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-301-12/13

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-ORA-MP-13-881902

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:

Monday, April 29, 2013 to Friday, May 17, 2013

SERIES & GRADE:

GS-0301-12/13

POSITION INFORMATION:

Full Time - Permanent

PROMOTION POTENTIAL:

13

DUTY LOCATIONS:

Few vacancies in the following location:
Montgomery County, MD United StatesView Map

WHO MAY APPLY:

FDA - WIDE

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.

The FDA's Office of Regulatory Affairs is the lead office for all FDA Field activities as well as providing FDA leadership on imports, inspections, and enforcement policy.  ORA supports FDA Product Centers by inspecting regulated products and manufacturers, conducting sample analysis on regulated products, and reviewing imported products offered for entry into the United States.  ORA also develops FDA-wide policy on compliance and enforcement.

WHO MAY APPLY:  This vacancy is open to current permanent (career/career-conditional appointments) employees of the Food and Drug Administration (FDA) ONLY.  Current FDA employees serving under a Schedule-A OR VRA appointment are eligible for consideration. Title 42 employees not eligible for reinstatement will not be considered. 

YOU MUST SUBMIT YOUR SF-50 (Notification of Personnel Action)

Current FDA 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 the selecting official as Commissioned Corps (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.

LOCATION:  This position is located in the Food and Drug Administration, Office of Global Regulatory Operations and Policy, Office of Regulatory Affairs, Office of Policy and Risk Management located in Montgomery County, Maryland.

   

The salary listed in the vacancy announcement includes the geographical locality pay. 

TYPE OF POSITION: This position is being filled on a full-time, permanent basis.
PROMOTION POTENTIAL: This is a career-ladder position; GS-13 is the full performance level.
Additional selections may be made from this announcement.

KEY REQUIREMENTS

  • U.S. Citizenship required.
  • All application materials must be received by the closing date.
  • Please carefully read and follow the instructions for HOW TO APPLY.
  • Must meet time-in-grade requirement within 30 days of the closing date.

DUTIES:

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The incumbent of this position serves as a regulations and regulatory policy analyst in the Office of Regulatory Affairs (ORA).   The incumbent assumes primary responsibility for ensuring that regulations and policies developed in the assigned areas are consistent with statutory requirements and existing policy, their need is justified, and that adequate scientific and medical reviews have been completed.

At the full performance level, the incumbent performs duties that include resolving a broad range of issues concerning the application of any of FDA's enabling legislation, pertinent regulations, and/or general legislation affecting the operation of the Federal government.   Assignments involve researching regulatory issues and revising existing or creating new policies and regulations.   Major duties include:

      Develops policies and programs involving complex and high priority matters affecting the all program areas within regulation of the Office’s program responsibility.   Drafts or critically reviews documents embodying policy and program proposals and decisions on these products.

·     Serves as a regulatory expert in matters related to his/her area of responsibility and is frequently called on to advise others, both internal and external to FDA, concerning FDA statutes, regulation, and policy. 

     Drafts or reviews proposals for new regulations and policy statements involving his or her area of regulatory expertise.   These regulations and policy statements often result from the need to implement new legislation or from new interpretations of existing legislation.

      Reviews, summarizes, and drafts responses to all public comments received on proposed regulations; recommends adoption or rejection of counter-proposals contained in comments and objections; drafts final regulations.

      Reviews petitions raising issues that affect a segment of the regulated industry as well as those that pertain to the marketing status of individual products.   Develops a course of action and drafts responses to such petitions.

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

·     May make presentations at conferences and professional meetings before the regulated industry, clinical investigators, and the medical/scientific community on the applicable regulations and policies.

Duties at the trainee levels will be selected by the supervisor and will be developmental in nature.


QUALIFICATIONS REQUIRED:

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Applicants must meet all qualification requirements by the closing date of this vacancy announcement:

GS-12: one year of specialized experience at least equivalent to the GS-11 level of Federal service. 

