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-0301-14

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-CDER-DE-13-924249

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

The contents of the announcement can still be viewed.

SALARY RANGE:

$105,211.00 to $136,771.00 / Per Year

OPEN PERIOD:

Monday, July 29, 2013 to Monday, August 19, 2013

SERIES & GRADE:

GS-0301-14

POSITION INFORMATION:

Full Time - Permanent

PROMOTION POTENTIAL:

14

DUTY LOCATIONS:

Few 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 Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Silver Spring, MD. 

 

This vacancy covers the Office of Scientific Investigations (OSI) and Office of Unapproved Drugs & Labeling Compliance (OUDLC), Silver Spring, MD.

 

The Office of Scientific Investigations (OSI) develops policies, surveillance activities, and compliance strategies relating to nonclinical and clinical drug product studies, bioequivalence studies, human subject protections, post-market Adverse Drug Experience reporting requirements, Risk Evaluation and Mitigation Strategies, and commitments for Postmarketing Requirements.

 

The Office of Unapproved Drugs & Labeling Compliance (OUDCL) develops policies and compliance strategies for protecting the public health by assuring compliance with the new drug and misbranding requirements of the Federal Food, Drug and Cosmetic Act.

 

This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-CDER-MP-13-928126 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.

This announcement may be used to fill additional vacancies.

KEY REQUIREMENTS

  • U.S. Citizenship is required.
  • Background investigation required.
  • Only experience gained by closing date announcement will be considered.
  • One year probationary period may be required.

DUTIES:

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The incumbent will serve as a Senior Regulatory Counsel resolving a broad range of legal/regulatory issues concerning the application of Food and Drug Administration's enabling legislation, pertinent regulations, and/or general legislation affecting the operation of the federal government.

Work with the team and the Division to develop and revise policies, programs,  regulations, and guidance documents involving the most complex and highest priority matters affecting drug compliance.

Perform legal/regulatory reviews of petitions raising issues that have an industry-wide effect, as well as those that pertain to the marketing status of individual products.

Drafts and performs legal/regulatory reviews of action packages for enforcement actions, including Warning Letters and seizure and injunction referrals.

Make presentations at conferences and professional meetings in the U.S. and overseas before the regulated industry and the professional community on the applicable regulations and policies.


QUALIFICATIONS REQUIRED:

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Qualification Requirement:

 

GS-14:  Have at least one year of specialized experience, equivalent to the GS-13 level in the Federal service, conducting legal analyses invovling statutes, regulations, policies, and procedures affecting regulatory programs such as food and drug, healthcare, environment, or other regulatory programs; drafting and/or commenting on policy and regulations. 


 

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. Certain positions within the FDA are subject to restrictions on financial holdings specifically FDA regulated financial holdings.  This position could be subject to these restrictions.  During the application and interview process, and prior to accepting this position, we advise applicants to seek additional information from the FDA Ethics Office at (301) 827-5511.

  

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

 

7. Bargaining Unit Position: Yes

 

8. Drug Screening Required: No

 

9. Recruitment incentives may be authorized: No

 

10. Student loan repayment incentive authorized: No

 

11. Annual leave for non-federal service authorized: May be authorized

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 the Federal Food, Drug, & Cosmetic Act involving implementing regulations.

 

2.  Ability to communicate orally.

 

3.  Ability to communicate in writing.


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 Monday, August 19, 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:
   ·Cover Letter
   ·DD-214
   ·OF-306
   ·Other Veterans Document
   ·SF-15
   ·SF-50
   ·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 924249.

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 Monday, August 19, 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-CDER-DE-13-924249

Control Number:

347875400