The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Office of Blood Research and Review (OBRR), Division of Blood Components and Devices (DBCD) is recruiting to fill a Physician position. In DBCD, the duties of a Physician include, but are not limited to, performing scientific reviews of applications related to blood products for transfusion, devices for collection and processing of blood components, plasma volume expanders (e.g., albumin, dextrans, and hetastarches), hemoglobins including synthetic versions and derivatives, and pathogen reduction methodologies for blood components intended for transfusion. In addition, Physicians in DBCD are responsible for the review of clinical trial protocols and facilitation of clinical development of novel biologic products. DBCD is located at the FDA’s White Oak campus in Silver Spring, Maryland.
Qualified candidates must have an M.D. or D.O. degree, be board certified or eligible and be currently licensed or able to obtain licenses in the District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States. Candidates must have at least 1 year of supervised experience providing direct service in a clinical setting (internship) and 4 years of graduate training (residency/fellowship) in the specialty of the position to be filled or equivalent experience and training. The desired specialty area is Transfusion Medicine.
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.
The position of Physician falls under the 0602 occupational series. To qualify for this position at grade GP-14, you must meet Time-in-Grade requirements by 11:59 pm EST on 10/31/2023.
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.
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.
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 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.
Additional requirements for GP-14: 4 years of graduate training in the specialty of the position to be filled or equivalent experience and training. Examples of equivalent experience include having knowledge of laws, regulations, and standards that govern medical practices/procedures; and/or in the evaluation, diagnosis and treatment of a wide variety of diseases and medical conditions.
Please be sure to clearly define the number of years when documenting training and/or experience, using month and year (from MM/YY to MM/YY) in addition to describing duties performed during that time period.
All qualification requirements must be met by 11:59 pm (Eastern Time) on 10/31/2023. 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. You must continue to meet all requirements through the hiring process.
You may be asked to provide additional information at a later time. All interview requests and selection decisions are at the full discretion of the hiring office.
NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date . To verify your application is complete, log into your USAJOBS account, https://my.usajobs.gov/Account/Login, select the Application Status link and then select the More Information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process.
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.
Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.
Applicants must submit a copy of your Doctor of Medicine transcripts (unofficial) or degree, foreign equivalency, or ECFMG results with your application to demonstrate you possess the required education to meet the Basic Qualifications. Failure to do so will result in you being rated ineligible for this position. Your transcripts must show completion/conferred dates. Unofficial transcripts and copies of your Doctor of Medicine degree will be accepted in the application package. However if selected, official transcripts will be required and must be received prior to onboarding with the FDA.
TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. 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, see the Foreign Education section below for additional requirements.
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 receive consideration and credit for the information we can access.
FOREIGN EDUCATION Applicants using part, or all of their education completed outside of the U.S. to meet the qualification requirements, must have their foreign education evaluated by an accredited organization to ensure that the foreign education is comparable to education received in accredited educational institutions in the U.S. We will only accept the completed foreign credential evaluation.
To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery. Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded. Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below:
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 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.
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: YES, NTEU
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.
This position may require financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For more information please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.
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 positionsacross 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 10/31/2023) 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.
All requirements must be met by the closing date of this announcement (10/31/2023); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.
Center for Biologics Evaluation and Research (CBER)
Office of Management (OM)
Division of Human Capital (DHC)
U.S. Food and Drug Administration
AABB (Association for the Advancement of Blood & Biotherapies) is an international, not-for-profit organization representing individuals and institutions involved in the fields of transfusion medicine and biotherapies. The Association works collaboratively
to advance the field through the development and delivery of standards, accreditation and education programs. AABB is dedicated to its mission of improving lives by making transfusion medicine and biotherapies safe, available and effective worldwide.