Duties

• Physicians will support the administration of health programs through a variety of activities. May develop clinical rationale for the coverage of new medical services, devices, and/or diagnostic methods.
• Monitor the post market safety and effectiveness of medical devices and/or drug/tobacco products, food safety and veterinarian medicine marked and used nationwide.
• Support the administration of occupational health programs and safety and health initiatives, provide associated consultation services. Determine the safety or efficacy of medical products and/or consumer drugs in clinical settings.
• Serve as a technical resident expert on various medical issues and products to include new drugs and tobacco products as well as medical devices, food safety and/or veterinarian medicine.
• May conduct clinical reviews and analyses of the quality of Federal health programs. Provide clinical support for the analysis of potential medical device-related public risks.
• Conduct medical review and evaluation of safety and health regulations, provide medical, toxicological, and epidemiological assistance to support safety and health investigations, etc.
• Design, conduct, and analyze evaluation studies and surveillance projects to measure the effectiveness of scientific public health programs and strategies.
• Establish policies regarding the analysis and interpretation of surveillance or regulation of medical devices, new drugs, generic drugs, and/or tobacco products, etc. and guidelines and performance expectations for staff members.
• Advise on policy guidance, conduct document reviews and interpret legislation affecting medical devices and/or new drugs or tobacco products.

Requirements

Conditions of Employment

• Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.
• Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
• Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
• Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
• THIS POSITION IS SUBJECT TO THE COVID-19 VACCINE MANDATE AS A CONDITION OF EMPLOYMENT.

Qualifications

The position of Physician falls under the 0602 occupational series. To qualify for this position at grade GP- 14, you must meet the following:

Basic Requirements

A. DEGREE : You must have a Doctor of Medicine, Doctor of Osteopathic Medicine or equivalent from a school in the United States or Canada. This degree must have been accredited by the Council on Medical Education of the American Medical Association (external link) ; Association of American Medical Colleges (external link) ; Liaison Committee on Medical Education (external link) ; Commission on Osteopathic College Accreditation of the American Osteopathic Association (external link) , or an accrediting body recognized by the U.S. Department of Education (external link) at the time the degree was obtained.

OR

B. Degree from Foreign Medical School: A Doctor of Medicine or equivalent degree from a foreign medical school must provide education and medical knowledge equivalent to accredited schools in the United States. Evidence of equivalency to accredited schools in the United States is demonstrated by permanent certification by the Educational Commission for Foreign Medical Graduates (external link) , a fifth pathway certificate for Americans who completed premedical education in the United States and graduate education in a foreign country, or successful completion of the U.S. Medical Licensing Examination.

NOTE: You must provide a copy of your Doctor of Medicine transcripts (unofficial), foreign equivalency, or ECFMG results with your application to document that you have met the education requirement. Failure to do so will result in you being rated ineligible for this position. Your transcripts must show completion/conferred date. Unofficial transcripts will be accepted in the application package. Official transcripts will be required prior to your starting work.

AND

LICENSURE: For all grade levels and positions, applicants must possess a current, active, full, and unrestricted license or registration as a Physician from a State, the District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States. You must provide a copy of your medical license with your application. Failure to do so will result in you being rated ineligible for this position.

Note: Due to COVID-19, a State Emergency Declaration was provided for medical license holders in specific states, that approved extensions to license expiration dates. If your medical license expired during the COVID-19 health emergency, and you were provided an extension for the state where your medical license was obtained, please provide the appropriate documentation along with your expired medical license to meet the licensure requirement.

AND

GRADUATE TRAINING: Subsequent to obtaining a Doctor of Medicine or Doctor of Osteopathic Medicine degree, a candidate must have had at least 1 year of supervised experience providing direct service in a clinical setting, i.e., a 1-year internship or the first year of a residency program in a hospital or an institution accredited for such training. For purposes of this standard, graduate training programs include only those internship, residency, and fellowship programs that are approved by accrediting bodies recognized within the United States or Canada. Descriptions of such programs are described below.

An internship program involves broadly based clinical practice in which physicians acquire experience in treating a variety of medical problems under supervision (e.g., internal medicine, surgery, general practice, obstetrics-gynecology, and pediatrics). Such programs are in hospitals or other institutions accredited for internship training by a recognized body of the Accreditation Council for Graduate Medical Education (ACGME) (external link) .

A residency program involves training in a specialized field of medicine in a hospital or an institution accredited for training in the specialty by a recognized body American Medical Association (external link) , (AMA) or Accreditation Council for Graduate Medical Education (ACGME) (external link) .

A fellowship program involves advanced training (beyond residency training) in a given medical specialty in either a clinical or research setting in a hospital or an institution accredited in the United States for such training.

AND

ADDITIONAL TRAINING/QUALIFICATIONS:
Additional requirements for GS-14 -- 4 years of graduate training in the specialty of the position to be filled or equivalent experience and training in regulatory science and/or medical research.

