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

Job Title:Director, Office of Medical Products & Tobacco Operations

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-SL-2013-900687

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

The contents of the announcement can still be viewed.

SALARY RANGE:

$119,554.00 to $165,300.00 / Per Year

OPEN PERIOD:

Monday, July 22, 2013 to Monday, August 19, 2013

SERIES & GRADE:

SL-0696-00

POSITION INFORMATION:

Full Time - Permanent

DUTY LOCATIONS:

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

WHO MAY APPLY:

United States Citizens

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 Food and Drug Administration (FDA) is a Federal scientific law enforcement agency with the legislated responsibility for ensuring that drugs, biological products and medical devices are safe and effective, that food and drugs are adequately packaged and informatively labeled and that radiation emitting devices are safe, and to prevent and reduce tobacco use. The work of the FDA is carried out by thousands of personnel stationed throughout the United States and abroad. The staff includes physicians, scientists, engineers and a variety of other multidisciplinary professional, technical and support personnel. FDA’s programs are national in scope and international in effect, and its activities directly affect and heavily impact upon multi-billion dollar industries, in addition to protecting the public health of hundreds of millions of American consumers.

 

This is a Senior Level (SL) executive position is located in the Food and Drug Administration, Office of Global Regulatory Operations and Policy, Office of Regulatory Affairs, Office of Medical Products and Tobacco Operations in Silver Spring, MD.

 

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; and individuals with disabilities. YOU MUST SUBMIT YOUR SF-50 AND/OR DD FORM 214.

This position is located on the staff of the Assistant Commissioner for Operations in the Office of Regulatory Affairs (ORA). The ORA plans and directs the management and administration of personnel and facilities to ensure the federal laws and regulations regarding FDA regulated products are enforced. ORA directs nationwide field operations that are performed by several thousand scientific, professional, regulatory and consumer safety personnel geographically dispersed throughout the nation and abroad; and manages state-of-the-art scientific laboratories strategically located throughout the U.S. and Puerto Rico.

The Director, Office of Medical Products and Tobacco Operations, serves as the principal advisor to the Assistant Commissioner for Operations (ACO).  In addition, the incumbent serves as the supervisor of Division of Medical Products and Tobacco Program Operations and the Division of Medical Products and Tobacco Inspections.

 

 

KEY REQUIREMENTS

  • U.S. Citizenship is required.

DUTIES:

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As the Director, the incumbent performs substantive work and participates with the ACO by providing leadership and strategic advise in the development, implementation and evaluation of regulations and policies as they relate to ORA’s broad national and international programs and activities to ensure the safety, quality, efficacy, and labeling, in their specialized functional areas, such as FDA regulated human drugs, biologics, animal drugs, medical devices and tobacco products. 

a.    Represents and makes decisions on behalf of the ACO relative to medical products and tobacco programs investigatory operations, including emergency response activities.

b.    Represents and speaks for the ACRA in discussions, meetings, conferences, and consultations with top-level departmental and agency officials, national/international industry representatives, academic organizations and groups, foreign officials, members of Congress and/or their representatives, personnel from other executive departments and independent Federal agencies, State and local governmental counterparts and others to secure and provide information concerning critical and significant issues, actions and regulatory activities related to ORA programs and to resolve complex regulatory questions and issues that arise.

c.    Participates with the ACRA, senior officials and others in preparing for and/or testifying before Congress on agency regulatory programs and activities. As the focal point of information on ORA regulatory matters, provides authoritative advice, guidance, assistance, interpretations, and recommendations to key agency officials, programs directors, professional personnel, departmental representatives, intra/inter-governmental counterparts and others on problems related to Center regulated products. Furnishes expert advice and comments on matters related to existing programs and regulations and proposes new programs and regulations.

d.    Provides leadership and direction on the application of risk management and program evaluation techniques to regulatory compliance activities so that limited resources can provide the most public health promotion/protection at the least cost to the public. Works closely with Agency risk management and program evaluation experts, including those in ORA, the Centers and the Commissioner’s Office, to identify opportunities for enhanced coordination and better approaches to identifying, prioritizing, and managing risk through field compliance programs, and other approaches including 32 enhanced collaboration within FDA and counterpart governmental agencies, domestically and abroad, and other interested stakeholders. 


