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

Job Title:Deputy Center Director for Policy

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:FDA-ES-14-CDRH-1135071

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

The contents of the announcement can still be viewed.

SALARY RANGE:

$120,749.00 to $181,500.00 / Per Year

OPEN PERIOD:

Monday, June 09, 2014 to Wednesday, July 09, 2014

SERIES & GRADE:

ES-0301-00

POSITION INFORMATION:

Full Time - Senior Executive Service (SES)

DUTY LOCATIONS:

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

WHO MAY APPLY:

All groups of qualified individuals

SECURITY CLEARANCE:

Confidential

SUPERVISORY STATUS:

Yes

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 in the Senior Executive Service (SES), a small elite group of senior government leaders who possess a diverse portfolio of experience and the strong skills required to lead across organizations.  This dedicated corps of executives is charged with providing strategic leadership and upholding a commitment to public service that transcends loyalty to a specific agency mission or individual profession.  As an SES member you will influence the direction of innovation and transformation of the federal government and lead the next generation of public servants. 

 

The Food and Drug Administration is the regulatory, scientific, public health and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe, and for tobacco product regulation in order to decrease the tremendous toll of disease, disability, and death caused by tobacco use in the United States. FDA’s programs are national in scope and effect, and the agency’s activities have a direct and significant impact on multi-billion dollar industries, in addition to protecting the health and safety of American consumers. The work of the Agency is carried out by a staff of over 12,000 scientists, physicians, regulatory and other personnel stationed throughout the United States.

 

The position of Deputy Director for Policy is located in the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) in Silver Spring, MD. 

TRAVEL REQUIRED

  • Occasional Travel
  • Travel may be required.

RELOCATION AUTHORIZED

  • Yes
  • Relocation or recruitment incentive may be authorized.

KEY REQUIREMENTS

  • U.S. Citizenship is required.
  • Background and/or Security Investigation required.
  • Must complete 1 year SES probationary period, if not previously completed.
  • Application package must be received by closing date of the announcement.

DUTIES:

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The position of Deputy Director for Policy is located in the Center for Devices and Radiological Health which has the responsibility to plan, develop and administer regulatory policies and programs related to the safety and effectiveness of medical devices and radiation-emitting electronic products produced or marketed in the United States. As Deputy Director for Policy, the incumbent:

 

Participates with the Center Director in the management of CDRH by providing leadership in the development, implementation and evaluation of regulations, guidances, legislative proposals and other policies as they relate to the Center’s broad national and international programs and activities to ensure the safety, effectiveness, quality  and accurate labeling of all medical devices and radiation-emitting electronic products.

 

Advises the Center Director, senior FDA officials and others on all regulatory and policy making activities that affect Center-wide programs, projects and initiatives or have an impact on the development and achievement of long-range program goals.

 

Provides executive leadership and assists the Director in formulating and developing CDRH’s short and long-range goals, advancing regulatory programs, and promoting an understanding of FDA’s responsibilities for enforcing regulatory standards to protect and promote public health.

 

Represents the Director and FDA, and participates as the Center’s authority, on all policy matters related to federal regulations for medical devices and radiation-emitting electronic products.

 

 

 


QUALIFICATIONS REQUIRED:

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Specialized Experience Requirement

To be qualified for this position, you must provide evidence of specialized experience in a managerial capacity with responsibility for medical product-related Food and Drug law, such as the development, implementation and/or evaluation of statute, regulations, guidances, and/or other policies related to medical product regulation; making independent legal/regulatory judgments regarding medical product-related issues. This experience must be evidenced by superior written and oral communication skills, experience interacting with one or more of the medical product industries and/or FDA officials, superior strategic, analytical, interpersonal and problem solving skills. Typically, experience of this nature is gained at or above the GS-15 grade level in the Federal service, or its equivalent with state or local government, the private sector, or nongovernmental organizations.

 

Senior Executive Service Requirements

Unless you are currently serving under a career SES appointment, are eligible for reinstatement into the SES, or have successfully completed a SES Candidate Development Program approved by OPM, you must submit a narrative statement via the assessment questionnaire covering each of the Executive Core Qualifications (ECQs) in order to receive consideration for the position. Current or former career SES employees are not required to address the ECQs, but must address the Technical Qualifications (TQs) in a narrative statement via the assessment questionnaire.


Public Health Service Commissioned Corps Officers interested in applying for this position to serve in the SES must resign their commission, if selected.  If you are applying under this option, you must address both the TQs and ECQs in a narrative format in the assessment questionnaire within the announcement. Public Health Service Commissioned Corps Officers interested in performing the duties of the position within the Commissioned Corps must address the TQs in a narrative format within the assessment questionnaire, but are not required to address the ECQs.

