Senior Advisor-Regulatory

Employer
USAJobs
Location
Washington D.C.
Posted
May 23, 2018
Closes
May 23, 2018
Function
Administrative
Hours
Full Time
TRAVEL REQUIRED:

Not required


RELOCATION AUTHORIZED:
Relocation expenses reimbursed No


KEY REQUIREMENTS:
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  • Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement.
  • Time-in-Grade Requirement: If you are applying as a current Federal employee, you must meet the time-in-grade requirements described in the Qualifications section, generally, 52-weeks of comparable experience at the next lowest grade.
  • Selective Service Registration: All males born on, or after, 12/31/1959, must be registered with the Selective Service OR have an approved exemption.
  • FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the problem.
  • Security and Background Requirements: Appointment will require passing a background investigation. Not meeting this requirement may be grounds for personnel action. If hired, you may be subject to a background check at a later time.
  • Certification of Accuracy: All information concerning qualification for employment is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection or appropriate disciplinary action.
  • Direct Deposit: You will be required to have your federal salary payments electronically deposited into an account with a financial institution of your choice.
  • You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and time-in-grade qualifications attained by this date will be considered.
  • In order to qualify for Senior Advisor-Regulatory, 0401/0403/1320, at GS - 15, you must meet Time-in-Grade requirements by 05/22/2018.

    Applicants must demonstrate that they meet the basic requirement for the desired occupational series AND the specialized experience requirement.

    Basic Requirement:

    Biologist GS- 401:


    Degree: biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position.

    OR

    Combination of education and experience: Courses equivalent to a major, as shown above, plus appropriate experience or additional education.

    Microbiologist GS- 403:

    Degree: microbiology; or biology, chemistry, or basic medical science that included at least 20 semester hours in microbiology and other subjects related to the study of microorganisms, and 20 semester hours in the physical and mathematical sciences combining course work in organic chemistry or biochemistry, physics, and college algebra, or their equivalent.

    OR

    Combination of education and experience--courses equivalent to a major in microbiology, biology, chemistry, or basic medical science that included courses as shown above, plus appropriate experience or additional education.

    Chemistry GS- 1320:

    Degree: physical sciences, life sciences, or engineering that included 30 semester hours in chemistry, supplemented by course work in mathematics through differential and integral calculus, and at least 6 semester hours of physics.

    OR

    Combination of education and experience -- course work equivalent to a major as shown in A above, including at least 30 semester hours in chemistry, supplemented by mathematics through differential and integral calculus, and at least 6 semester hours of physics, plus appropriate experience or additional education.

    AND
    In addition to the basic qualification requirement, you must also meet the following:

    Have one year of specialized experience, equivalent to the GS- 14 in the Federal service, to include performing review of technical or complex regulatory submissions for vaccines and related biological product in accordance with applicable federal law and regulations; providing advice and assistance to senior management in developing and implementing regulatory policy and guidance; assisting in providing managerial direction of a highly technical staff involved in the regulation of vaccines and related biological products; and providing leadership on broad scientific and regulatory activities involving the regulation of vaccines and related biological products.


    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.

    You must submit documentation to verify your eligibility to apply for this vacancy. For most applicants, an SF-50 will be required. However, if you are applying based as a Veteran, person with a disability, or a displaced former employee, you will be required to provide other supporting documents as applicable. See the Required Documents section for more details.

    If you are claiming education as any part of your qualifications for this position, you must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.

    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 more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.

    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 Position: NO
    • If you are serving, or have served in the last 5 years (from 05/22/2018) 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
    All requirements must be met by the closing date of this announcement (05/22/2018); only education and experience gained by this date will be considered.

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    You will be evaluated for this job based on how well you meet the qualifications above.

    Once the job opportunity announcement closes (at 11:59 pm ET on 05/22/2018), a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for this internal position. Eligible internal candidates will be referred to the hiring official for consideration.

    Please follow all instructions carefully. Errors or omissions may affect your eligibility.

    Basis of Rating: Merit Promotion Procedures for the Food and Drug Administration (FDA) will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be ranked into one of two categories: Best Qualified or Qualified.

    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.

    1. Leadership
    2. Technical Competence
    3. Oral Communication
    4. Written Communication
    To review the application questionnaire, click the link below.
    https://apply.usastaffing.gov/ViewQuestionnaire/10199511

    Read more Security clearance Q - Nonsensitive


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