, and medical education. Located in the heart of Manhattan, NYU Langone is composed of four hospitals – Tisch Hospital, its flagship acute care facility; Rusk Rehabilitation; the Hospital for Joint Diseases, one of... only five hospitals in the nation dedicated to orthopaedics and rheumatology; and Hassenfeld Children's Hospital, a comprehensive pediatric hospital supporting a full array of children's health services across the medical center – plus the NYU School of Medicine, which since 1841 has trained thousands of physicians and scientists who have helped to shape the course of medical history. The medical center's tri-fold mission to serve, teach, and discover is achieved 365 days a year through the seamless integration of a culture devoted to excellence in patient care, education and research. For more information, go to www.NYULMC.org.