Regulatory Counsel

Employer
USAJobs
Location
Washington D.C.
Posted
Oct 17, 2017
Closes
Oct 25, 2017
Function
Administrative
Hours
Full Time
JOB SUMMARY:

This position is located in the Department of Health and Human Services, Food and Drug Administration (FDA), Center for  Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Office of Generic Policy (OGDP), Division of  Legal and Regulatory Support (DLRS), located in Silver Spring, MD.

This vacancy is also being announced concurrently with vacancy announcement FDA-CDER-18-MP-2015521 under merit promotion procedures.  Please review that announcement to see if you are eligible for consideration under merit promotion procedures. 

NOTE:  Applicants must apply separately for each announcement in order to be considered.

Who May Apply: Open to all United States Citizens.

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

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TRAVEL REQUIRED:

Not required


RELOCATION AUTHORIZED:
Relocation expenses reimbursed No


KEY REQUIREMENTS:
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  • U.S. Citizenship is required.
  • Only experience gained by closing date announcement will be considered.
  • One year probationary period may be required.
  • Additional Conditions of Employment: 

    1. Security and Background Requirements:  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. 
    2. E-Verify:  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. 
    3. Direct Deposit:  All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.  
    4. Pre-employment physical required: No
    5. Drug testing required: No
    6. License required: No  
    7. Mobility agreement required: No
    8. Immunization required: No
    9. 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.
    10. Bargaining Unit Position: Yes 
    11. All qualification requirements must be met by the closing of the announcement.
    12. Financial disclosure statement required: Yes, 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.

    Minimum Qualifications:

    In order to qualify for Regulatory Counsel, 0301-13, you must meet the following: Applicant must have one year of specialized experience equivalent to at least the GS-12 grade level in the Federal service to include experience serving as a regulation and regulatory policy analyst ensuring that regulations, policies, and programs developed are consistent with statutory requirements and that scientific and medical reviews have been completed or developed.

    • If you are serving, or have served in the last 5 years (from the close of this announcement) 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.
    • If you are a veteran with preference eligibility and you are claiming 5-points veterans' preference, you must submit a copy of your DD-214 (Member Copy #4) or other proof of eligibility.  If you are claiming 10-point veterans' preference, you must also submit an SF-15, "Application for 10-Point Veterans' Preference" plus the proof required by that form.  For more information on veterans' preference see http://www.usajobs.gov/Veterans.
    • Males born after December 31, 1959 must be registered or exempt from Selective Service (see http://www.sss.gov).
    • For information on employment for People with Disabilities please visit http://opm.gov/disability/PeopleWithDisabilities.asp
    • Career Transition Program: This program applies to Federal workers whose positions have been deemed "surplus" or no longer needed, or an employee who has been involuntarily separated from a Federal service position within the competitive service.  To receive selection priority for this position, you must be rated "well-qualified".  Well-qualified means eligible applicants whose knowledge, skills, and abilities clearly exceed the minimum qualification requirements of the position.  For information on how to apply and what documents to submit as an ICTAP eligible, see: http://www.opm.gov/rif/employee_guides/career_transition.asp

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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, a review of your résumé and supporting documentation will be made and compared against your responses to the assessment questionnaire to determine if you are qualified for this job.

    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.

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

    Basis of Rating: Category rating procedures 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 assigned to one of the following quality categories: Best Qualified, Well Qualified or Qualified.

    The Category Rating Process does not add veteran's preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 10 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).

    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. Regulatory

    2. Planning and Evaluating

    3. Oral Communication

    4. Written Communication

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