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 and Tobacco Operations

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-AD-13-889431

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

The contents of the announcement can still be viewed.

SALARY RANGE:

$123,753.00 to $199,700.00 / Per Year

OPEN PERIOD:

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

SERIES & GRADE:

AD-0696-00

POSITION INFORMATION:

Full Time - Excepted Service Permanent

DUTY LOCATIONS:

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

WHO MAY APPLY:

All groups of qualified individuals

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.  Join HHS and help to make our world healthier, safer and better for all Americans.

This position reports to the Assistant Commissioner for Field Operations (ACO), Office of Operations (OO), Office of Regulatory Affairs (ORA), Office of Global Regulatory Operations and Policy (OGROP), within the Food and Drug Administration (FDA) in Rockville, Maryland. ORA is the lead office for all field activities at the FDA.  Regulating more than 135,000 business establishments that annually produce, warehouse, import and transport $1 trillion worth of consumer goods, ORA protects consumers by maximizing compliance of FDA regulated products and minimizing risk associated with these products.  More than 4,000 ORA personnel in more than 200 locations work every day to minimize public health risk.

Executive level compensation package is commensurate with qualifications and experience, which may result in a higher salary than reflected above.

Applications will be accepted from all groups of qualified persons, including non-citizens and Public Health Service Commissioned Officers.  No previous federal experience is required.  This is an Excepted Service position under Title 42.  This appointment does not confer any entitlement to a position in the competitive service and no entitlement to Merit Systems Protection Board (MSPB) appeal rights.

KEY REQUIREMENTS

  • Background and/or Security Investigation required.

DUTIES:

Back to top

The incumbent serves as the Director, Office of Medical Products and Tobacco Operations in the Office of Operations (OO) for the Office of Regulatory Affairs (ORA) in the Office of Global Regulatory Operations and Policy (OGROP).  As the Director, the incumbent serves as the Senior Medical Products and Tobacco Operations Officer, who will be a key member of the senior management team of the Associate Commissioner for Regulatory Affairs (ACRA) and Assistant Commissioner for Operations (ACO), which has responsibilities for decision making processes and leads discussions and decision-making concerning ORA plans, programs, and activities, both during strategic planning sessions and in the actual determination, allocation, and administration of ORA program segment(s), functions, and activities.

The incumbent provides expert advice and counsel concerning approaches and options that are sound and feasible in relation to ORA's regulatory goals and objectives. As the Senior Medical Products and Tobacco Operations Officer, the incumbent serves as the principal advisor to the ACO and ACRA and is recognized as the person who can speak authoritatively for the ACO and ACRA on matters pertaining to the OMPTO programs.

The incumbent represents the Agency, the ACRA and/or the ACO in meetings, conferences, and committees involving policy and other matters pertinent to the Office of Medical Products and Tobacco Operations programs; provides input from the ACRA concerning critical and significant issues and regulatory activities to resolve regulatory questions and issues relating to medical and tobacco products; and coordinates with FDA Centers, ORA Headquarters (HQ) components, ORA Regional and District Offices, other Federal agencies, international and state and local governments concerning the interpretation of regulatory requirements, impacts, and other issues.

The incumbent represents the ACRA and/or the ACO in dealing and negotiating with representatives of Congress; HHS Operating Divisions, other federal agencies; state, local, and, at times, foreign governments; the regulated industry; professional and industry organizations; and public interest groups and provides authoritative counsel and guidance concerning critical and significant regulatory questions and issues related to medical and tobacco products.

Oversees the implementation of new laws and regulations, which impact the mission of ORA and OMPTO.  This includes responsibility for the initiation and implementation of new policies, systems, and procedures.

The incumbent is responsible for analysis of the impact of proposed changes to Agency laws and regulations, policies, and procedures, which affect the functions, program segment(s), and activities of ORA's HQ and field offices that are involved with FDA's/ORA's nationwide regulatory and compliance operations as they relate to medical products (e.g., drugs, biologics and devices) and tobacco program operations.  Identifies changes and additions to the functions, program segment(s), and activities of ORA necessary to implement new legislation or regulations, and develops various scenarios for dealing with expansion or contraction of ORA functions, program segment(s), and activities in relation to investigational and regulatory efforts in the medical products and tobacco operations programs.

The incumbent oversees, monitors and evaluates and provides guidance on the effectiveness of Regional and District Office investigational, regulatory and compliance activities related to food and feed program operations.  Provides guidance on matters which cannot be resolved at the local level and coordinates efforts among the various offices.

