Medical Officer - Direct Hire

Duties

As a Medical Officer, you will be responsible for:

1. Monitoring the post market safety and effectiveness of medical devices and/or drug products marked and used nationwide;
2. Providing clinical support for the analysis of potential medical device-related public risks;
3. Advising on policy guidance, document review and interpretations of legislation affecting medical devices and/or new drugs
4. Establishing policies regarding the analysis and interpretation of surveillance or regulation of medical devices, new drugs, generic drugs, etc.
5. Providing guidance on medical devices and/or safe and effective drug issues;
6. Determining the safety or efficacy of medical products and or consumer drugs in clinical settings;
7. Serving as the technical expert on medical device and/or drug product issues to the FDA and external organizations within the private and public sectors.

Positions are located in the Department of 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)- Regulates 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) Provide regulatory oversight for investigational studies during drug development and making decisions regarding marketing approval for new (innovator 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)- Provides 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 and those available resources are put to the most efficient use.

Qualifications

BASIC REQUIREMENT(S): All Physicians must meet the following basic requirements:

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).

ADDITIONAL REQUIREMENT: In addition to meeting the Basic Requirements above, the candidate must also meet the following:

**RESIDENCY TRAINING:**Five years of residency training in the specialty of the position to be filled or equivalent experience and training.

Note:  A residency program involves training in a specialized field of medicine in an institution accredited for training in the specialty by a recognized body of the American Medical Association (AMA) or AOA.

GRADUATE TRAINING SUBSEQUENT TO DEGREE: 1 year of supervised experience providing direct service in a clinical setting, i.e., 1 year internship or the first year of a residency program. This graduate training must be approved by accrediting bodies recognized within the U.S. or Canada.

**MEDICAL LICENSURE REQUIREMENT:**You must have an active (unexpired) medical license to practice medicine in a State, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States. Medical licensure is required for an individual who will be compensated under the Title 38 Physician and Dentist Pay and for who performs services incident to or directly involving patient care. You  must retain your license while employed with the Department of Health and Human Services (HHS), Food and Drug Administration (FDA). This licensure requirement is in accordance with 38 U.S.C. 7402, OPM Delegation Agreement with HHS, and HHS policy on T38 PDP.

Copy of medical licensure must be submitted with application under this Direct Hire Bulletin.

Note: Within Federal clinical and training programs, a distinction is made between general practice and specialist positions. Specialist positions require graduate training and experience related to the specialty and subspecialty of the position to be filled. Experience may not be substituted for training essential for performing specialized duties. The length and content of residency programs depends upon the specialization and requirements of recognized accrediting American medical specialty boards.

Education

Foreign Education:  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; or full credit has been given for the courses at a U.S. accredited college or university.  For further information, visit: http://www.ed.gov.  This equivalency requirement may be met by permanent certification by the Educational Commission for Foreign Medical Graduates (ECMG), or a fifth pathway certificate for Americans who completed medical education in the United States with graduate education completed in a foreign country.