A complete application consists of:
All documents must be in English or include an official English translation.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.
*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of New Drugs/Office of Antimicrobial Products, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
Antibacterial drug resistance is a major threat to public health. In March 2015, The National Action Plan for Combating Antibiotic-resistant Bacteria was developed in response to Executive Order 13676: Combating Antibiotic-Resistant Bacteria (CARB), which was issued on September 18, 2014. The National Action Plan outlines steps for implementing the National Strategy for Combating Antibiotic-Resistant Bacteria to address urgent and serious drug-resistant threats that affect people in the U.S. and around the world. Implementation of the National Action Plan will also support World Health Assembly resolution 67.25 (Antimicrobial Resistance), which urges countries to take urgent action at the national, regional, and local levels to combat resistance.
FDA’s roles in combatting antibacterial drug resistance are to: (1) facilitate the development of new antibacterial drugs to treat patients and (2) advance the science of clinical trial design.
As part of ongoing efforts to harmonize and facilitate the global development of antibacterial drugs, a research project will examine the microbial etiologies of bacterial infections such as hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, community-acquired bacterial pneumonia, complicated urinary tract infections, and complicated intra-abdominal infections in different geographic regions. The epidemiology of resistance phenotypes in different geographic regions will also be evaluated as part of this project.
Under the guidance of a mentor, the selected participant will perform research analysis in conducting comparative epidemiologic analysis of bacterial causes of serious bacterial infections and resistance phenotypes in different geographical regions.
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 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 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 Silver Spring, Maryland, 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:
The qualified candidate should have received a master's or doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date.