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This Position Is No Longer Available

Job Title:  Staff Specialist GS-301-11/12
Department:  Department Of Health And Human Services
Agency:  Food and Drug Administration
Job Announcement Number:  HHS-FDA-ORA-MP-12-7226142

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

The contents of the announcement can still be viewed.
$62,467.00 to $97,333.00 / Per Year
Tuesday, August 13, 2013 to Friday, September 13, 2013
Full Time - Permanent
1 vacancy in the following location:
Rockville, MD United StatesView Map


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 eligible or who have been separated under honorable conditions after 3 years or more of continuous active service; Military Spouses; PHS Commissioned Corps Officer; individuals eligible for VRA appointments (at the GS-11 and below grade levels); and individuals with disabilities.


Current Federal employees who are PHS 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 (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.




This position is located in the Food and Drug Administration, Office of Regulatory Affairs, Office of Resource Management, Immediate Office in Rockville, Maryland.


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.



Salary range listed does include locality pay.


This announcement may be used to fill multiple positions.


  • U.S. Citizenship is required.
  • You must meet time-in-grade requirement within 30 days of the closing date.
  • Please carefully read and follow the instructions for HOW TO APPLY.


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This position is located in the Office of Regulatory Affairs (ORA).  The incumbent will serve as a Staff Specialist and personal advisor to the Director of the Office of Resource Management, ORA. He/she performs a wide range of difficult and confidential administrative duties.  Directs the staff administrative functions of the office described in the FDA Staff Manual Guides.


The incumbent of this position is responsible for ensuring that the operations of the Office Director is accomplished effectively and efficiently.  He/she relieves the Office Director of time consuming involvement in the management and coordination of special projects, particularly those projects which would otherwise necessitate their personal time and attention because of the highly complex technical, regulatory, or controversial nature of the issues involved.  Plans and conducts management analysis on internal and external procedures, identifies and efficiently oversees timely completion of work assignments received in the Immediate Office of the Director.  Coordination with other FDA offices, other PHS and HHS agencies, international organizations and regulatory professional organizations is assured through the incumbent's personal knowledge of the substantive nature of the work to be performed and the activities of the different organizations.


Actively interacts with the Office Director and his/her Deputy, and other senior FDA staff.  Keeping abreast of ORA program activities and other agencies within the Federal government, international organizations and regulatory professional organizations.  Through review of documents detailing the Office's significant activities, and other pertinent documents, keeps the Office Director and other key personnel apprised of Office activities, pending policy matters, and implications of current activities for the Office.  this requires the incumbent to knowledge ably discern important issues, set priorities, and apprise appropriate member of the Office Director's staff of the circumstances which might alter or complicate issues requiring action by the Office Director.  Action in this regard involves direct and tactful contact with the Office Staff.


Interpret and analyzes decisions to differentiate among priorities of the utmost importance the Office Director and his/her Deputy.  understand the political awareness of issues as they relate to the on-going work of the Office.


Works closely with key officials within ORA and offices within the Center as well as serving as the liaison regarding clarification and dissemination of instructions and information.


Attends meetings that the Office Director has with each staff, as necessary, as well as meetings with outside organizations on a broad range of issues.  Keeps abreast of the issues affecting Office activities.  Collects and analyzes information pertaining to significant ORA activities and provides it to the Office director and other Key staff to assist in appropriate decision making.


Researches and/or provides the Office Director with a wide range of material and information such as pending legislation, budget, new programs, etc.  to help him/her obtain a comprehensive view of problems and operations, and to understand the relationship and the long range impact of present decisions.  Searches and /or reports specific information on ORA functions and activities that is required by the Director in making reports or are required by her/him for use in high level meetings. 




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For the GS-11 grade level, applicants must have one year of specialized experience equivalent to the next lower grade level at the GS-09 in the Federal Service.


For the GS-12 grade level, applicants must have one year of specialized experience equivalent to the next lower grade level at the GS-11 in the Federal Service.


Specialized experience is experience that has equipped the applicant with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled, and can be demonstrated through skill with planning, scheduling, and conducting projects and studies to evaluate, identify and resolve issues and problems.



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.

Ph.D. or equivalent doctoral degree


3 full years of progressively higher level graduate education leading to such a degree


LL.M., if related




Foreign Education:  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; or full credit has been given for the courses at a U.S. accredited college or university.  For further information, visit:

Conditions of Employment:


1. Additional Security and Background Requirements:  May be referred depending on the position being filled.  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. All qualification requirements must be met by the closing date of the announcement.


3. Financial disclosure statement may be required.


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


5. Bargaining Unit Position: No


6. Drug Screening Required: No


7. Recruitment Bonus may be authorized: No


8. Research position: No


9. Supervisory position: No


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


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. Knowledge of a wide range of analytical methods and techniques for planning, conducting, analyzing, and evaluating the effectiveness of programs and a abroad, general knowledge of related studies and cases.


2. Knowledge of pertinent laws, regulations, policies and precedents which affect the Office, the effectiveness and efficiency of the organization.


3. Skill in oral communications.


4. Skill in written communications.


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


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 Assistance Program (CTAP):  For information on how to apply as a CTAP eligible see  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.


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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:


To fax supporting documents you are unable to upload, complete this cover page using the following Vacancy ID 726142.  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 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  The decision on granting reasonable accommodation will be made on a case-by-case basis.


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.      - 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:


The complete Application Package must be submitted by 11:59 PM (EST) on Tuesday, August 12, 2014.


Bethesda Center Helpdesk
Phone: (888)478-4340
Fax: (478)757-3144
Agency Information:
OHR Bethesda Operations Center
7700 Wisconsin Ave
Bethesda, MD
20814 Fax: (478)757-3144


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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