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

Job Title:Regulatory Counsel, GS-301-15

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-DE-13-941326

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

The contents of the announcement can still be viewed.

SALARY RANGE:

$123,758.00 to $155,550.00 / Per Year

OPEN PERIOD:

Wednesday, August 14, 2013 to Wednesday, August 21, 2013

SERIES & GRADE:

GS-0301-15

POSITION INFORMATION:

Full Time - Permanent

PROMOTION POTENTIAL:

15

DUTY LOCATIONS:

1 vacancy 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 Department of Health of Human Services (DHHS), Food and Drug Administration (FDA), Office of the Commissioner (OC), Office of the Chief Scientist, Office of Scientific Integrity in Silver Spring, Maryland.

 

Who May Apply:  Open to all United States Citizens.

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KEY REQUIREMENTS

  • U.S. Citizenship is required.
  • Background investigation required.
  • One year probationary period may be required.

DUTIES:

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If selected for this position, you will perform the following duties:

 

Develop policies and practices to protect and promote integrity in the Agency’s scientific decisions and processes.

Represent the Agency and Chief Scientist to external governmental and non-governmental groups and activities that address and develop scientific integrity and dispute resolution policies and activities.

 

Lead ad hoc reviews of allegations of inappropriate actions, reaching conclusions about their merit, recommending appropriate agency responses, and managing communication with outside parties.

 

Ensure consistency of processes for like functions throughout the agency.

 

Work internally and with external stakeholders, as appropriate to identify areas at Food and Drug Administration (FDA) that need improvement, to assess best practices, and to build support for the agency’s programs and mission.

 

Lead efforts to develop or improve processes and/or practices for critical agency programs or initiatives where such processes may be lacking, ineffective, or incomplete.

 

Work with senior leadership and appropriate officials at the Department level to implement policy initiatives, to include but not limited to foods, veterinary drugs, the nation's food supply, tobacco, and cosmetics, and ensure that the necessary practices, procedure and documents are developed to put forth those initiatives.

 

 

 

 

 

 


QUALIFICATIONS REQUIRED:

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You must have one (1) year of specialized experience, equivalent to the next lower grade level that has equipped you with the particular knowledge, skills and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled.

 

To qualify for this position at the GS-15 grade level, you must have at least one full year of specialized experience equivalent to the GS-14 grade level or equivalent that includes directing or overseeing a subordinate staff performing assignments of a national scope resolving issues concerning scientific matters related to appeals, disputes, requests for review/hearings regarding Food, Drug, Devices, Tobacco or Biologics based regulatory matters, information and decisions.  Experience working with scientists, attorneys and/or policymakers in analyzing and developing Food, Drug, Devices, Tobacco or Biologics regulations, policies and procedures for reviewing appeals, requests or disputes and overseeing the resolution of informal disputes.


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 further information, visit: http://www.ed.gov.

 

 

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. Travel, transportation, and relocation expenses may be paid, subject to availability of funds: No 

 

7. Bargaining Unit Position: No

 

8. Drug Screening Required: No

 

9. Recruitment incentives may be authorized, subject to availability of funds: No 

 

10. Student loan repayment incentive may be authorized, subject to availability of funds: No 

 

11. 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.

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.

 

Best Qualified – Applicants who have experience that is almost identical to those required by the position, including any quality ranking factors identified.

Well Qualified – Applicants who have experience that is very similar to those required by the position.

Qualified – Applicants who meet minimum qualification requirements, but do not identify any additional qualifying experience or skill.

The Category Rating Process does not add veterans’ 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 KSA’s. 

 

Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics).   

 

 

 

Required Knowledge, Skills, and Abilities (KSAs):

    1.  Knowledge of laws, legislation, policies and guidelines related to regulatory programs in Food, Drug, Devices, Tobacco or Biologics and public health relevant to food and drug law and matters concerning protection of human subjects and assurance of research integrity.

    2.  Ability to research, evaluate and analyze facts and legal information, formulating conclusions.

    3.  Skill in analyzing and resolving disputes or differences about Food, Drug, Devices, Tobacco or Biologics related and regulatory determinations.

