<b>Duties</b><br /><br /><b>Summary</b><br /><br /><b>This Direct-Hire</b> <b>position is in the Food and Drug Administration, with multiple locations throughout the U.S. and its territories. </b><br /> See the sections below for more details on the duties & qualifications for this position. Note: Salary figures shown represent the OPM General Schedule Base Salary. Candidates may be eligible to receive Title 38 Physician and Dentist Pay (PDP), in addition to the regular General Schedule base salary. See a additional information under Qualifications. <br /> Learn more about this agency <br /><br /><b>Responsibilities</b><br /><br /><ul> <li>As a Physician , you will perform the following major duties:</li> <li>Monitor the post market safety and effectiveness of medical devices and/or drug products marked and used nationwide;</li> <li>Provide clinical support for the analysis of potential medical device-related public risks;</li> <li>Advise on policy guidance, document review and interpretations of legislation affecting medical devices and/or new drugs/tobacco products;</li> <li>Establish policies regarding the analysis and interpretation of surveillance or regulation of medical devices, new drugs, generic drugs, and/or tobacco products etc;</li> <li>Provide guidance on medical devices, tobacco products and/or safe and effective drug issues;</li> <li>Determine the safety or efficacy of medical products and or consumer drugs in clinical settings;</li> <li>Serve as the technical expert on medical device and/or drug/tobacco product issues to the FDA and external organizations within the private and public sectors.</li> </ul> <br /><br /><b>Travel Required</b><br /><br />Occasional travel – You may be expected to travel for this position.<br /><br />Supervisory status <br /> No <br /><br />Promotion Potential <br /> 15 <br /><br /></li> <b>Requirements</b><br /><br /><b>Conditions of Employment</b><br /><br /><ul> <li>You must be a United States Citizen, National, or other permanent lawful resident owing allegiance to the United States, to be considered.</li> <li>If you were born male, after, December 31st 1959, you must be registered with the Selective Service System, or have an approved exemption. Learn more at www.SSS.gov.</li> <li>Additional selections may be made from this vacancy, within the same geographical area, by other organizational elements from within FDA, through shared corporate recruiting activities.</li> <li>This is a Direct-Hire advertisement: Veterans Preference and Category Rating are NOT applicable! Learn more about Direct-Hire at https: www.opm.gov/policy-data-oversight/hiring-information/competitive-hiring/#url=directhire.</li> <li>See the Additional Conditions of Employment section for more…</li> </ul> <br /><br /><b>Qualifications</b><br /><br /><strong> BASIC QUALIFICATIONS: <br /> In order be eligible for the position of Physician,</strong> (GP-0602-15) <strong>, you must meet the following requirements Basic Qualification, Active Medical License, and Additional Requirements.</strong><br /><br /><strong>Basic Qualification Requirement:</strong><br /> <strong>Degree:</strong> 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). <strong>(You must submit translated unofficial copies of transcripts).</strong><br /><br /><strong>- AND -</strong><br /><br /><strong>Licensure:</strong>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.<br /><br /><strong>- AND -</strong><br /><br /><strong>Additional Requirement:</strong> 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.<br /><br /><strong>Graduate Training:</strong> Subsequent to obtaining a Doctor of Medicine or Doctor of Osteopathic Medicine degree, a candidate must have had at least one (1) year of supervised experience providing direct service in a clinical setting, i.e., a one (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.<br /><br />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).<br /><br />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, (AMA) or Accreditation Council for Graduate Medical Education (ACGME).<br /><br />A fellowship program involves advanced training <strong>(beyond residency training)</strong> 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.<br /><br /><strong>MINIMUM QUALIFICATIONS REQUIREMENTS:</strong> <br /> You must possess one year (52-weeks) of specialized experience, equivalent to at least the next lower grade level<strong> (GP -14)</strong> in the Federal service. Such experience includes <strong>experience planning, coordinating, and evaluating the medical programs and activities of the organization; responsible for policy; writing scientific standards and/or other technical documents relating to medical devices and/or drug/tobacco products; presenting medical/scientific findings at seminars and scientific meetings.</strong><br /><br /><strong>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. </strong><br /> 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. <br /><br /><strong>PHS Commissioned Corps Officers </strong>interested in performing the duties of this position within the Commissioned Corps may apply through this announcement. Candidates will be referred as Commissioned Corps personnel and not as candidates for conversion to a permanent career or career-conditional appointment.<br /><br /><strong> All qualification requirements must be met by 11:59 pm (Eastern Time) on 12/31/2019 . </strong> <strong>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.