Supervisory Consumer Safety Officer Job in SILVER SPRING, MD

Vacancy No.

HHS-FDA-09-2008-0250

Department

Health & Human Services, Food and Drug Administration (FDA)

Salary

$98,033.00 to $127,442.00

Grade

14 to 14

Perm/Temp

Permanent

FT/PT

Full-time

Open Date

8/15/2008

Close Date

8/21/2008

Job Link

Apply Online

Who may apply

Status Candidates

Locations:

SILVER SPRING, MD

 

 

 

 

Job Description (Please follow all instructions carefully)


Department: Department Of Health And Human Services
Agency: Food and Drug Administration
Sub Agency: Department of Health and Human Services
Job Announcement Number:
HHS-FDA-09-2008-0250


Supervisory Consumer Safety Officer
Salary Range: 98,033.00 - 127,442.00 USD per year
Open Period: Friday, August 15, 2008
to Thursday, August 21, 2008
Series & Grade: GS-0696-14/14
Position Information: Full Time Permanent
Promotion Potential: NA
Duty Locations: few vacancies - Silver Spring, MD
Who May Be Considered:

This position is open to CDER Wide Only

 

Additional selections may be made.  The vacancy may be shared with

other organizations.

 

Position Details:

Tenure: Career Conditional Appointment

Bargaining Unit Position: No

Merit Promotion Position: Yes              

Recruitment Bonus: No

Relocation Paid: No

 

Salary range listed includes locality pay


Job Summary:

Become a part of the Department that touches the lives of every

American! At the Department of Health and Human Services 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 is located in Department of Health and Human Services,

Food and Drug Administration, Center for Drug Evaluation and

Research, Office of New Drugs, Office of Antimicrobial Products,

Division of Antiviral Products in Silver Spring, Maryland.


Key Requirements:

  • US Citizenship
  • Travel Required: No



Major Duties:

Provides supervisory leadership and direction so that the Division

is provided the types and quality of support and services needed for

effective operations.  These include the assignment of work; setting

of priorities and coordinating work scheduling in conjunction with

other division supervisors and management staff.

 

Participates in the development and implementation of policy and

strategy to the regulation of whole classes of drugs as well as

individual drug applications and related drug regulatory matters and

in the improvement of the various review and regulation process.

 

Assists division management in the coordination and management of

the various work demands with the objective of assuring their timely

and efficient completion.

 

Coordinates with document room (DDR) contract staff.  Oversees

productivity and performance of DDR.  Monitors processing and

timeliness procedures for processing incoming and outgoing

documents.  Consults with contract management staff regarding

quality control.

 

Provides expert consultation and other forms of staff assistance to

division medical and scientific staff on issues involving the

application of the Food, Drug, and Cosmetic (FD&C) Act, its

implementing regulations and other statutes relating to the

regulation of new drugs.

 

Provides policy guidance to assigned staff, identifies goals and

establishes priorities to assure overall coordination of the

completion of applications on a timely basis.  Assures that

applications are coordinated throughout the Division by continuous

control and monitoring from initial receipt to completion.

 

Serves in a leadership role with respect to identification of key

policy issues, resolution of problem situations, and initiates and

implements necessary actions.  Communicates with Office and Center

management on policy issues and problems to establish needed

coordination and suggests means for their resolution.

 

Directs the legal, regulatory, administrative and general overall

review of a variety of submissions after the medical and scientific

reviews and prior to final endorsement by the Division Director.

 

Serves as a source of definitive advice/information on the

application of the Food, Drug, and Cosmetic Act and its implementing

regulations regarding new drugs and provides advice on policies and

strategies to division staff.

 

Conducts special studies and investigations related to issues that

arise on specific applications.

 

Serves as focal point in the Division for requests from the HHS

General Counsel's office to assure that the scientific facts are

transmitted in the appropriate form and are responsive to their

needs.  Personally drafts statements, interpretations, new

regulations and proposed changes for Federal Register publication,

position papers, etc.

 

Represents the Division in meetings with industry, other government

agencies, and others to provide information on the policy, law and

regulations on the drug classes in the Division.



