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 (Consumer Safety Officer) 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 work of the Staff Fellow (Consumer Safety Officer) involves applying animal or medical knowledge related to consumer safety in support of reviewing applications, utilizing a broad scope of animal and medical expertise to inform scientific and regulatory strategies and related information to make recommendations for Agency action regarding Abbreviated New Animal Drug Applications ONADE and Generic Investigational New Animal Drugs. 

Duties and Responsibilities:

As a DGAD Staff Fellow (Consumer Safety Officer), the incumbent:

Maintains and applies scientific knowledge of consumer safety and related medical and bioequivalence science. Gains an understanding of consumer related issues associated with products under review. May apply regulations, laws, and precedents to pre-approval work.

Researches and locates appropriate sources of data and scientific information; obtains and documents this information for electronic storage in support of approval process and research activities and goals. 

Analyzes and interprets scientific data, regulatory information, facts and opinions regarding animal drugs, food, and devices in response to unique problems, questions, or conditions. 

Evaluates data and information from a variety of sources to determine the safety and effectiveness of new or marketed animal drugs, foods, and devices as well as suggests appropriate courses of action pertinent to investigative and/or review findings. 

Evaluates scientific documents and data (e.g., industry submissions) to ensure quality and completeness of information and/or to identify gaps that would warrant requests for additional data. 

Applies scientific knowledge and professional clinical medical experience to develop and manage an active review process and other tasks related to the protection of animal and public health. 

Provides recommendations to senior management officials on administrative/regulatory actions (e.g., deficiency letters, information request letters or approvability).

Integrates and synthesizes information from a variety of sources (e.g., databases, policies, regulations) to provide scientific recommendations, including approval pathways for generic new animal drugs, foods, and devices. 

Advises senior management officials on consumer safety issues related to drugs, food, and devices to include associated laws, regulations, and policies. 

Education and Experience:

It is desired that Staff Fellowship candidates should possess at least a Bachelor’s level degree from an accredited institution of higher learning. Please see the Consumer Safety Series, 0696 educational requirements.

Desired experience includes:

• 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. 
• Working with appropriate guidelines such as protocols and standard operating procedures.
• Managing competing priorities while working in a fast-paced, team environment.

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 (Consumer Safety Officer) 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.