This Position Is No Longer Available
  1. Overview
  2. Duties
  3. Qualifications & Evaluations
  4. Benefits & Other Info
  5. How to Apply

Job Title:REGULATORY HEALTH PROJECT COORDINATOR/MANAGER, GS-0601-12/13

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-CDER-DE-13-936862

This position is closed and no longer accepting online applications through USAJOBS.

The contents of the announcement can still be viewed.

SALARY RANGE:

$74,872.00 to $115,742.00 / Per Year

OPEN PERIOD:

Wednesday, August 07, 2013 to Tuesday, August 20, 2013

SERIES & GRADE:

GS-0601-12/13

POSITION INFORMATION:

Full Time - Permanent

PROMOTION POTENTIAL:

13

DUTY LOCATIONS:

Many vacancies in the following location:
Silver Spring, MD United StatesView Map

WHO MAY APPLY:

United States Citizens

JOB SUMMARY:

Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.

This position is located in the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of New Drug (OND). The incumbent will serve as the project coordinator/manager for a drug review team consisting of both scientific and regulatory personnel within and outside the division.

 

This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-CDER-MP-13-937113 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.

 

This job opportunity announcement may be used to fill additional vacancies.

 

KEY REQUIREMENTS

  • U.S Citizenship
  • Suitability for Federal employment determined by background investigation
  • May be required to serve a one-year probationary period

DUTIES:

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  • Serves as co-leader managing activities collaborating with the scientific co-leaders on assigned project(s).
  • Manages entire review process, including internal and external meetings, for one or more classes of drugs to ensure regulatory and policy requirements are being met.
  • Develops project plans to include setting time frames, milestones, and agreed upon completion dates.
  • Ensures the timely resolution of scientific and regulatory conflicts or problems to maintain project and performance goals.
  • Monitors the workload for the specific drug application review team.
  • Reports project activities and status for assigned projects.


QUALIFICATIONS REQUIRED:

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To qualify for this position, you must meet the Basic Requirements AND the Specialized Experience Requirements.

Basic Requirements: To qualify for any Regulatory Health Project Coordinator/Manager position in the Federal service, you must meet the description below.

Qualifying degree program - Successfully completed a full four-year course of study in an accredited college or university leading to a bachelor's or higher degree with a major study in an academic field related to health sciences or allied sciences appropriate to the work of the position, such as biology, chemistry, biochemistry, pharmacology, epidemiology, or other related biological and medical sciences. (You must provide a copy of your trnascript at time of application submission)

AND


Specialized Experience Requirements: In addition to meeting the Basic Requirements described above, your resume must demonstrate that you satisfy the Specialized Experience Requirements of each grade level for which you wish to receive consideration. 
 

GS-12: You must have at least one year of specialized experience, equivalent to the GS-11 or higher grade level in the Federal service that included reviewing drug development applications; coordinating the activities of projects to include monitoring, tracking, and reporting of information; and using spreadsheet software to retrieve and analyze data.

 

GS-13: You must have at least one year of specialized experience, equivalent to the GS-12 or higher grade level in the Federal service that included providing technical advice and counsel on FDA regulations, policies, and legislations relating to the drug development approval process; managing and/or leading projects to include managing resources, assigning work, resolving conflicts, and representing the team; and writing technical documents in support of regulatory projects.   

 


You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.  Degree requirements must be met within 30 days of the closing date of this job announcement and your transcript(s) submitted must reflect this.

 

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.  For further information, click on foreign education.

 

Failure to provide any of the above will result in an ineligible rating.  

 

Conditions of Employment:

1. Security and Background Requirements: If not previously completed, a background security investigation will be required for all appointees.  Appointment will be subject to the applicant's successful completion of a background security investigation and favorable adjudication.  Failure to successfully meet these requirements may be grounds for appropriate personnel action.  In addition, 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 and/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. All qualification requirements must be met by the closing date of the announcement.

 

5. Financial disclosure statement may be required.

 

6. One-year probationary period may be required.

 

7. Travel, transportation, and relocation expenses will be paid:  No

 

8. Bargaining Unit Position: Yes 

 

9. Drug Screening Required:  No

 

10. Recruitment incentives may be authorized:  No  

 

11. Student loan repayment incentive authorized:  Maybe 

 

12. Annual leave for non-federal service authorized:  No

 

HOW YOU WILL BE EVALUATED:

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 résumé and supporting documentation, a determination is made that you have inflated your responses when compared to your background information, 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.

