Food and Drug Administration Regulatory Health Project Coordinator/Manager, GS-0601-12/13 in Silver Spring, Maryland

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

Opened Friday 5/20/2016 (158 day(s) ago)

** Closes Friday 12/30/2016 (66 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 (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: Open to all United States Citizens.

This is an Open Continuous Announcement with a closing date of December 30, 2016. The initial cut-off date for referral is May 31, 2016 or receipt of the 100th application (whichever comes first). After this date, additional referral lists will be created as vacancies are available.

This announcement covers multiple positions with the Department of Health of Human Services (DHHS), Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), including the following CDER offices:

The Office of New Drugs (OND) provides regulatory oversight for investigational studies during drug development, makes decisions regarding marketing approval for new drugs, including decisions related to changes to already marketed products, and provides guidance to regulated industry on a wide variety of clinical, scientific and regulatory matters.

The Office of Translational Sciences (OTS) promotes innovation in drug regulatory review across CDER. OTS assures the validity of clinical trial design and analysis by developing and applying quantitative and statistical approaches in the regulatory review process.

The Office of Medical Policy Initiatives (OMPI) provides oversight and direction for new and ongoing policy initiatives in broad-based medical and clinical policy areas, including initiatives to improve the science and efficiency of clinical trials, promote clinical trial quality, and enhance patient labeling.

The Office of Pharmaceutical Quality (OPQ) provides oversight of product quality throughout the lifecycle of a drug product and assures that quality medicines are available to the American public.

The Office of Surveillance and Epidemiology (OSE) is responsible for monitoring the safety of drugs and therapeutic biologics used by the American people.

The Office of Generic Drugs (OGD) is responsible for the oversight and review of generic drug products. OGD is the leader in the science and regulation of generic medicines, enabling innovation in generic drug development, evaluation, and surveillance.

*************************************************************This vacancy is also being announced concurrently with vacancy announcement FDA-CDER-16-MP-1702754SS 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.*************************************************************************

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


As a *Regulatory Health Project Coordinator/Manager, GS-601-12/13 *you will perform the following duties:

  • Manage the drug review process for one or more classes of drugs.
  • Plan, focus and coordinate team activities within the Division.
  • Plan and organize the work of the review teams to accomplish a variety of concurred activities performed in several organizations.
  • Serve as the point of contact for all communications concerning applications in the assigned drug classes.
  • Co-lead multiple and concurrent scientific review teams, critical to the management, review and evaluation of drug applications regulated by CDER.
Travel Required
  • Not Required
Relocation Authorized
  • No
Job Requirements
Key Requirements
  • U.S. Citizenship is required.
  • One year probationary period may be required.
  • Transcript(s) required.

In order to qualify for Regulatory Health Project Coordinator/Manager GS-0601-12/13you must meet the following:

BASIC QUALIFICATIONS for *Regulatory Health Project Coordinator/Manager GS-0601-12/13*:

Applicants must have successfully completed a full four-year course of study at an accredited college or university leading to a bachelor's or higher degree that included a major study in an academic field related to the health sciences or allied sciences appropriate to the work of the position.


In addition to the basic qualification requirement described above, the following additional education and/or experience are required. Transcripts must be provided with your application for qualifications based on education. Your application or resume must clearly show that you possess the specialized experience requirements.

Specialized experience is defined as experience that is typically in or related to the work of the position to be filled and has equipped the applicant with the particular knowledge, skills, and abilities to successfully perform the duties of the position.

GS-12: Applicant must have one year of specialized experience equivalent to at least the GS-11 grade level in the Federal service.

Specialized experience is defined as experience serving as a project manager reviewing and evaluating regulatory requirements for the drug application process.

GS-13: Applicant must have one year of specialized experience equivalent to at least the GS-12 grade level in the Federal service.

Specialized experience is defined as experience coordinating or leading scientific projects in collaboration with regulatory staff and multidisciplinary, matrix designed teams, to include clinicians, chemists, biologists, toxicologists, pharmacologists, and/or statisticians, in the drug review process; and ensuring legal, regulatory and policy requirements/compliance associated with drug development.

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.

To receive consideration for this position, you must meet all qualification requirements by the closing date of the announcement.

If you are claiming education as any part of your qualifications for this 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.

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. Pre-employment physical required: No5. Drug testing required: No

  1. License required: No

  2. Mobility agreement required:* No*

  3. Moving expenses authorized: No

  4. Immunization required: No10.Relocation Incentive authorized:* No11. Recruitment Incentive authorized: *No

  5. A background investigation may be required.

  6. Student loan repayment incentive authorized: May be authorized14. Annual leave for non-federal service authorized: May be authorized

  7. Bargaining Unit Position: Yes

  8. All qualification requirements must be met by the closing of the announcement.

  9. Only experience gained by closing date announcement will be considered.

  10. May be subject to satisfactory completion of one year probationary.

  11. Promotion Potential: Yes. This position has promotion potentials to the GS-13.

Security Clearance

Q - Nonsensitive

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: 438625600

Job Announcement Number: FDA-CDER-16-DE-1702149SS