<br /><br />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:</strong><br /><br /><strong>Center for Biologics & Evaluation Research (CBER)</strong> – 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.<br /><br /><strong>Center for Drug Evaluation & Research (CDER) </strong>- 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.<br /><br /><strong>Center for Devices and Radiological Health (CDRH) </strong>-Applicants should possess excellent communication skills including outreach experience as well as experience with medical device surveillance/identification of problems with medical devices.<br /><br /><strong>Center for Food Safety and Applied Nutrition (CFSAN)</strong> – Seeking applicants with experience in treating allergic reactions or be well-versed in the medical basis for food allergies.<br /><br /><strong>Center for Tobacco Products (CTP)</strong> – Applicants should have direct patient-care related clinical experience. Experience in diagnosis and/or treatment of tobacco-related illness is beneficial and preferred.<br /><br /><strong>The Office of the Commissioner (OC)</strong> – 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.<br /><br />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.<br /><br />Some positions may be filled as Permanent, Temporary, or Term Appointments. <br /><br /><b>Education</b><br /><br /><strong>Foreign Education</strong> <br /> 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.<br /> <strong>For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation .</strong> <br /><br /><strong>Conditions of Employment: </strong> <ul> <li><strong>Security and Background Requirements:</strong> Appointment will be subject to the applicant's successful completion of a background security investigation. Failure to successfully meet these requirements may be grounds for appropriate personnel action. If hired, a background security reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection or appropriate disciplinary action.</li> <li><strong>E-Verify:</strong> 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. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system. The U.S. Department of Health and Human Services is an E-Verify Participant.</li> <li><strong>Direct Deposit:</strong> All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.</li> <li><strong>Pre-employment physical required:</strong> No</li> <li><strong>Drug testing required:</strong> No</li> <li><strong>License required:</strong> Yes, Medical License</li> <li><strong>Mobility agreement required:</strong> No</li> <li><strong>Immunization required:</strong> No</li> <li><strong>Bargaining Unit Position:</strong> TBD</li> <li><strong>Relocation Incentives may be authorized; </strong>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.</li> <li><strong>Financial disclosure statement, OGE-450, required:</strong> Please be advised that this position will 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.</li> <li><strong>Scientific Research Positions:</strong> Research positions require an evaluation of the scientific contributions, recognition and professional standing of the researcher as they related to the position being filled.</li> <li><strong>Writing Samples & Portfolios:</strong> A writing sample or publication portfolio may be required.</li> <li><strong>Peer Review:</strong> Some scientific and research positions may be subject to peer review.</li> <li><strong>This is a Direct-Hire advertisement:</strong> Veterans Preference is not applicable to this advertisement. Learn more about Direct-Hire at https: www.opm.gov/policy-data-oversight/hiring-information/competitive-hiring/#url=directhire … </li> <li><strong>Notice Regarding Corporate Recruiting</strong>: Additional selections may be made from this vacancy, within the same geographical area, by other organizational elements from within FDA, through shared corporate recruiting activities. Your application may be shown to multiple hiring offices.</li> <li><strong>Selecting Service Registration:</strong> If you were born male, after, December 31st 1959, you must be registered with the Selective Service System, or have an approved exemption. Learn more at www.SSS.gov … </li> <li><strong>Current Competitive Service Employees:</strong> This position falls under a government-wide Direct-Hire Authority issued by the Office of Personnel Management (OPM) on October 11th 2018 for certain STEM, medical, and IT Cyber Security positions. Although anyone may apply to this Direct-Hire announcement, per OPM regulations, current employees in the competitive service are not eligible for appointment under Direct-Hire, this includes those on a career or career-conditional appointment. If you meet this restriction and apply, we will notify you that we cannot move your application forward since you cannot be appointed under this authority.</li> </ul> <br /><br /><b>Additional information</b><br /><br /><ul> <li><strong>If you are serving, or have served in the last 5 years (from 12/31/2019) 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.</strong> 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… </li> <li><strong>Direct-Hire Authority</strong>: On October 11th, 2018, the Office of Personnel Management (OPM) issued a special government-wide Direct Hire Authority (DHA) for Scientific, Technical, Engineering, and Mathematics (STEM), and cyber security-related positions nationwide. This position is open to all U.S. Citizens and all qualified candidates will be referred for consideration. The hiring manager may select from any of these qualified candidates without regard to veteran's preference. Learn more about Direct-Hire on OPM's website… </li> <li><strong>Veterans Preference:</strong> Veterans Preference does not apply to this advertisement because it falls under the aforementioned DHA.