Clarification from the agency

All U.S. Citizens

As a Physician, you will perform the following major duties:

• Establish guidelines and performance expectations for staff members;
• Monitor the post market safety and effectiveness of medical devices and/or drug products marked and used nationwide;
• Provide clinical support for the analysis of potential medical device-related public risks;
• Advise on policy guidance, document review and interpretations of legislation affecting medical devices and/or new drugs;
• Establish policies regarding the analysis and interpretation of surveillance or regulation of medical devices, new drugs, generic drugs, etc;
• Serve as the technical expert on medical device and/or drug product issues to the FDA and external organizations within the private and public sectors;
• Determine the safety or efficacy of medical products and or consumer drugs in clinical settings

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. T38 PDP includes additional pay based on the following: Base Market Pay in the amount of $63,600; Clinical Specialty Pay which ranges from $0 to $40,000 and is dependent upon your medical specialty, Hematology/Oncology Clinical Specialty receives an additional $20,303; FDA-related experience pay which ranges from $0 to $10,000 based on years of FDA-related experience or exceptional qualifications pay as determined by the Center; and Board Certification pay of $2,000 for each certification held. To receive T38 PDP, you must have an active unrestricted medical license.

Some positions may be filled as Permanent, Temporary, or Term Appointments.

Conditions of employment

• U.S. Citizenship is required for federal employment.
• Active and Unrestricted Medical License is required and must be submitted with application.
• May be required to serve a one-year probationary period.
• Background investigation is required.
• Submit Unofficial Transcripts with Application.
• E-Verify: If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System.
• Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
• Financial disclosure statement may be required.
• Recruitment and Relocation Bonus: MAY be authorized.
• Research Position: SOME RESEARCH MAY BE REQUIRED.
• May be bargaining unit position.
• All qualification requirements must be met by 11:59 pm (Eastern Time) on Close Date.

Qualifications

In order to qualify for the Physician- GP-0602-14, you must possess ALL of the following:

Basic Qualification Requirement:
Degree: Doctor of Medicine or Doctor of Osteopathy from a school in the United States or Canada approved by a recognized accredited body in the year of the applicant's graduation OR a Doctor of Medicine or equivalent degree from a foreign medical school that provided education and medical knowledge substantially equivalent to accredited schools in the United States. (Such equivalency is demonstrated by permanent certification by the Educational Commission for Foreign Medical Graduates (ECFMG) (or a fifth pathway certificate for Americans who completed premedical education in the United States and graduate education in a foreign country). ( You must submit unofficial copies of transcripts with application package).

- AND -

Licensure: Applicant 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 submit unofficial copies of transcripts with application package).

- AND -

Additional Requirement: 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.

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 of the 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.

Documenting Experience: In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above.

The selected individual is required to obtain and maintain medical staff clinical privileges, including any licensure requirements. If privileges are not obtained or maintained during employment, the employee will be subject to adverse actions, up to and including removal from Federal service. Please also refer to the American Board of Medical Specialist link: http://www.abms.org/.



Positions are located in the Department Health and Human Services (DHHS), Food and Drug Administration (FDA) in Montgomery County, 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.

How you will be evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

Once the job opportunity announcement closes (at 11:59 pm ET on 12/31/2018), a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for Federal employment, and then whether or not you are qualified for this particular position.

These vacancies will be filled through OPM's Direct Hire Authority. Veterans' preference and traditional rating and ranking of applicants do not apply to positions filled under this announcement. Applications received as a result of job fairs, recruitment events, and emergency hiring mechanisms in support of this hiring initiative will also be accepted during the duration of the direct-hire authority.

Research positions require an evaluation of the scientific contributions, recognition and professional standing of the researcher as they related to the position being filled.

A writing sample may be required.

These position may be subject to peer review.

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.

Please follow all instructions carefully. Errors or omissions may affect your eligibility.