*Applications will be reviewed on a rolling-basis.
CDER Office/Lab and Location: A research opportunity is available with the Office of Medication Error Prevention and Risk Management (OMEPRM), Office of Surveillance and Epidemiology (OSE) within the Food and Drug Administration (FDA) located in Plymouth Meeting, Pennsylvania. The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.
Research Project: Formal training will be held at the Institute for Safe Medication Practices (ISMP). The participant will gain knowledge in root cause analysis (RCA), Failure Mode and Effects Analysis (FMEA), and other risk-assessment tools and methods. Through this research project, the participant will gain knowledge of advanced regulatory science in assessing user interface differences between biosimilar/biosimilar interchangeable products and reference products.
Under the guidance of the mentor, together with the ISMP, the participant will receive formal training in RCA, FMEA, post-market surveillance, and other risk-assessment tools and methods. The participant will gain hands-on experience in the evaluation and analysis of medication errors reported to the FDA Adverse Event Reporting System and ISMP Medication Reporting Program. The mentor will guide the participant in developing the specific research methodology, analyzing the research findings, and applying the findings to regulatory review.
This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The appointment is for 12 months. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at FDA in the Plymouth Meeting, Pennsylvania area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.
FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency. This agreement covers such topics as the following:
– Non-employee nature of the ORISE appointment;
– Prohibition on ORISE Fellows performing inherently governmental functions;
– Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
– The fact that research materials and laboratory notebooks are the property of the FDA;
– ORISE fellow’s obligation to protect and not to further disclose or use non-public information.
The qualified candidate should have received a doctoral degree in one of the relevant fields. Degree must have been received within the past five years.
– A strong background in medication error prevention and analysis.
– A year of pharmacy residency practice in an educational and training environment is desired