Please be sure to clearly define the number of years using month and year in additional to describing duties performed during that time period.

IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume.

All qualification requirements must be met by 11:59 pm (Eastern Time) on 12/30/2021 If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible or your score may be adjusted to more accurately reflect your skills and abilities.

Positions are located in the Department Health and Human Services (DHHS), Food and Drug Administration (FDA) in Prince George's and Montgomery Counties, MD and may be filled in the following Centers:

Center for Biologics & Evaluation Research (CBER) - Applicant will regulate biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act.

Center for Drug Evaluation & Research (CDER) - Applicant will provide regulatory oversight for investigation studies during drug development and making decisions regarding marketing approval for new (innovative or non-generic) drugs, including decisions related to changes to already marketed products.

Center for Devices and Radiological Health (CDRH) -Applicants should possess excellent communication skills including outreach experience as well as experience with medical device surveillance/identification of problems with medical devices.

Center for Food Safety and Applied Nutrition (CFSAN) - Seeking applicants with experience in treating allergic reactions or be well-versed in the medical basis for food allergies.

Center for Tobacco Products (CTP) - Applicants should have direct patient-care related clinical experience. Experience in diagnosis and/or treatment of tobacco-related illness is beneficial and preferred.

The Office of the Commissioner (OC) - Applicant will provide centralized agency-wide program direction in management services for agency programs to ensure that FDA's consumer protection efforts are effectively managed within its regulatory framework.

Candidates may be eligible to receive Title 38 Physician and Dentist Pay (PDP), in addition to the regular General Schedule base salary. T38 PDP is determined by the FDA Center to which you may become employed. To receive T38 PDP you must have an active unrestricted medical license.

Positions will be filled as Permanent with a full-time or part-time work schedule.

Education

Foreign Education
If you are claiming education as any part of your qualifications for this position, you must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program. For further information, click on foreign education .

Submitting Your Transcripts: Positions which are scientific or technical in nature often have very specific educational requirements. A transcript is required to verify educational achievement. Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.

Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may only receive consideration and credit for the information we can access.

Important Information:

Vaccination Mandate :
* In accordance with Executive Order 14043 , Federal employees are required to be fully vaccinated against COVID-19 regardless of the employee's duty location or work arrangement (e.g., telework, remote work, etc.), subject to exceptions that may be required by law. If selected, you will be required to submit proof of vaccination by November 22, 2021 or before your entrance on duty if you are selected after the compliance date. Your HR Consultant will provide a list of documents acceptable as proof of vaccination and instructions for how to submit a request for a legally required exception, if needed, to comply with vaccination requirement.

Expanded/Maximum telework Posture :
* Due to COVID-19, the agency is currently in a maximum telework posture. If selected, you may be expected to telework upon your appointment. As employees are permitted to return to the office, you may be required to report to the duty station listed on this announcement within 30 calendar days of receiving notice to do so, even if your home/temporary telework site is located outside the local commuting area. Your position may be eligible for workplace flexibilities which may include remote work or telework options, and/or flexible work scheduling. These flexibilities may be requested in accordance with the HHS Workplace Flexibilities policy.

See the Application Manager Documentation for tips on submitting your paper-based documents.

Additional information

Additional Conditions of Employment:

• Pre-employment physical required: NO
• Drug testing required: NO
• License required: YES, MEDICAL LICENSE
• Mobility agreement required: NO
• Immunization required: NO
• Bargaining Unit Position: YES, 3591
Telework eligible position: Telework is at the discretion of the supervisor.
• Financial disclosure statement, OGE-450, required: Please be advised that this position may be subject to FDA's prohibited financial interest regulation and may require the incumbent of this position to divest of certain financial interests. Applicants are advised to seek additional information on this requirement from the hiring official before accepting this position.
• Ethics pre-clearance required: This position is subject to strict prohibited financial interest regulations which could restrict the type of financial interest (stock holdings) for the employee, the spouse, and minor children of the employee. Selectee for this position will be required to file a Confidential Financial Disclosure Report (OGE 450) and may require the selectee to obtain clearance from the FDA Division of Ethics and Integrity before a final offer can be made. For additional information on the prohibited financial interests, please visit the FDA Ethics and Integrity Office website at http://www.fda.gov/AboutFDA/WorkingatFDA/Ethics/default.htm .

Additional Information:

• Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.
• Additional selections may be made for similar positions across the Department of Health and Human Services (HHS) within the local commuting area(s) of the location identified in this announcement. By applying, you agree to have your application shared with interested selecting official(s) at HHS. Clearance of CTAP/ICTAP will be applied for similar positions across HHS.
• If you are serving, or have served in the last 5 years (from 12/30/2021) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. See Political Appointee FAQ - OPM for more.