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

Job Title:Lead Consumer Safety Officer

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-CDER-MP-13-881468

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

The contents of the announcement can still be viewed.

SALARY RANGE:

$105,211.00 to $136,771.00 / Per Year

OPEN PERIOD:

Monday, April 29, 2013 to Monday, May 13, 2013

SERIES & GRADE:

GS-0696-14

POSITION INFORMATION:

Full Time - Permanent

PROMOTION POTENTIAL:

14

DUTY LOCATIONS:

Few vacancies in the following location:
Silver Spring, MD United StatesView Map

WHO MAY APPLY:

FDA Employees within CDER Office of Compliance Only

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.

Who May Apply:  This vacancy is open to current Food and Drug Administration (FDA) employees within the Office of Compliance with competitive status only.  Competitive status refers to employees who are serving on a career or career conditional appointment.. 

PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to the Office of Compliance.  Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.

YOU MUST SUBMIT YOUR SF-50 (AND DD-214 IF APPLICABLE).

This position is located in Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Drug Security, Integrity, and Recalls (ODSIR) in Silver Spring, MD.

This announcement may be used to fill multiple positions in multiple locations.

KEY REQUIREMENTS

  • U.S. Citizenship is required.
  • FDA Office of Compliance Employees Only.
  • Some Domestic Travel is required.

DUTIES:

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Major Duties:

Serves as the technical scientific authority in areas including but not limited to case management, guidance and policy development, international agreements, compliance evaluations, data integrity, post-marketing, and risk evaluation and mitigation strategies;

Utilizes strategic thinking and decision making to develop and refine program priorities and goals;  

Ensures ongoing and appropriated communication with key Agency customers in the area of assigned responsibility; 

Facilitates resolutions of difficult regulatory issues via rigorous scientific inquiry and interactions with internal and external constituents, including industry organizations and other Agency components; 

Conceives of the mission for groups, independently develops propositions for study and speaks for the Division and the Office on matters in the area of regulatory responsibility;

 

Leads in the establishment of a consensus with FDA scientific, technical and medical personnel to establish precedence for compliance action or identify and recommend FDA position when policy is nonexistent or inapplicable;

  

Collaborates and cooperates on developing briefings, seminars, workshops and other outreach communication efforts on scientific risk-based compliance initiatives to achieve consensus; plans, and develops, prepares, coordinates and provides regulatory, educational and instructional information for internal and external uses;

 

Represents the Agency at meetings and conferences in his or her area of scientific expertise and deals with controversial issues or regulatory policies; and provides the Agency's view on important matters to gain consensus on regulatory positions and issues; 

 

Independently plans, designs, and carries out case policy review assignments and research projects to completion;  

 

Develops scientific guidelines, Agency policy, and programs which may involve complex and high priority matters affecting the regulation of drugs.

 

 


QUALIFICATIONS REQUIRED:

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Qualifications:

For the GS-14 grade level, applicants must have 52 weeks of specialized experience equivalent to the GS-13 grade level in the Federal service.  

Specialized Experience: Experience that 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. To be creditable, specialized experience must have been equivalent to at least the next lower grade level in the normal line of progression for the occupation in the organization.  

Specialized experience is required for this position: Experience in familiarity with administrative policies, procedures, regulations; strategic initiatives and programs, principles and practices of the Agency necessary to serve as an expert in improving Office wide program effectiveness and function. 

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.


*This position has a positive education requirement*  

BASIC EDUCATION REQUIREMENTS:

To meet the basic educational requirements, applicants must have completed either:

 

A)   Applicants must have 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 consumer safety officer work.   The 30 semester hours may 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

 

B)   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.

 

The quality of the combination of education and experience must have been sufficient to demonstrate that the applicant possesses the knowledge, skills, and abilities required to perform work in the

occupation, and is comparable to that normally acquired through the successful completion of a full 4 year course of study with major study in the appropriate field.

 

This position has a minimum education requirement; therefore, all federal employees who are changing occupation/series must submit either a list of courses or college transcript documenting relevant

college courses and credits to be considered for this position. This position has positive education requirements so applicants must submit college transcripts or list of courses, including title, credit hours and grade for each course if you are a federal employee changing series, or if you are an outside candidate.

 

- Qualifying education gained at colleges and universities in foreign countries must be evaluated in terms of its equivalency to that acquired at American colleges and universities.   Applicants educated in whole or in part in foreign countries must submit sufficient evidence, including transcripts, to an accredited private

organization for an equivalency evaluation.   A letter containing the results MUST accompany the application package.

 

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. 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.

HOW YOU WILL BE EVALUATED:

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):

Knowledge of the Food, Drug, & Cosmetic Act and enforcement policies and procedures;  

Knowledge and skill in planning, organizing, and directing programs;

Ability to communicate scientific oral information clearly and concisely;  

Ability to communicate scientific written information clearly and concisely;  


 


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.

 

Career Transition Assistance Program (CTAP):  For information on how to apply as a CTAP eligible see http://opm.gov/rif/employee_guides/career_transition.asp#ctap.  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.



HOW TO APPLY:

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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:  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 881468.  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/pdf_fill/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 Bethesda Center HelpDesk Telephone (888)-478-4340; TTY/TDD: (866)-539-4484; or by email quickquestions@psc.gov.  The decision on granting reasonable accommodation will be made on a case-by-case basis.


REQUIRED DOCUMENTS:

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

 

The complete Application Package must be submitted by 11:59 PM (EST) on Monday, May 13, 2013.

AGENCY CONTACT INFO:

FDA Helpdesk
Phone: (888)478-4340
Fax: (478)757-3144
Email: QUICKQUESTIONS@PSC.GOV
Agency Information:
HHS FDA Center
10903 New Hampshire Avenue
Silver Spring, MD
20993 Fax: (478)757-3144

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).


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Job Announcement Number:

HHS-FDA-CDER-MP-13-881468

Control Number:

342386100