Postdoctoral Fellowship in Regulatory and Medical Affairs
University of Maryland School of Pharmacy
October 1, 2018
Fellowship - Experienced
This position is funded by the Clinical Use of Bulk Drug Substances Nominated for Use in Compounding by Outsourcing Facilities grant sponsored by the FDA. The program duration is three years and is designed to develop researchers focused in regulatory and medical affairs.
This Postdoctoral Fellow will be responsible for aiding in research regarding the use of bulk drug substances in pharmaceutical compounding nominated for inclusion on the List of Bulk Drug Substances Approved for use in Compounding by 503b Facilities. This includes conducting literature reviews, hosting focus groups and interviews, survey development, distribution, and analysis, performing outreach to medical specialists and outsourcing facilities as needed, and preparation of materials for submission to the Food and Drug Administration (FDA). This position will require collaboration with researchers at the University of Maryland, the FDA, local and national medical specialists and practitioners, leadership of various national specialty organizations, as well as outsourcing facilities.
Doctoral degree (MD, PharmD, PhD) in a health-related discipline or focus.
About University of Maryland School of Pharmacy
The University of Maryland is one of four schools awarded The Center of Excellence in Regulatory Science and Innovation (M-CERSI) funded by the U.S. Food and Drug Administration. The center focuses on modernizing and improving the ways drugs and medical devices are reviewed and evaluated. This center is a collaborative partnership between the University of Maryland, College Park, and the University of Maryland, Baltimore. Researchers from both campuses work with FDA staff to support the development of new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.
The University of Maryland School of Pharmacy, through its education, research, and service programs, strives to improve the health and well-being of society by aiding in the discovery, development, and use of medicines.