Qualifications:

Foreign Degree Note: All foreign degrees must be evaluated by a

nationally recognized Accrediting Agency and must submit proof of

such evaluation and/or conversion within 48 hours upon request

 

ALL QUALIFICATION REQUIREMENTS MUST BE MET NO LATER THAN THE CLOSING

DATE OF THE VACANCY ANNOUNCEMENT.  THIS INCLUDES TIME IN GRADE

REQUIREMENTS FOR CURRENT STATUS EMPLOYEES APPLYING THROUGH MERIT

PROMOTION PROCEDURES.

 

Applicants must demonstrate one year of specialized experience

equivalent to that of the next lower grade level in the Federal

Service.

 

For the GS-14 grade level, applicants must have one year of

specialized experience equivalent to a GS-13 level, 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 experience related to the laws and regulations

protecting consumers from products in violation of the Food, Drug,

and Cosmetic (FD&C) Act and related regulatory policy and experience

in performing varied and broad activities in the nonprescription

drug application review process.

Basic Requirements:

 

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 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 in A above,

plus appropriate experience or additional education.

 

All qualifications and eligibility requirements, for the position

must be met by the closing date of this vacancy announcement. If

this is your first supervisory position, YOU WILL BE REQUIRED TO

SERVE A ONE YEAR PROBATIONARY PERIOD UPON SELECTION.


How You Will Be Evaluated:

Your resume and responses to the self-assessment job questions are

an integral part of the process for determining your basic and

specialized qualifications for the position.  Therefore, it is

important to support your responses to the applicant assessment

questions by providing examples of past and present experience

when requested.

 

There are several parts of the application process that affect the

overall evaluation of your application:

 

1.                Your resume which is part of your USAJOBS profile

2.                Your responses to the core questions

3.                Your responses to the self-assessment job-specific questions

4.                Your supporting documents

 

 

High self-assessment in the vacancy questions that is not supported

by information in your resume, essay responses, and/or supporting

documents may eliminate you from best-qualified status or result in

a lowered score.

 

Additional details on the application process can be found at

the "How to Apply" section  of this announcement.

 

Please be sure to allow yourself adequate time to apply for this

vacancy. We recommend that you preview the questions for this

announcement before you start the application process using the

"click here" link below.

To preview questions please click here.

Benefits:

You may participate in the Federal Employees Health Benefits

program, with costs shared with your employer.

More Info

 

Life insurance coverage is provided.More Info

 

Long-Term Care Insurance is offered and carries into your

retirement.More Info

 

New employees are automatically covered by the Federal Employees

Retirement System (FERS). If you are transferring from another

agency and covered by CSRS, you may continue in this program. More Info

 

 

You will earn annual vacation leave.More Info

 

You will earn sick leave.More Info

 

You will be paid for Federal holidays that fall within your

regularly scheduled tour of duty.Mor Info

 

Alternative work schedule options are available.

 

If you use public transportation, part of your transportation costs

may be subsidized. Our human resources office can provide additional

information on how this program is run.


Other Information:

(Status applicants) persons who have a career or career-conditional

appointment in the Competitive service or have reinstatement

eligibility or who are currently in the Commissioned Corps, are

eligible to apply.) Veterans' Employment Opportunities Act --

Preference eligibles or veterans who have been separated from

the armed forces under honorable conditions after substantially

completing 3 or more years of continuous active service may apply.

 

Veterans Employment Opportunities Act of 1998 (VEOA)

 

This flexibility gives eligible veterans access to jobs that

otherwise only would have been available to status employees. In

VEOA

appointments, veterans are not accorded preference as a factor, but

they are allowed to compete for job opportunities that are not

offered to other external candidates. A VEOA eligible who is

selected

will be given a career or career-conditional appointment.

 

Who is eligible:

VEOA eligibility applies to the following categories of veterans:

1. Preference eligibles; and

 

2. Service personnel separated after 3 or more years of continuous

active service performed under honorable conditions

 

 

ALL APPLICANTS ARE CONSIDERED WITHOUT REGARD TO RACE, RELIGION,

COLOR, NATIONAL ORIGIN, SEX, SEXUAL ORIENTATION, POLITICAL

AFFILIATION, AGE (WITH AUTHORIZED EXCEPTIONS) OR ANY OTHER NON-MERIT

FACTOR.

 

CONDITIONS OF EMPLOYMENT: 

 

Certain positions within the FDA are subject to strict restrictions

on financial holdings (FDA regulated financial holdings).  To

determine whether this position is affected, applicants are advised

to seek additional information during the interview process from the

Ethics and Integrity Staff, Office of Management Programs, Office of

Management at (301) 827-5511 prior to accepting such a position.

