Connect with ORISE...on the GO! Download the new ORISE GO mobile app in the Apple App Store or Google Play Store to help you stay engaged, connected, and informed during your ORISE experience and beyond!
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.
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 U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This research covers more than just medicines. The project in the Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), will use model-informed drug development approaches, such as population pharmacokinetic modeling, pharmacokinetic-pharmacodynamic modeling, and clinical trial simulations for regulatory research. Example areas of research include using model-based approaches for characterizing and quantifying effects of immunogenicity on drug exposures and evaluating sensitivity to identify relevant product pharmacokinetic differences across different routes of administration.
Under the guidance of the mentor, the participant will learn model-based approaches, such as pharmacokinetic, pharmacodynamic, and statistical models, and combine them into a prediction framework to evaluate drug efficacy/safety.
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 or be currently pursuing a master's or doctoral degree in one of the relevant fields with completion by June 30, 2023. Degree must have been received within the past five years.
Preferred skills:
I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.)
ORISE GO
The ORISE GO mobile app helps you stay engaged, connected and informed during your ORISE experience – from application, to offer, through your appointment and even as an ORISE alum!
You gave a rating of 0 star(s)
SECURITY/PRIVACY NOTICE
By continuing to use this system you indicate your awareness of and consent to the following terms and conditions of use. LOGOUT IMMEDIATELY if you do not agree to the conditions stated in this warning.
SECURITY NOTICE
This system is part of a Federal information system. This system is monitored for security purposes to ensure it remains available to all users and to protect information in the system. The system employs software programs to monitor network traffic to identify unauthorized activities. By accessing this system, you are expressly consenting to these monitoring activities. Unauthorized attempts to defeat or circumvent security features; to use the system for other than intended purposes; to deny service to authorized users; to access, obtain, alter, damage, or destroy information; to upload or change information; to otherwise cause system or information damage; or otherwise to interfere with the system or its operation, is prohibited. Evidence of such acts may be dis-closed to law enforcement authorities and result in prosecution under the Computer Fraud and Abuse Act of 1986 and the National Information Infrastructure Protection Act of 1996, or other applicable laws.
PRIVACY NOTICE
This system is for authorized use only. Use of this system constitutes consent to security monitoring and testing. All activity is logged with your host name and IP address. Users (authorized or unauthorized) have no explicit or implicit expectation of privacy. Any or all uses of this system and all files on this system may be intercepted, monitored, recorded, copied, audited, inspected, and dis-closed to authorized site and law enforcement personnel, as well as authorized officials of other agencies, both domestic and foreign. By using this system, the user consents to such interception, monitoring, recording, copying, auditing, inspection, and disclosure at the discretion of authorized site or law enforcement personnel. Unauthorized or improper use of this system may result in administrative disciplinary action and civil and criminal penalties.
You have been inactive on this page for . You will be logged out after 03:00:00.
Select an icon below to visit the website and download an appropriate browser.
For help, please email Zintellect@orau.org.
Question: What is the deadline for submitting an application?
Answer: Not all opportunities have application deadlines. Some opportunities remain open until they are filled. If an opportunity has an application deadline, then it will be listed in the opportunity details or in the opportunity catalog.
Question: How do I reset my password?
Answer: If you have forgotten your password or wish to reset your password, use the "Forgot password or username?" tab on the login to reset it.
Question: I forgot my username. How do I retrieve it?
Answer: Use the "Forgot password or username?" tab on the login. You will receive an email containing your username.
Question: What do I need to submit an application?
Answer: Typically, applicants are required to submit a resume or CV, an official copy of their transcripts or academic record, and a minimum of two references at the time they apply. Additional requirements such as a writing sample, thesis or dissertation, etc. may be required. Review the opportunity details for additional information about the requirements for applying for an opportunity.
Question: Where do I upload my transcripts?
Answer: If required, you will be asked to upload your transcript as a part of the application process.
Question: Where do I submit a writing sample?
Answer: If required, you will be asked to upload a writing sample as part of the application process.
Question: Can a family member serve as a reference?
Answer: No; family members may not serve as references. References must be able to speak to your educational and/or professional experience. At least one academic reference is preferred.
Our Zintellect A.I. is constantly learning how to Match you to our opportunities! So, we want to know when we get it right or when we get it wrong. This will help us make our better! Plus, as a potential applicant to one of our many opportunities across the country, we value you and want to help you on your career path!
