Food and Drug Administration Regulatory Health Information Specialist in Silver Spring, Maryland

Food and Drug Administration
Many vacancies in the following location:
  • Silver Spring, MD
Work Schedule is Full Time - Permanent

Opened Thursday 10/13/2016 (7 day(s) ago)

** Closes Wednesday 10/26/2016 (6 day(s) away)

Job Overview

Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (DHHS) 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 Center for Tobacco Products (CTP) of the Food and Drug Administration (FDA) is responsible for implementing the Family Smoking Prevention and Tobacco Control Act. This law gives FDA authority over tobacco products by adding a new chapter to the Food, Drug and Cosmetic Act. The Tobacco Control Act gives FDA the authority to regulate tobacco products and manufacturers based on the best available science and CTP is responsible for both assessing and fostering that science-base. CTP's actions have significant public health and consumer protection impact, and are among the most important issues faced by the Agency in its long and distinguished history.

This position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Centers for Tobacco Products (CTP), Office of Science (OS), Silver Spring, MD.

This vacancy is also being announced concurrently with vacancy announcement FDA-CTP-17-MP-1823892CHunder 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.

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

  • Serve as project leader and manager of the regulatory health information systems that support CTP's scientific review programs and activities.
  • Organize and maintain information or information management systems.
  • Prepare periodic and special reports pertaining to product review status and other matters related to various scientific and regulatory review and research activities handled by the office.
  • Provide technical advice on exchanging information regarding the design, development, and utilization of information management systems in support of regulatory review.
  • Provide training to a variety of users, reviewers, and managers on how to use the system, types of information available, and reporting capabilities.
Travel Required
  • Occasional Travel
  • Domestic travel is required approximately 2% of the time.
Relocation Authorized
  • No
Job Requirements
Key Requirements
  • U.S. Citizenship is required.
  • Only experience gained by closing date announcement will be considered.
  • One year probationary period may be required.


*Basic Qualification Requirements for GS-0601, Regulatory Health Information Specialist: *

All applicants must complete a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree with major study in an academic field related to the health sciences or allied sciences appropriate to the work of the position.

You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. 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. For further information, click on foreign education.

Specialized Exprience:

In addition to meeting the Basic Qualification Requirement you must also meet the following:

GS-12: All applicants must have one year of specialized experience, equivalent to the GS-11 level in the Federal service, to include performing quality assurance checks on scientific or regulatory data and maintaining regulatory and scientific data management information systems.

GS-13: Have one year of specialized experience, equivalent to the GS-12 level in the Federal service, to include providing guidance in analysis of regulatory and health information/data pertaining to scientific review programs and activities.

Conditions of Employment:

Security and Background Requirements: 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. 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 disciplinary action. 2. E-Verify: If you are selected for this position, the documentation you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the 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. Pre-employment physical required:* No* 5. Drug testing required: No 6. License required: No 7. Mobility agreement required: No 8. Immunization required: No 9. A background investigation may be required. 10. Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc. 11. Bargaining Unit Position: Yes 12. Please be advised that this position will be subject to FDA's strict prohibited financial interest regulation and therefore, may require the incumbent of this position to divest of certain financial interests. Applicants are strongly advised to seek additional information on this requirement from the FDA hiring official before accepting this position.

Security Clearance

Public Trust - Background Investigation

Additional Information
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.


The Federal Government offers a comprehensive benefits package. Explore the major benefits offered to most Federal employees at

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 (Member 4 copy) 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

Males born after December 31, 1959 must be registered or exempt from Selective Service (see

For information on "People with Disabilities" please visit

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:

Salary Range: $77,490.00 to $119,794.00 / Per Year

Series & Grade: GS-0601-12/13

Promotion Potential: 13

Supervisory Status: No

Who May Apply: United States Citizens

Control Number: 452918000

Job Announcement Number: FDA-CTP-DE-17-1819640CH