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

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-CTP-MP-14-975056

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

The contents of the announcement can still be viewed.

SALARY RANGE:

$89,033.00 to $115,742.00 / Per Year

OPEN PERIOD:

Friday, October 25, 2013 to Thursday, November 07, 2013

SERIES & GRADE:

GS-0301-13

POSITION INFORMATION:

Full Time - Agency Employees Only

PROMOTION POTENTIAL:

13

DUTY LOCATIONS:

3 vacancies in the following location:
Rockville, MD View Map

WHO MAY APPLY:

Food and Drug Administration (FDA) Employees and Career Transition Assistance Plan (CTAP) Eligibles in the Local Commuting Area Only

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.

Join HHS/FDA/Center for Tobacco Products (CTP) and help make our world healthier, safer, and better for all Americans.  CTP is the newest arm of the FDA.  CTP is the principal Federal agency charged to establish tobacco regulations in order to decrease the tremendous toll of diseases, disability and death caused by tobacco use in the United States.

 

Who May Apply:  This vacancy is open to current Food and Drug Administration (FDA) employees with competitive status and CTAP Eligibles in the Local Commuting Area only.  Competitive status refers to employees who are serving on a career or career conditional appointment.

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 YOUR SF-50 AND/OR CTAP Documentation. 

This position is located in the U. S. Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Center for Tobacco Products (CTP), Office of Compliance and Enforcement (OCE), Rockville, Maryland.

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

KEY REQUIREMENTS

  • U.S. Citizenship is required.

DUTIES:

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    Conduct or coordinate the analyses of the impact of proposed changes to FDA laws and regulations that affect the functions, program segments and compliance activities in the Office of Compliance and Enforcement (OCE).

    Interpret and evaluate CTP's compliance efforts; as directed, establish compliance policy and make recommendations to Senior Regulatory Counsels and Center Management.  Develop policies and programs involving the most complex and highest priority matters affecting the compliance of tobacco products.

    •Perform review of enforcement and compliance actions, as instructed, for completeness and adherence to all rules, regulations, policy, and legal decisions.

    •Develop and draft a wide range of regulatory and compliance policy documents, often leading working groups within the Center and participating on behalf of CTP on Agency-wide groups or teams.

    • Make presentations at conferences and professional meetings in the U.S. and overseas before the regulated industry, clinical investigators, and the medical/scientific community on the applicable regulations and compliance policies.  Provide guidance and/or training to regulatory specialists and other professionals within FDA on matters relating to his/her expertise.

    • Prepare replies to correspondence from the regulated community and other interested persons on issues that are industry-wide in scope or have broad health implications and that concern precedent setting interpretations of FDA policy.

    •Other duties related to compliance and enforcement procedures, as assigned.


QUALIFICATIONS REQUIRED:

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Have at least one year of specialized experience, equivalent to the GS-12 grade level in the Federal service, planning, analyzing or researching issues to evaluate the effect of laws and regulations on tobacco products; or drafting and/or commenting on proposed compliance policy; or reviewing and drafting compliance and guidance documents.

Documenting experience:  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.


Conditions of Employment:

1. Additional Security and Background Requirements:  May be referred depending on the position being filled.  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. All qualification requirements must be met by the closing date of the announcement. 

3. Financial disclosure statement required: No 

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

5. Bargaining Unit Position: Yes  

6. Drug Screening Required: No 

7. Recruitment Bonus may be authorized: No 

8. Research position: No  

9. Supervisory position: No  

10. Time in grade must be met within 30 days of the closing date of the announcement. 

11. License Required: No

12. Mobility Agreement Required: No

13. Immunization Required: No

14. Travel Required: No

15. Moving Expenses Authorized: No

16. Relocation Incentive Authorized: No

17. Recruitment Incentive Authorized: No

18. Student Loan Repayment Incentive Authorized:No

19. Annual Leave for Non-Federal Service Authorized: No

HOW YOU WILL BE EVALUATED:

Once the application process is complete, a review of the resume 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 qualifications and/or experience, you may lose consideration for this position.  Please follow all instructions carefully.  Errors or omissions may affect your eligibility. Merit Promotion Procedures for the Food and Drug Administration (FDA) 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 ranked into one of two categories:  Best Qualified or Qualified.

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

1. Knowledge of legislation, laws, precedents, and regulations in order to ensure that compliance documents and policies developed are consistent with statutory requirements and existing policy.

2. Skill in analyzing information, formulating conclusions and setting forth recommendations.

3. Skill in interpersonal relationships.

4. Skill in oral communication.

5. 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:

Males born after December 31, 1959 must be registered or exempt from Selective Service (see http://www.sss.gov



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 Thursday, November 07, 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 is 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.


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:
   ·Cover Letter
   ·SF-50

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 975056.

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 Thursday, November 07, 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.

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.


You will receive notice via email or by mail, if no email address was provided by you during the application process, once this process is completed (generally 4-6 weeks).


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Job Announcement Number:

HHS-FDA-CTP-MP-14-975056

Control Number:

353120800