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

Job Title:Regulatory Information Specialist

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-MP-13-868561

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:

Tuesday, April 02, 2013 to Tuesday, April 16, 2013

SERIES & GRADE:

GS-0301-12/13

POSITION INFORMATION:

Full Time - Permanent

PROMOTION POTENTIAL:

13

DUTY LOCATIONS:

1 vacancy in the following location:
Rockville, MD United StatesView Map

WHO MAY APPLY:

Status Candidates (Merit Promotion and VEOA Eligibles)

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.

Who May Apply:  Federal employees with career or career-conditional appointments in the competitive service; former Federal employees with reinstatement eligibility based on previous career or career-conditional appointments; displaced Federal employees requesting special priority selection consideration under the Career Transition Assistance Plan (CTAP) and the Interagency Career Transition Assistance Program (ICTAP); veterans who are preference eligibles or who have been separated under honorable conditions after 3 years or more of continuous active service; Military Spouses; PHS Commissioned Corps Officers; individuals eligible for VRA appointments (at the GS-11 and below grade levels); and individuals with disabilities.

This position is located in the Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Office of Communication, Outreach and Development (OCOD), Division of Communication and Consumer Affairs (DCCA), Communication Technology Branch (CTB). The incumbent of this position is responsible for managing an internet based regulatory health information system covering the products and establishments regulated by the Center, which includes conducting quality assurance review of information.

This announcement may be used to fill multiple positions in multiple locations.

KEY REQUIREMENTS

  • U.S. Citizenship is required.
  • Time in Grade

DUTIES:

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Major Duties:

  • Provides oversight of an internet based regulatory and health information products information system.
  • Coordinates and provides periodic and specific reports related to regulatory review activities.
  • Analyzes information contained in system/database and extract requested information in report form.
  • Analyzes current and projected needs for enhancing the Internet system.
  • Troubleshoots information in the system in order to validate accuracy.
  • Provides information in response to FOI and congressional inquiries.
  • Prepares instructional material.
  • Provides information on a variety of topics associated with the regulatory review process and user fee requirements.
  • Provides quality assurance pertaining to the integrity and accuracy of existing and new scientific and regulatory information added to the system using web coding such as HTML and Dreamweaver.
  • Reviews web content information and identify contradictions relating to 508 compliance.
  • Provide solutions geared towards improving regulatory communication.
  • Delivers training to a variety of users using acceptable methods and techniques.
  • Ensures system and enhancements are easily accessible to a variety of users such as Agency personnel and the public.


QUALIFICATIONS REQUIRED:

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To qualify at the grade GS-12: Applicants must have at least one full year of specialized experience comparable in scope and responsibility to at least the GS-11 level in the Federal service (this experience can be obtained in either the public or private sectors). Examples of specialized experience include, providing information on a variety of topics associated with the regulatory review process and user fee requirements as it relates to internet initiatives. Providing quality assurance pertaining to the integrity and accuracy of existing and new scientific and regulatory information added to a web based system using web coding such as HTML and Dreamweaver. Reviewing web content information and identify contradictions relating to 508 compliance. Delivering training to a variety of end- users using acceptable methods and techniques.

To qualify at the grade GS-13: Applicants must have at least one full year of specialized experience comparable in scope and responsibility to at least the GS-12 level in the Federal service (this experience can be obtained in either the public or private sectors). Examples of specialized experience include, providing expert advice on a variety of topics associated with the regulatory review process and user fee requirements as it relates to internet initiatives. Providing guidance and assistance to others on complex requests regarding quality assurance pertaining to the integrity and accuracy of existing and new scientific and regulatory information added to a web based system using web coding such as HTML and Dreamweaver. Reviewing web content information and identify contradictions relating to 508 compliance. Delivering training to a variety of end-users using acceptable methods and techniques.

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.

Applicants must have met the qualification requirements (including selective placement factors - if any) for this position by the closing date OR within 30 calendar days of the closing date to be eligible for this position.


There is no substitution of education for experience for this position. 

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. Time in grade (TIG) must be met within 30 days of the closing date of the announcement.

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 on the following competencies (knowledge, skills, abilities and other characteristics):

  1. Knowledge of biologics regulatory review process in order to identify information needs and to develop reports.
  2. Knowledge of legislation and regulations affecting biologics and FDA’s review process in order to identify and satisfy information reporting needs.
  3. Ability to evaluate the effectiveness of internet information system in order to determine the appropriate enhancement and/or improvements to the system.
  4. Ability to communicate orally in order to conduct training and give presentations on the Center’s information system.

Agency Career Transition Assistance Program (CTAP) or the Interagency Career Transition Assistance Program (ICTAP) Eligibles: If you have never worked for the Federal government, you are not CTAP/ICTAP eligible. Information about ICTAP or CTAP eligibility can be found at http://archive.opm.gov/ctap/index.asp to access OPM’s Career Transition Resources website. To be considered well qualified under CTAP/ ICTAP, you must be placed in the Well Qualified category for this position (achieving a score of at least 85). In addition, you must submit the supporting documents listed under the required documents section of this announcement.

Veterans: Certain veterans are eligible to apply as a status candidate under the Veterans Employment Opportunity Act (VEOA). Please submit copy 4 of your DD214 to substantiate claim.  For more information, please click http://www.fedshirevets.gov/job/shav/index.aspx

 


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

 

Interagency Career Transition Assistance Program (ICTAP):  For information on how to apply as an ICTAP eligible see http://opm.gov/rif/employee_guides/career_transition.asp#ictap.  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.



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 Tuesday, April 16, 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.

 

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: 868561.  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.
  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 Center HelpDesk Telephone (888)-478-4340; TTY/TDD: (866)-539-4484; or by email quickquestions@fda.hhs.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:

  4.      - Veterans Preference Documentation, if applicable

         - 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)

         - Individuals with Disabilities (must submit proof on the organization's letterhead), if applicable
                          For Sample letter: http://www.fda.gov/downloads/AboutFDA/WorkingatFDA/UCM276860.pdf.

 

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 Tuesday, April 16, 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-MP-13-868561

Control Number:

340867400