*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Translational Sciences/ Office of Administrative Operations (OAO), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland. 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.
The Office of Administrative Operations is an office within the Office of Translational Sciences (OTS) that provides professional administrative management services to all organizational units. The COVID-19 pandemic has lead to the emergence of new conceptualizations for scientific collaboration and interactions. New technologies and the shift to an all-virtual environment has presented specific technology and space planning related challenges. This project will explore conceptualization of appropriate use of space and resources in replacement of manual planning for these efforts.
Under the guidance of a mentor, the selected participant will explore emerging technologies to develop and apply spatial planning and design skills to streamline and maximize efficiency of planning for revised and rapidly changing space utilization plans in fulfillment of the public health mission.
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 six months, 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:
- 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.