Closing Date: July 29, 2022

Overview:

The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE), Division of Generic Animal Drugs (DGAD), is seeking qualified applicants for a Staff Fellow (Health Scientist) position. CVM’s mission is to protect and promote human and animal health. CVM ensures the safety of the American food supply, the safety of animal food and devices, and the safety and effectiveness of animal drugs. Specifically, the Center evaluates new animal drug applications for safety and effectiveness; monitors animal drugs, foods, and devices on the market; evaluates animal food additives for safety and utility; and conducts applied research to further protect human and animal health. As a high-performance organization within the FDA, CVM strives for excellence, innovation, and leadership across all operations, occupations, and grade levels.

The DGAD performs the pre-approval review and processes the approvals of generic new animal drugs across all dosage forms and species as regulated under the Federal Food, Drug and Cosmetic Act (FFDCA), and associated laws and regulations. The Staff Fellow (Health Scientist) will provide support to management by applying knowledge related to general medical and healthcare in support of reviewing applications, utilizing a broad scope of medical expertise to inform scientific and regulatory strategies and related information to make recommendations for Agency action regarding Abbreviated New Animal Drug Applications and Generic Investigational New Animal Drugs.

Duties and Responsibilities:

As a DGAD Staff Fellow (Health Scientist), the incumbent:

Applies understanding of clinical scientific methods and laboratory techniques common to several recognized professional fields in the health, medical or physical sciences (e.g., work in the field of healthcare requiring knowledge of research methodology common to a number of different scientific fields).

Communicates scientific information effectively, both written and orally, with a multi-disciplinary medical team of doctors, nurses, and technicians, members of the scientific community, and expert regulatory professionals. 

Examines human adverse events and animal clinical information while considering additional data obtained by scientific experts to identify potential and existing problems. Provides recommendations regarding their conclusions to senior leaders for possible administrative or physical actions. 

Analyzes and interprets scientific data, regulatory information, facts, and opinions regarding drugs, food, and devices in response to unique problems, questions, or condition collecting evidence necessary to determine violations of the Federal Food Drug and Cosmetic Act enforced by the Agency. 

Performs professional medical research concerned with enforcing the Federal Food Drug and Cosmetic Act and regulations protecting consumers from foods, drugs, and equipment that are impure, ineffective, or improperly labeled or packaged, or in some other way dangerous or not effective. 

Establishes effective program relationships and serves as a resource on scientific and technical program issues to the healthcare community, public and private research organizations, State and local governments, public health agencies, public interest groups and related organizations. 

Determines and recommends decisions to senior leadership that significantly affect the context, interpretation or development of agency policies or programs concerning critical public matters. 

Receives and evaluates information about medical drugs or device products from a variety of sources to determine appropriate courses of actions pertinent to the findings. 

Provides guidance and advice on generic drug development to medical professionals and other regulatory experts. 

Education and Experience:

It is desired that Staff Fellowship candidates should possess at least a Bachelor’s degree from an accredited institution of higher learning. Please see the General Medical and Health Series, 0601 educational requirements.

Desired experience includes:

• Managing competing priorities while working in a fast-paced, team environment.
• Analyzing medical and scientific data. 
• Evaluating multiple medical and biologic factors to assess for potential safety concerns or adverse reactions. 
• Communicating with a multi-disciplinary team consisting of professionals having different proficiencies of scientific knowledge. 
• Using medical terminology to analyze scientific data.
• Working with appropriate guidelines such as protocols and standard operating procedures.

Location and Salary:  

The position is located in Rockville, Maryland and is available immediately. The position will be filled through FDA’s Staff Fellowship Program. Appointments will be made up for up to two years with potential opportunities for renewal. The salary range is $74,950 to $138,868 based on experience and education. 

Application:

Please submit your letter of interest, resume, and unofficial transcripts and/or Foreign Education Evaluation (FEE) for degrees not conferred by an accredited U.S. college or university (Information on FEEs) to: CVMOpportunities@fda.hhs.gov with the subject line of “DGAD Staff Fellow (Health Scientist) Position-Working at CVM” by July 29, 2022.  Questions may also be directed to the CVM Opportunities mailbox. 

**Applications will be reviewed, and interviews will be scheduled on a first come, first served basis.**

Equal Employment Opportunity Policy

The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.

FDA is an equal opportunity employer.