Regulatory Health Project Coordinator/Manager

6 days left

Employer
USAJobs
Location
Washington D.C.
Posted
Sep 22, 2017
Closes
Sep 30, 2017
Hours
Full Time
JOB SUMMARY:

This announcement covers multiple positions with the Department of Health of Human Services (DHHS),  Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), including the following CDER offices:

The Office of New Drugs (OND) provides regulatory oversight for investigational studies during drug development, makes decisions regarding marketing approval for new drugs, including decisions related to changes to already marketed products, and provides guidance to regulated industry on a wide variety of clinical, scientific and regulatory matters. 

The Office of Translational Sciences (OTS) promotes innovation in drug regulatory review across CDER.  OTS assures the validity of clinical trial design and analysis by developing and applying quantitative and statistical approaches in the regulatory review process. 

The Office of Medical Policy Initiatives (OMPI) provides oversight and direction for new and ongoing policy initiatives in broad-based medical and clinical policy areas, including initiatives to improve the science and efficiency of clinical trials, promote clinical trial quality, and enhance patient labeling. 

The Office of Pharmaceutical Quality (OPQ) provides oversight of product quality throughout the lifecycle of a drug product and assures that quality medicines are available to the American public. 

The Office of Surveillance and Epidemiology (OSE) is responsible for monitoring the safety of drugs and therapeutic biologics used by the American people.

The Office of Generic Drugs (OGD) is responsible for the oversight and review of generic drug products. OGD is the leader in the science and regulation of generic medicines, enabling innovation in generic drug development, evaluation, and surveillance. 

This vacancy is also being announced concurrently with vacancy announcement FDA-CDER-17-MP-200615JW 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.

Learn more about this agency
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.
  • 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: No 

    In order to qualify for Regulatory Health Project Coordinator/Manager, GS-0601-12/13, you must meet the following:

    BASIC QUALIFICATIONS:

    Degree: major study in an academic field related to the health sciences or allied sciences appropriate to the work of the position.

    AND

    In addition to the basic qualification requirement described above, the following additional experience are required. Your application or resume must clearly show that you possess the specialized experience requirements.

    GS-12: Have one year of specialized experience, equivalent to the GS-11 in the Federal service, which includes serving as a project manager reviewing and evaluating regulatory requirements for the drug application process.

    GS-13: Have one year of specialized experience, equivalent to the GS-12 in the Federal service, which includes coordinating or leading scientific projects in collaboration with regulatory staff and multidisciplinary, matrix designed teams, to include clinicians, chemists, biologists, toxicologists, pharmacologists, and/or statisticians, in the drug review process; and ensuring legal, regulatory and policy requirements/compliance associated with drug development.

    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. 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.  For further information, click on foreign education.

    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. Technical Competency – Drug Review Process
    2. Planning and Evaluating
    3. Written Communications
    4. Oral Communications

    Read more Security clearance Q - Nonsensitive