GS-13: one year of specialized experience at least equivalent to the GS-12 level of Federal service. 

SPECIALIZED EXPERIENCE:   Experience directly related to the position to be filled which has equipped the candidate with the particular knowledge, skills, and abilities needed to successfully perform the duties of the position, and that is typically in or related to the position to be filled which includes knowledge of program and data management; in-depth experience in analyzing policies and procedures; reviewing and modifying policy and/or procedures to promote the efficiency and effectiveness of programs; and experience identifying problems in program areas and implementing or recommending solutions. 

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.

TIME-IN-GRADE REQUIREMENT:  In addition to the specialized experience requirement, applicants must meet the following time-in-grade requirement within 30 days of the closing date of this announcement.

GS-12: Applicants must have 52 weeks at the GS-11 or higher.  

GS-13: Applicants must have 52 weeks at the GS-12 or higher


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. Direct Deposit:  All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing. 
3. All qualification requirements must be met by the closing date of the announcement. 
4. Financial disclosure statement may be required. 
5. Travel, transportation, and relocation expenses will not be paid. 
6. Bargaining Unit Position: No
7. Drug Screening Required: No 
8. Travel required:  No
9. Certain positions within the FDA are subject to restrictions on financial holdings (FDA regulated financial holdings).  To determine whether this position is affected, applicants are advised to seek additional information during the interview process from the Ethics and Integrity Staff, Office of Management Programs, Office of Management at (301) 796-8440 prior to accepting such a position.

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. 

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

1.   Expert knowledge of the various titles of law applicable to the Office of Regulatory Affairs and FDA mission, Federal laws governing or affecting the program, Federal regulations, and significant national and local developments in the field.

2.   Knowledge of pertinent regulatory information in agency manuals, reference systems, directives, issuances, precedent decisions, court decisions, and commercial publications.

3.   Ability to communicate orally.

4.   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:

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 Assistance Program (CTAP):  For information on how to apply as a CTAP eligible see http://opm.gov/rif/employee_guides/career_transition.asp#ctap.  To be well-qualified and exercise selection priority for this vacancy, displaced Federal employees must be rated at 85.0 or above on the rating criteria for this position.

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.asp.

 



HOW TO APPLY:

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To begin the process, click the Apply Online button to create an account or log in to your existing USAJOBS account. Follow the prompts to complete the assessment questionnaire.  Please ensure you click the Submit My Answers button at the end of the process.  Note:  To return to a previously saved or incomplete application you may use the following link:  https://applicationmanager.gov

To fax supporting documents you are unable to upload, complete this cover page http://staffing.opm.gov/pdf/usascover.pdf using the following Vacancy ID 881902.  Fax your documents to 1-478-757-3144

If you cannot apply online:

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

2. Print this 1203FX form to provide your response to the assessment questionnaire http://www.opm.gov/forms/pdf_fill/OPM1203fx.pdf and

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. 

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 Center HelpDesk Telephone (888)-478-4340; TTY/TDD: (866)-539-4484; or by email quickquestions@psc.gov .  The decision on granting reasonable accommodation will be made on a case-by-case basis.



REQUIRED DOCUMENTS:

To apply for this position, you must provide a complete Application Package which includes:
  1. 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.
  2. A complete Assessment Questionnaire
  3. Other supporting documents:
        • SF-50 (if you are a federal employee or have reinstatement rights as a federal employee)
        • PHS Commissioned Corps Officer must submit a copy of latest personnel order
        • College Transcripts (if the position has a positive education requirement)

Note:  You may submit an unofficial transcript or a list of college courses completed indicating course titles, credit hours, and grades received.  An official transcript from an accredited educational institution is required if you are selected for the position. 

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

The complete Application Package must be submitted by 11:59 PM (EST) on Friday, May 17, 2013.

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-ORA-MP-13-881902

Control Number:

342437400