 

 

Background Investigation:

 

If selected for this position, you may be subject to a background

investigation.

 

More Employment Information:

1. Veterans Information

 

2. Former Federal employee reinstatement eligibility

 

3. Department of Health and Human Services (DHHS) Surplus or displaced
Employees
CTAP criteria.

 

4. Displaced Federal employees ICTAP criteria.



How To Apply:

Please read the ENTIRE vacancy announcement to ensure that you

comply with the application procedures.  Your application will be

regarded as incomplete and will not be considered, if the Rockville

Human Resources Center (RHRC) does not receive your application and

all required supplemental documentation, as specified in

the "Supporting documents" section of this vacancy announcement, by

11:59 PM Eastern Standard Time (EST) on the closing date of this

vacancy announcement.

 

Your application and all required supplemental documents must be

submitted in the manner specified in this section.  Applications and

supplemental documents that are submitted in any other manner

without prior approval from the agency point of contact will be

handled as incomplete and will not be considered.

 

You must complete the following three steps described below in order

to apply for this position online.

 

STEP ONE - (Online Resume - USAJOBS)

 

You must create a user account and at least one Federal resume at

USAJOBS. Information you provide in USAJOBS is general information

completed by all applicants. The information you provide and your

Federal resume will become part of your application and will

automatically be transferred to the HHS Careers system when you

apply on-line.  After you finish submitting your resume from

USAJOBS, you will automatically be taken to HHS Careers where you

will be asked to complete the next step of the application process. 

You may edit your resume up until 11:59 PM EST of the announcement

close date.

 

STEP TWO - (Vacancy Specific Questions - HHS Careers)

 

In HHS Careers, you will answer vacancy specific questions necessary

to evaluate your qualifications for the specific job to which you

are applying. When completed, the information you provided at

USAJOBS and the answers to the HHS Careers questions will become

your application. You may edit your answers by 11:59 PM EST of the

announcement close date.  

 

STEP THREE - (Submit Supporting Documents - HHS Careers)

 

After you have completed the vacancy specific question and selected

the "FINISH" button, a list of fax cover sheets will appear with

instructions.  A complete listing of the material that must be

submitted to the HR office is provided in the "Supporting Documents"

section of this announcement.  Review this section for which

documents are applicable to you and how to submit.  Most of these

documents will be requested upon completion of the Vacancy

Questionnaire.  All applicable supplemental application material

must be received at the appropriate fax number, shown on the fax

cover sheet, by 11:59 Eastern Time on the closing date.  Failure to

submit these documents will eliminate your from consideration.

 

 

 

For additional Information:

Rockville Center HelpDesk

Telephone 888-478-4340

quickquestions@psc.gov

Hours of operation: Monday through Friday 7:30AM to 5:00PM EST

TTY/TDD 800-877-8339

 

Reasonable Accommodation:

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 (800)-877-8339;

email quickquestions@psc.gov. The decision on granting reasonable

accommodation will be made on a case-by-case basis.

 

If applying online poses a hardship to you, the Rockville Center

HelpDesk listed on the announcement will provide assistance to

ensure that applications are submitted online by the closing date. 

You must contact the Rockville Center HelpDesk prior to the closing

date of this announcement to receive assistance.  Hours of

operation: Monday through Friday 7:30AM to 5:00PM EST


Required Documents:

Supporting Documentation

Your application will be considered INCOMPLETE and WILL NOT be

considered if you do not FAX all required supporting documentation

by 11:59 PM EST on the closing date of this vacancy announcement.

Our Fax number is 571-258-4052.

 

During the online application process, you will encounter a webpage

which lists the available fax coversheets. There will be several

options available.  However, you only need to print and submit the

fax coversheets that are applicable to you as an applicant.  You

must submit a coversheet for each type of supporting documentation.

Only the fax coversheet will ensure the proper receipt of your

materials(s) and the coversheet MUST be page one (1) of the

corresponding supporting documents.  All supporting documents must

be faxed before 11:59 PM EST on the closing date of the vacancy. You

will receive an email confirming receipt of your faxed supporting

documents within 24 hours. 