QUALIFICATIONS REQUIRED:

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MINIMUM QUALIFICATION REQUIREMENTS:
A determination of your minimum qualifications will be based on the requirements listed below. You will be evaluated based upon the experience and/or education reflected in your resume. Please use clear and concise descriptions/examples when describing your experience. Applicants are 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.

SPECIALIZED EXPERIENCE:
You must have at least fifty-two (52) weeks of previous experience that meets the level of difficulty and complexity of the GS-15 grade level in the Federal service, formulating and analyzing payment methodologies, evaluating legislation, policy and program issues, interpreting technical information, preparing briefing documents, serving as a representative for an organization, and serving as a project leader for assigned studies.


Applicant must possess a degree that included at least 30 semester hours in one or a combination of the following: biological sciences, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, or related scientific fields that provided knowledge directly related to computer safety officer work. The 30 semester hours can included up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming.

 

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: http://www.ed.gov/.

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 will be required.

6. One-year probationary period may be required.

7. Travel, transportation, and relocation expenses may be paid.

8. Bargaining Unit Position: No

9. Drug Screening Required: No

10. Recruitment Bonus may be authorized:  No

11. Time in grade (TIG) must be met by closing date of the announcement.

Once the application process is complete, a review of 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.

HOW YOU WILL BE EVALUATED:

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

1. Ability to provide leadership, strategic planning, advice and guidance.

2. Ability to coordinate and provide liaison responsibility.

3. Ability to provide direction and program oversight.

4. Skill in oral communication.

5. Skill in written communication.

 

 


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 **.0 or above on the rating criteria for this position.

Other Requirements

The Ethics in Government Act, PL 95-521 requires the applicant selected for this position to submit a financial disclosure statement, SF-278, prior to assuming the SES position, annually, and upon termination of employment.  Status applicants must submit a copy of their most recent SF-50, Notification of Personnel Action, which verifies status.

 

All applicants will be considered without regard to race, color, religion, national origin, marital status, political affiliation, age, sex, sexual orientation, disabling condition, membership in an employee organization, or any other non-merit factors.

 



HOW TO APPLY:

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To apply for this position, you must provide a complete Application Package which includes:

 

1. Your Résumé

2. A complete Assessment Questionnaire

3. Other supporting documents:

         - Veterans Preference Documentation, if applicable
              - College Transcripts, if applicable

         - Notification of Personnel Action (SF-50)


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.
 

The complete Application Package must be submitted by 11:59 PM (EST) on Monday, August 19, 2013.

 

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 900687.  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/pdfimage/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 Rockville Center HelpDesk Telephone (888)-478-4340; TTY/TDD:  Rockville/Bethesda Use (800) 877-8339; Baltimore Use (410) 786-0727, email quickquestions@psc.gov; please contact the Customer HelpDesk Telephone (770) 488-1725; TTY/TDD: Atlanta Use (866) 539-4484; email HRCS@TARGET.CDC.GOV. The decision on granting reasonable accommodation will be made on a case-by-case basis.


REQUIRED DOCUMENTS:

The following documents are required and must be received by the closing date of this announcement:

1. Your Resume'
2. A complete Assessment Questionnaire
3. Other supporting documents:
    - Veterans Preference Documentation, if applicable
    - College transcript, if applicable
    - Notification of Personnel Action (SF-50)

For Resume' and Application Tips visit:

http://www.usajobs.gov/ResourceCenter/Index/Interactive/TenTips#icc

AGENCY CONTACT INFO:

Kisha Hightower
Phone: (240)402-4350
TDD: 18008778339
Email: KISHA.HIGHTOWER@FDA.HHS.GOV
Agency Information:
HHS FDA Center Executive Resources
10903 New Hampshire Avenue
Silver Spring, MD
20993

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).  The Federal Government offers a comprehensive benefits package. Explore the major benefits offered to most Federal employees at
http://www.usajobs.gov/ei/benefits.asp#icc.

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Job Announcement Number:

HHS-FDA-SL-2013-900687

Control Number:

345089300