Research Project Description
Regulatory Science Course Development Fellowship
Office of Translational Sciences
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Silver Spring, MD
A fellowship opportunity is available in the Office of Translational Science (OTS) within the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA). OTS promotes and protects the public health by assuring that safe and effective drugs are available to Americans.
OTS is developing content for a course in regulatory science focused on the process of evaluating evidence of the efficacy and safety of pharmaceutical products throughout their life cycle. The course content will be based, in part, upon publically available guidances, reviews, advisory committee meetings, briefing materials, talks and presentations, and case studies that are accessible from FDA’s website. Under the guidance of a senior CDER scientist, activities may include:
- Identifying and coordinating materials for case studies
- Evaluating best examples to illustrate regulatory decision making
- Interviewing CDER reviewers who have direct knowledge of the cases
The selected participant will have the opportunity to develop and expand his/her skills that contribute to identifying, extracting, compiling and coordinating case studies that illustrate multiple topic areas in regulatory decision making. S/he will interact with a variety of scientists in CDER and FDA that may contribute to the course content.
The Research Participation Program for FDA is administered by the Oak Ridge Institute for Science and Education (ORISE). The initial appointment is for one year, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend depending on educational level and experience. The participant must show proof of health insurance. The appointment is full-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA or the program administrator, and there are no fringe benefits paid.
- A Doctoral degree in a scientific discipline with experience in research or course preparation received within the last five years. Preference will be given to candidates with Statistics or clinical sciences background.
- Ability to perform data management activities on large databases.
- Strong IT background.
- Knowledge of the regulatory process, clinical science or clinical trials and evaluation of evidence from them including safety assessment is helpful.
How to Apply:
To be considered, please send a current CV/resume to the attention of FDArpp@orau.org. Please reference FDA-CDER-2014-0001 in all communications.