Food and Drug Administration/Center for Veterinary Medicine
August 13, 2018
Full Time - Experienced
The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE), Division of Generic Animal Drugs is seeking qualified applicants for the position of Interdisciplinary Scientist. The Division of Generic Animal Drugs is the target animal review division who reviews submissions and applications for generic versions of previously approved new animal drugs (often called pioneer or reference listed new animal drugs). These generic applications and submissions we receive encompass all the animal species and classes that for pioneer new animal drugs are divided amongst the other three target animal divisions in ONADE. We also review suitability petitions. Suitability petitions are requests for permission to seek approval for a generic product that differs from the reference listed new animal drug in specific ways (i.e., route of administration, dosage form, strength (concentration), one of the active ingredients in a reference listed combination new animal drug, or one of the Type A medicated articles in a reference listed feed use combination new animal drug). Through our independent and collaborative reviews and evaluations, we support the Center’s scientific and regulatory goals. This position will be filled through FDA’s Staff Fellowship program. The appointment is for up to two years with opportunities for renewal.
As an Interdisciplinary Scientist in the Office of New Animal Drug Evaluation, Division of Generic Drugs you will contribute to the mission of performing regulatory reviews of New Animal Drug Applications and Investigational New Animal Drug files submitted by sponsors or other parties (e.g., public, regulated industry, other government agencies, foreign entities). You will conduct data quality assessment on the data submitted, manage the review process and prepare written documentation of review, policy and procedures and standard operating procedures. Applicants should have experience working in a regulatory, biological science, chemistry, animal science, or veterinary medical setting. It is preferable that applicants have a general understanding of information relevant to one or more of the following disciplines: laboratory animal medicine, food animal production, clinical veterinary practice, analytical chemistry, or pharmacology. A relevant scientific education will be considered in lieu of work experience. Experience working with Microsoft office products, conducting meetings, and communicating scientific information to varied audiences is necessary. Experience with technical writing and an understanding of pharmaceuticals is highly desired.
ONADE offers many benefits and operates in a hoteling work environment. Hoteling is an arrangement where employees reserve non-dedicated, non-permanent workspace at the Rockville duty station on an as-needed basis and as required (when in person attendance is deemed important and regardless of need, no less than 2 days per pay period). Applicants should be located in, or willing to relocate to, the greater Washington DC area. ONADE provides the basic technology (e.g., laptop, monitors, webcam) needed to effectively work in the Rockville office and in a teleworking location. Hoteling, along with a strong telework program and strong electronic communication and workflow tools, affords employees in ONADE the flexibility to balance work/life demands while contributing to our high performing organization.
The position is located in Rockville, Maryland and is available immediately. The position can be filled at the GS-9 or GS-11 equivalent level based on experience and education. The salary range for the GS-9 equivalent level is $56,233 to $73,105 and for the GS-11 equivalent level is $68,036 to $88,450.
The vacancy announcement will close on October 12, 2018. **Applications will be reviewed and interviews will be scheduled on a first come, first serve basis.**
Please submit your letter of interest, resume, and transcripts to: CVMOpportunities@fda.hhs.gov with the subject line of “Generics-Interdisciplinary Scientist”. Questions may also be directed to the CVM Opportunities mailbox. FDA is an equal opportunity employer and is a smoke-free environment.
About Food and Drug Administration/Center for Veterinary Medicine
Join the Center for Veterinary Medicine (CVM) in the protection of human and animal health. As part of the U.S. Food and Drug Administration, CVM has regulatory authority over food, food additives, drugs, and devices for animals. These animals include those from which human foods are derived, as well as pet (or companion) animals. We are responsible for regulating the food, food additives, drugs, and devices given to over one hundred million companion animals, plus millions of poultry, cattle, swine, and minor animal species. As a high performance organization, we strive for excellence, innovation, and leadership across all operations and occupations. Learn more about why CVM is the best fit for your talents and keep in touch with us about future job and/or internship opportunities. Begin your career with CVM today. Start by visiting here: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/ucm554240.htm.