    4.  Ability to foster cooperative working relationships.

    5.  Ability to provide oversight, leadership, and technical expertise in the development and implementation and regulatory policy, related to Food, Drug, Devices, Tobacco or Biologics.

    6.  Skill in written communication.

 

 

 


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.usajobs.gov/ResourceCenter/Index/Interactive/Benefits#icc.



OTHER INFORMATION:

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 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 "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



HOW TO APPLY:

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To apply for this position, you must complete the occupational questionnaire and submit the documentation specified in the Required Documents section below.

The complete application package must be submitted by 11:59 PM (EST) on Wednesday, August 21, 2013 to receive consideration.

  • To begin, click Apply Online to create a USAJOBS account or log in to your existing account. Follow the prompts to select your USAJOBS resume and/or other supporting documents and complete the occupational questionnaire.
  • Click the Submit My Answers button to submit your application package.
  • It is your responsibility to ensure your responses and appropriate documentation are 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.
  • To return to an incomplete application, log into your USAJOBS account and click Update Application in the vacancy announcement.  You must re-select your resume and/or other documents from your USAJOBS account or your application will be incomplete.
  • 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.

 



REQUIRED DOCUMENTS:

All applicants are required to submit the following supporting document type(s):
   ·Resume

Applicants may also submit the following supporting document type(s),which may not be required for all applicants:
   ·DD-214
   ·Other Veterans Document
   ·SF-15
   ·Transcript

 

Other Supporting Documents:  (only submit if applicable)

·        College transcripts (unofficial copy acceptable)

·        Veterans’ Preference documentation (e.g., DD-214 which shows type of discharge/character of service, SF-15, VA letter, etc.)

CTAP/ICTAP documentation

Faxing Applications or Supporting Documents:

You are encouraged to apply online.  Applying online will allow you to review and track the status of your application.

NOTE:  If you applied online and your application is complete, do not fax the paper application (1203FX) as this will overwrite your prior online responses and may result in you being found ineligible.

If you completed the occupational questionnaire online and are unable to upload supporting document(s):

1. To fax your documents, you must use the following cover page http://staffing.opm.gov/pdf/usascover.pdf and provide the required information.  The Vacancy ID is 941326.

2. Fax your documents to 1-478-757-3144.

If you cannot complete the Application Package online, you may fax all of your materials.  The complete application package must be submitted by 11:59 PM (EST) on Wednesday, August 21, 2013  to receive consideration.  Keep a copy of your fax confirmation in the event verification is needed.

To complete the occupational questionnaire and submit via fax:

1. Click the following link to view and print the occupational questionnaire View Occupational Questionnaire.

2. Print the 1203FX form, follow the instructions and provide your responses to the occupational questionnaire items http://www.opm.gov/forms/pdfimage/opm1203fx.pdf

3. Fax the completed 1203FX form along with any supporting documents to 1-478-757-3144.  Your 1203FX will serve as a cover page for your fax transmission.

4. This agency provides reasonable accommodation to applicants with disabilities.  If you need a reasonable accommodation for any part of the application and hiring process, please contact the Bethesda Customer HelpDesk at (888) 478-4340; TTY/TDD: (800) 877-8339; or by email quickquestions@psc.gov.  The decision on granting reasonable accommodation will be made on a case-by-case basis.

For Résumé and Application Tips visit: https://help.usajobs.gov/index.php/Tips.

AGENCY CONTACT INFO:

FDA Helpdesk
Phone: (888)478-4340
Fax: (478)757-3144
Email: QUICKQUESTIONS@PSC.GOV
Agency Information:
HHS FDA Center
10903 New Hampshire Avenue
Silver Spring, MD
20993 Fax: (478)757-3144

WHAT TO EXPECT NEXT:

Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful.  The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview.  We expect to make a selection within 45 days of the closing date of this announcement. Once this process is completed, you will be notified of your status via e-mail.

 


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Job Announcement Number:

HHS-FDA-DE-13-941326

Control Number:

349337300