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Food and Drug Administration Regulatory Counsel in Silver Spring, Maryland

Summary

This position is in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Center for Tobacco Products (CTP), Office of Regulations (OR) located in Silver Spring, MD

Responsibilities

Serve as a recognized government-wide expert in matters related to tobacco programs and is frequently called on to advise others concerning FDA statutes and regulations.

Participate in the planning for CTP's and the Agency's rulemaking and guidance development activities.

Represent the Office of Regulations, and CTP in dealing with individuals representing organizations such as the Congress, Federal agencies, State, local, and foreign governments, the regulated industry and public interest groups.

Prepare replies to correspondence from the regulated community and other interested persons on issues that are industry-wide in scope or have broad health implications and that concern precedent setting interpretations of FDA policy.

Requirements

Conditions of Employment

Qualifications

The position of Regulatory Counsel falls within the 0301 occupational series. To qualify for this position at grade GS-14, you must meet Time-in-Grade requirements by 11:59 pm EST on 04/14/2021. Time-in-Grade: Any individual who is currently holding, or has held within the previous 52 weeks, a General Schedule position under non-temporary appointment in the competitive or excepted service, must meet time-in-grade requirements (must have served 52 weeks at the next lower grade or equivalent in the Federal service). Time-in-grade requirements must be met by the closing date of this announcement. To qualify, for the GS-14: You must possess one year of specialized experience equivalent to the GS-13 grade level in the Federal service or public and private sectors which includes experience developing policies and programs involving matters affecting the regulation of tobacco, food, drug, environmental, or other regulated programs; leading policy and rulemaking work groups; writing a variety of regulatory documents that require conducting legal research and analysis. 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. PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment. 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. You must submit supporting documentation to verify your eligibility to apply for this vacancy.

For internal applicants an SF-50 will be required. If Educational requirements are listed, you must submit a Transcript, even if you occupy the series/grade in question. See the Required Documents section for full details...

Education

There is no education requirement for the Regulatory Counsel, GS-0301-14 position.

Additional Information

ADDITIONAL CONDITIONS OF EMPLOYMENT: We may make additional selections for similar positions across the entire Department of Health and Human Services (HHS) within the local commuting area(s) identified in this vacancy announcement. By applying, you agree to have your application shared with any interested selecting official(s) at HHS. There is no option to opt-out as your information will not be shared with other hiring agencies outside of HHS. Pre-employment physical required: NO Drug testing required: NO License required: NO Mobility agreement required: NO Immunization required: NO Bargaining Unit Position: YES/3591 If you are serving, or have served in the last 5 years (from 04/14/2021) 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. Political Appointees FAQ - OPM Financial disclosure statement, OGE-450, required: 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 All requirements must be met by the closing date of this announcement (04/14/2021); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the hiring process.

Additional selections may be made within the same geographical area FDA-wide.

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