 


QUALIFICATIONS REQUIRED:

Back to top

Basic Qualifications

Basic Qualifications for AD-0696 (Consumer Safety Officer):  Applicants must possess a degree that includes 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 consumer safety officer work. The 30 semester hours can include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming OR combination of education and experience -- courses consisting of at least 30 semester hours in the fields of study described above, plus appropriate experience or additional education.

In addition, applicants must possess a Ph. D. or other earned doctorate in a scientific field related to the position to be filled.

Mandatory Technical Qualifications

In addition to specialized experience, applicants must possess the following technical qualifications that represent the knowledge, skills, and abilities essential to perform the duties and responsibilities of the position:

1.   Senior level experience as a leader in a complex organization in planning, directing, and evaluating multidisciplinary activities of significant scope and effect.

2.   Demonstrated ability to build strong working relationships among people and organizations with diverse interest and/or opinions, including regulated industry, professional or public health, advocacy consumer organizations, other Federal, State or local agencies, foreign governments, and the Congress.

3.   Ability to supervise a professional staff engaged in providing policy advice to senior officials.

Desirable Qualifications

It is desired that you have:

1.   Training, professional development, and outside professional activities that provide evidence of initiative, resourcefulness and potential for effective job performance at a senior level and honors, awards, or other recognition for performance or contributions related to the position.


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 evaluation 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/.

Candidates must show clear evidence of specialized experience.  Specialized experience is that which is directly related to the position and which has equipped the applicant with the particular knowledge, skills, and abilities (KSAs) to successfully perform the duties of the position to include senior level experience in consumer safety.

.

 

HOW YOU WILL BE EVALUATED:

Applicants must meet the qualification requirements as outlined above to be eligible for further consideration.  You must provide detailed evidence of the experience, knowledge, skill, ability, and other personal characteristic requirements and show how and when they were used.  This evidence must include clear, concise examples that show level of accomplishment and degree of responsibility.  Qualification determinations will be based on the information provided in your application and the requirements of the position.  Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics).

 

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 may be paid.

8. Bargaining Unit Position: No

9. Drug Screening Required: Yes

10. Recruitment or Relocation Incentive may be authorized: May Be Authorized.


BENEFITS:

Back to top

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:

Other Information

Males born after December 31, 1959 must be registered or exempt from Selective Service (see http://www.sss.gov).

Drug Free Workplace

The incumbent of this position will be subject to testing for drug usage in accordance with the HHS plan for a Drug Free Workplace.

This position within FDA is subject to strict restrictions on financial holdings (FDA regulated financial holdings).  Applicants are advised to seek additional information from the Ethics Staff prior to accepting such a position.  Please refer to the following website:

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofOperations/OfficeofManagement/ucm197884.htm

 



HOW TO APPLY:

Back to top
To apply for this position, you must provide a complete Application Package, which includes ALL of the documents listed in the Required Documents section of this vacancy announcement.  Any documents submitted that are not listed in the Required Documents section of this announcement will not be considered or forwarded to the rating panel or selecting official.

Application packages for this vacancy must be received on-line via the USA Staffing web site 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.  You may preview the assessment questionnaire by clicking here:  View Occupational 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 Identification Number:  889431.  Fax your documents to 1-478-757-3144.

Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful.

If applying online poses a hardship to you, please contact the Human Resources Operations Center HelpDesk Telephone (888)478-4340, TTY/TTD (800)877-8339; or email quickquestions@psc.gov.  You must contact the Human Resources Operations Center HelpDesk prior to the closing date of this announcement to receive assistance.  The decision on granting reasonable accommodation will be made on a case-by-case basis.  Hours of operation:  Monday through Friday 7:30AM to 4:00PM EST.



REQUIRED DOCUMENTS:

1.  Your Resume

2.  Completion of online Questionnaire; 

3.  Other supporting documents:

     -   College Transcripts, foreign education evaluation, SF-50 (if prior federal service)

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.

The complete Application Package must be submitted by 11:59 PM (EST) on the closing date.

AGENCY CONTACT INFO:

Glenda D. Miller
Phone: (301)492-4653
Email: GLENDA.MILLER@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.  When the vacancy announcement closes, an evaluation of your qualifications will be determined by a panel of experts.  The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview.

Once this process is completed (generally 4-6 weeks), you will receive notice via email.  If no email address was provided by you during the application process, notice will come via US mail.


Back to top
Dock
Print Preview

Job Announcement Number:

HHS-FDA-AD-13-889431

Control Number:

343527500