</li> <li><strong>Reasonable Accommodation: </strong>This agency provides reasonable accommodation to applicants with disabilities. If you need a reasonable accommodation for any part of the application and hiring process, please contact the Bethesda Center Help Desk (888) 478-4340; TTY/TDD: (866) 539-4484; or by email quickquestionsfda.hhs.gov . The decision on granting reasonable accommodation will be made on a case-by-case basis. See the Reasonable Accommodation Policy for more information… </li> <li><strong>Equal Employment Opportunity: </strong>The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor See the EEO Policy for more information… </li> </ul> <br /><br /><b>How You Will Be Evaluated</b><br /><br />You will be evaluated for this job based on how well you meet the qualifications above.<br /><br />Once the job opportunity announcement closes (at 11:59 pm ET on 12/31/2019), your resume and all supporting documents will be reviewed by HR to determine your eligibility for Federal employment and your qualification for this position specifically.<br /><br /><strong>Because this vacancy 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. All qualified candidates will be referred for consideration; the hiring office may conduct interviews at their discretion.</strong><br /><br />Please follow all instructions carefully. Errors or omissions may affect your eligibility. <br /><br /><strong>Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You do not have to respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of the Competencies/KSA's.</strong> <li>Clinical Trials</li> <li>Planning and Evaluating</li> <li>Medical Devices and/or drug/tobacco products</li> <li>Scientific Oral Communication</li> <li>Scientific Written Communication</li> <br /><br /><b>Background checks and security clearance</b><br /><br />Security clearance <br /> Other <br /><br />Drug test required <br /> No <br /><br /></li> <b>Required Documents</b><br /><br /><strong>The following documents are REQUIRED from all applicants for this vacancy, </strong><br /> <strong><ul><li>Licensure, Certification, etc.</li><li>Resume</li><li>Transcript</li></ul></strong><br /> A document that is required must be submitted by all applicants because the document is needed to verify your qualifications, education, or other eligibility information. Failure to provide one of the documents in the list below may result in your application being considered incomplete. <br /><br /><strong>The following additional documents are ACCEPTED for this vacancy, and may be required for some applicants, depending on what eligibility you are claiming.</strong><br /> <ul><li>Cover Letter</li><li>DD-214</li><li>Licensure, Certification, etc.</li><li>VA Letter, etc.</li><li>Resume</li><li>SF-15</li><li>Transcript</li></ul> <br /> These supplemental documents are ued to support your application claims but may not apply to every applicant. If a document appears in this list, it may still be required for verification purposes, such as claims for special hiring authorities, licensure or certification, education, etc. The links below will provide additional information about documentation. <br /><br /><b>Notes about Veterans Preference Documents: </b><br /> Must submit a copy of your DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status. <ul> <b>Active Duty Members: </b> To claim status Under the VOW (Veterans Opportunity to Work) to hire Heroes Act of 2011, submit written documentation from the armed forces that certifies the service member is expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the certification is submitted with your application package. </li> <b>Parents of Deceased or Disabled Veterans:</b> To claim status under Gold Star Fathers Act of 2015, you must submit a copy of the deceased or disabled veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference. Please follow the instructions in the SF-15 on required documentation to be submitted. </li> <b>Widow or Widower</b>: To claim preference, you must submit a copy of the deceased or disabled veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference. Please follow the instructions in the SF-15 on required documentation to be submitted. </li> <b>Spouse of a Living Veteran: </b> To claim preference, you must submit a copy of the veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference, and Documentation of Veteran's Inability to Work Because of a Service-Connected Disability. Please follow the instructions in the SF-15 on required documentation to be submitted. </li> <li>See the Feds Hire Vets site for detailed information about documentation requirements.</li> <li>USAJOBS also maintains a help page for Veterans .</li> </ul> <strong>Learn more about supporting documents and documentation requirements on USAJOBS:</strong> <ul> <li> How to Understand the Required Documents Section </li> <li> What Types of Documents May I Need? </li> <li> How to Manage Your Documents on USAJOBS </li> </ul> <br /><br /><b>If you are relying on your education to meet qualification requirements:</b><br /><br />Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education . <br /><br />Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.