 

Candidates who meet the Basic and Specialized Experience requirements, will be assigned to the following quality categories:

 

Best Qualified - Meets the minimum qualification requirements and excels in most requirements of the position.

 

Well Qualified - Meets the minimum qualification requirements and meets most requirements of the position.

 

Qualified - Meet the minimum qualification requirements, but does not possess the relevant competencies to a substantive degree. 

 

The category assignment is a measure of the degree in which your background matches the required competencies listed below:

 

  • FDA regulations and policies relating to the drug approval processes, and/or pharmaceutical discovery or manufacturing processes
  • Project Management
  • Problem Solving
  • Oral Communication
  • Written Communication
  •  

    Application of Veterans' Preference: Under Category Rating procedures, veteran preference eligibles will receive selection consideration before non-preference eligibles within each quality category.

    To preview the assessment questionnaire, click the following link:View Assessment Questions


    BENEFITS:

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    The Federal government offers a comprehensive benefits package.  Explore the major benefits offered to most Federal employees at http://www.opm.gov/retire/retire_jobseekers.asp.



    OTHER INFORMATION:

    Veterans' Preference: If you are a veteran claiming 5-point veterans' preference, you must submit a copy of your DD-214 (Member Copy 4) or an official statement (including Character of Service) from your command if currently on active duty. If you are claiming 10-point veterans' preference, in addition to the DD-214, you must also submit a Standard Form 15 (Application for 10-Point Veteran Preference) and the required supporting documents listed on that form.  For more information on veterans' preference see www.fedshirevets.gov. 

     

    Career Transition Program:  This program applies to Federal workers whose positions have been deemed 'surplus' or no longer needed, or an employee 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. For information on how to apply and what documents to submit as a CTAP/ICTAP eligible, go to: http://www.opm.gov/rif/employee_guides/career_transition.asp

    Selective Service:  The Defense Authorization Act of 1986 requires that all male applicants born after 12/31/59 who are required to register under the Military Selective Service Act, be registered or they are not eligible for appointment to this position.  For further information concerning Selective Service requirements, please visit http://www.sss.gov/.



    HOW TO APPLY:

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    Click the Apply Online button to create an account or log in to your existing USAJOBS account.  Follow the prompts to complete the on-line assessment questionnaire. Please ensure you click the Submit My Answers button at the end of the process.

     

    Note: To return to your saved application materials, log in at: https://applicationmanager.gov/ and click on 936862.

     

    If you cannot apply online, you will need to:

    1) Print the instructions and questionnaire by clicking View Occupational Questionnaire.

    2) Print the 1203FX form to record your responses to the questionnaire.

    3) Fax the completed 1203FX (all 6 pages but do not include a Cover Page for this document) to:  1-478-757-3144.

    4) Print the Fax Cover Page and include with any supporting documents you fax (e.g., résumé, transcripts, veterans documentation, etc.) to the same fax number above.

     

    Please do not complete steps 1-4 above if you are applying on-line.



    REQUIRED DOCUMENTS:

    • Your Résumé - You are encouraged to use the USAJobs online resume builder to ensure that all required information is in your resume. If you use your own résumé, curriculum vitae, or any other written form you choose then you must describe your job-related qualifications that include beginning and ending dates for paid and non-paid work experience, hours worked per week, month and year of employment for each job title listed.
    • Responses to the Assessment Questionnaire
    • College transcripts that support the required degree

     

    Other Supporting Documents: (Only submit if applicable to you.)

      

  • Veterans' Preference documentation (i.e. SF-15, DD-214, Statement of Service, Service Connected Disability Letter, etc. ) 
  • CTAP/ICTAP documentation
  •  

    APPLICATION MATERIALS MUST BE RECEIVED BY MIDNIGHT (EASTERN TIME) ON THE CLOSING DATE OF THIS ANNOUNCEMENT

     

    For Résumé and Application Tips visit: http://www.usajobs.gov/ResourceCenter/Index/Interactive/ResumeAndApplicationTips#icc

    AGENCY CONTACT INFO:

    Mid-Atlantic Services Branch
    Phone: (757)441-6765
    Email: NORFOLKMAIL@OPM.GOV
    Agency Information:
    HHS OPM
    1900 E St NW
    Washington, DC
    20415

    WHAT TO EXPECT NEXT:

    You will be notified of your status when the list of candidates has been referred to the hiring manager for employment consideration.  


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    Job Announcement Number:

    HHS-FDA-CDER-DE-13-936862

    Control Number:

    348837700