 

PLEASE NOTE:  Not all of the document types listed will pertain to

you; only submit documents needed to complete your application

package.  For example, the Schedule A Certification document must

only be submitted by individuals applying based on eligibility for

appointment due to a disability.  The SF-50 is a form current and

former Federal employees must submit to document their Federal

employment status. 

 

Below is a list of supporting documents for this announcement.  This

is not an all-inclusive list of supporting documents.  Please only

submit the documents that are APPLICABLE to you as an individual

applicant:

 

--STATUS APPLICANTS--

A Status Applicant is a current career or career-conditional Federal

employee or former Federal employee who has reinstatement

eligibility.  As a status applicant, you must fax a copy of your

Notification of Personnel Action, SF-50, or equivalent showing your

full performance level or career ladder. The SF-50 MUST

verify current grade, promotion potential, reinstatement eligibility

or highest federal civilian grade.  Please DO NOT send Awards

or Pay Adjustment SF-50s. 

 

You may obtain a copy of your SF- 50 from your Human Resources

Office or HHS employees may download a copy from here Electronic Personnel Folder

 

If you have separated from Federal Government employment, you may

obtain a copy of your SF-50 via:

Federal Records Center National, Archives and Records Administration

111 Winnebago Street, St. Louis, MO 63118-4126 or

CPR.CENTER@NARA.GOV, or VISIT the NATIONAL ARCHIVES WEBSITE

 

--EDUCATION DOCUMENTS--

You must fax copies of your college transcripts if using education

to qualify or if the position requires positive education.

UNOFFICIAL COPIES ARE ACCEPTABLE at the application phase; however,

you will be required to provide official transcripts upon entry on

duty.  (See paragraph under education if you are currently in series

advertised.)  All foreign degrees must be evaluated by a nationally

recognized Accrediting Agency.  You must submit proof of such

evaluation and/or conversion.  See the National Association of Credential Evaluation Services website.

This list, which may not be all inclusive, is for informational

purposes only and does not imply any endorsement of any specific

agency.

 

--CTAP/ICTAP (FOR DISPLACED EMPLOYEES)--

If you are applying under the Career Transition Assistance Program

(CTAP) or under the Interagency Career Transition Assistance Program

(ICTAP), please FAX a copy of your SF-50 and RIF Notice dated within

one year.

 

Information regarding the CTAP can be found by clicking CTAP INFO

 

Information regarding the ICTAP can be found by clicking ICTAP INFO

 

 

 

--VETERANS--

If you are a veteran, please FAX a copy of your DD214, which states

the type of discharge received.   If you are a disabled veteran,

please FAX a copy of your DD214, SF-15 and a copy of your VA

Disability Letter issued after 1991 or later documenting a service-

related disability. 

 

Information regarding the eligibility requirements for 5-point and

10-point veterans' preference can be found by clicking HERE.

 

If you encounter technical difficulties during the faxing process

please call the Rockville Center HelpDesk at 1-888-478-4340 Monday

through Friday, 7:30AM to 5:00PM EST (excluding Federal holidays).


Contact Information:

Rockville Center HelpDesk
Phone: 888-478-4340
Fax: 571-258-4052
TDD: 800-877-8339
Email: quickquestions@psc.gov
Or write:
Department of Health and Human Services
Rockville HR Center
5600 Fishers Lane, Room 17-38
Rockville, MD 20857
Fax: 571-258-4052


What To Expect Next:

Once the online questionnaire is received, you will receive an

acknowledgement email that your submission was successful. Once the

announcement closes, we will review applications to identify the

best qualified candidates. Due to a high volume of phone calls

and emails, please useMYUSAJOBS WEBSITE

to check the status of your application.  The most highly

qualified candidates will be referred to the hiring manager for

further consideration and possible interview.



The United States Government does not discriminate in employment on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, marital status, disability, age, membership in an employee organization, or other non-merit factor.

Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application and hiring process should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis.


 


Send Mail to:
Department of Health and Human Services
Rockville HR Center
5600 Fishers Lane, Room 17-38
Rockville, MD 20857
Fax: 571-258-4052
For questions about this job:
Rockville Center HelpDesk
Phone: 888-478-4340
Fax: 571-258-4052
TDD: 800-877-8339
Email: quickquestions@psc.gov


Control Number: 1312955

 

Note: We cannot accept applications on behalf of Federal Agencies. Application instructions are listed within the Job Description.

 

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