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Summary This Direct-Hire position is in the Food and Drug Administration and is located in the Center for Tobacco Products (CTP) located in Silver Spring, Maryland, White Oak Campus. Responsibilities Assists with portions of broader projects involving reviews, analyses, and administration for premarket review of tobacco product applications and other regulatory submissions. Aids with non-complex tobacco product submissions from initial submission to final regulatory action and provides input to higher grade scientists for their use in health science projects Ensures all administrative files and database records for tobacco applications and projects are accurate and maintained in a complete, accurate, and up-to-date manner consistent with Center’s records management policies. Reviews laws, regulations, guidance, precedents, and procedures associated with assigned technical area. Drafts and submits correspondence to higher-level scientist for their review to ensure it is logical, clear, and prepared in a professional manner. Requirements Conditions of Employment Qualifications The position of Regulatory Health Program Coordinator falls under the 0601 occupational series. To qualify for this position at grade GS-7/9, you must meet all requirements by 11:59 pm EST on 06/12/2025. Basic Requirements Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications. AND Minimum Qualifications: Specialized experience is experience that equipped the applicant with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled. The specialized experience must demonstrate one year of full-time work experience , or the equivalent if part-time (for example, an employee working 20 hours per week for a 12-month period should be credited with 6 months of experience.) Experience may have been obtained in either the federal service or its equivalent with state or local government, the private sector, or nongovernmental organizations. GS-7: Additional Requirements: Applicants must have at least one year of specialized experience equivalent to the GS-5 grade level in the Federal service that includes assisting in providing basic scientific principles in carrying out scientific projects related to tobacco and/or other regulated products. -OR- One year of graduate level education in a field that is directly related to medical field, health sciences or allied science appropriate to the work of this position from an accredited college and/or university. -OR- A combination of experience as described above. -OR- Have a bachelor's degree as described in the Basic Qualification Requirements above and meet Superior Academic Achievement provision (S.A.A.) criteria. S.A.A. is based on (1) class standing, (2) grade-point average, or (3) honor society membership. Class standing -- Applicants must be in the upper third of the graduating class in the college, university, or major subdivision, based on completed courses. Grade-point average (G.P.A.) -- Applicants must have a grade-point average of: 3.0 or higher out of a possible 4.0 ("B" or better) as recorded on their official transcript, or as computed based on 4 years of education, or as computed based on courses completed during the final 2 years of the curriculum; or 3.5 or higher out of a possible 4.0 ("B+" or better) based on the average of the required courses completed in the major field or the required courses in the major field completed during the final 2 years of the curriculum. Grade-point averages are to be rounded to one decimal place. For example, 2.95 will round to 3.0 and 2.94 will round to 2.9. Election to membership in a national scholastic honor society - GS-9: Additional Requirements: Applicants must have at least one year of specialized experience equivalent to the GS-7 level in the Federal service which includes participating in gathering and analyzing requested information for scientific projects and assisting with monitoring and reviewing submissions of tobacco and/or regulated product-related information. -OR- A master's or equivalent graduate degree or 2 full years of progressively higher-level graduate education leading to such a degree in a field related to the duties of this position. -OR- A combination of experience as described above in a field related to the duties of this position that meets 100% of the qualification requirements for this position. All qualification requirements must be met by 11:59 pm (Eastern Time) on 06/12/2025. 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://secure.login.gov/, 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. Education EDUCATION: Please refer to the Qualifications above. 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. See the Application Manager Documentation for tips on submitting your paper-based documents. 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: National Association of Credential Evaluation Services (NACES) Association of International Credentials Evaluators (AICE) Credential evaluations are not free, and applicants are responsible for the cost of the selected service. For more information about this requirement, please visit the https://sites.ed.gov/international/recognition-of-foreign-qualifications/ Additional Information For some advertisements, the Food & Drug Administration receives hundreds, even thousands, of applications from job-seekers. Because of this high level of interest in positions with the FDA, the agency reserves the option of setting an application number limit. When an application limit is set, USAJOBS will close the vacancy at 11:59 pm Eastern Time on either: (A) the day the limit is reached, -OR- (B) the pre-defined closing date of 06/12/2025, whichever comes first. If the limit is reached before 11:59 pm ET, all applications in excess of the limit will continue to be accepted until 11:59 pm ET. The application limit, if applicable, for this advertisement is: 150 For more information about announcement closing, see: https://www.usajobs.gov/Help/faq/job-announcement/expiration/ Additional Conditions of Employment: Pre-employment physical required: No Drug testing required: No License required: No Mobility agreement required: No Immunization required: No Bargaining Unit: Yes, 3591 National Treasury Employees Union Telework eligible position: Telework is at the discretion of the supervisor 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. 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 06/12/2025) 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 https://www.opm.gov/frequently-asked-questions/political-appointees-and-career-civil-service-positions-faq/ for more.