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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
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