 

Additional information on the proper preparation of ECQs is available by going to the Office of Personnel Management's web site at http://www.opm.gov/ses/references/GuidetoSESQuals_2010.pdf.  Applicants are encouraged to follow the Challenge, Context, Action, and Result model outlined in the guide.

 

When responding to the ECQs, you must clearly show that you possess the experience, knowledge, skills and ability to perform the duties of this position by submitting narrative responses in which you detail your experience in each of the ECQs.

 

Your examples should be clear and emphasize your level of responsibilities, scope and complexity of programs managed, program accomplishments with results of your actions, policy initiatives and level of contacts.  In addition, your responses should highlight your experience, training, and achievements in conjunction with the resume that you provide.  You should limit your narrative to two pages per each ECQ, for a total of 10 pages.

 

In order to satisfy all of the specified requirements, you must submit narrative responses via the assessment questionnaire addressing the TQs and five ECQs outlined below.

 

Technical Qualifications

 

  1. 1. Five years of demonstrated experience working with Food and Drug law as it pertains to medical products (i.e., medical devices, drugs, or biologics).
  2. 2. Demonstrated management capabilities within a diverse organization, such as overseeing a team of lawyers.
  3. 3. Superior communication skills.

 

Desired Qualifications

 

  1. 1. Knowledge of current issues and policies associated with the regulation of medical products (i.e., medical devices, drugs, or biologics).
  2. 2. Skill in identifying, analyzing, managing, solving and providing comprehensive advice on highly complex legal/regulatory issues.
  3. 3. A law degree from and accredited institution.

 

 

Executive Core Qualifications

Fundamental Competencies:  The following competencies are the foundation for success in each of the ECQs.  Interpersonal Skills; Oral Communication; Integrity/Honesty; Written Communication; Continual Learning; and Public Service Motivation.  These Fundamental Competencies are cross-cutting and should be addressed over the course of your ECQ narratives.

 

1.  Leading Change:  This core qualification involves the ability to bring about strategic change, both within and outside the organization, to meet organizational goals.  Inherent to this ECQ is the ability to establish an organizational vision and to implement it in a continuously changing environment. (Competencies:  creativity and innovation, external awareness, flexibility, resilience, strategic thinking, vision)

 

2.  Leading People:  This core qualification involves the ability to lead people toward meeting the organization's vision, mission, and goals.  Inherent to this ECQ is the ability to provide an inclusive workplace that fosters the development of others, facilitates cooperation and teamwork, and supports constructive resolution of conflicts. (Competencies:  conflict management, leveraging diversity, developing others, team building)

 

3.  Results Driven:  This core qualification involves the ability to meet organizational goals and customer expectations.  Inherent to this ECQ is the ability to make decisions that produce high quality results by applying technical knowledge, analyzing problems, and calculating risks.  (Competencies:  accountability, customer service, decisiveness, entrepreneurship, problem solving, technical credibility)

 

4.  Business Acumen:  This core qualification involves the ability to manage human, financial, and information resources strategically.  (Competencies:  financial management, human capital management, technology management)

 

5.  Building Coalitions:  This core qualification involves the ability to build coalitions internally and with other Federal agencies, State and local governments, nonprofit and private sector organizations, foreign governments, or international organizations to achieve common goals.  (Competencies:  partnering, political savvy, influencing/negotiating)


 

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.

 

All initial appointments to an SES position are contingent on approval from OPM's Qualifications Review Board unless the selectee has successfully participated in an OPM approved SES Candidate Development Program.

 

In accordance with Federal and Agency Travel regulations, the payment of travel and relocation expenses may be reimbursed for travel, transportation and relocation expenses associated with reporting for duty to this position.

 

As a condition of employment, all male applicants born after December 31, 1959, must have registered for the selective service.  If selected for this position, the applicant must sign a statement certifying his registration, or the applicant must demonstrate exempt status under the Selective Service Law.

 

Only experience obtained by the closing date of this announcement will be considered.

HOW YOU WILL BE EVALUATED:

Your resume and narrative responses to the technical qualifications and the five Executive Core Qualifications are an integral part of the process for determining your basic and specialized qualifications for the position.  Responses that are not supported by your resume will eliminate you from consideration.  Your application will be evaluated in the following manner: 

1.  Application packages will be reviewed for completeness (incomplete or late packages will not receive further consideration).

 

2.  Basic qualifications review.  Your resume and questionnaire will be reviewed to ensure that you meet the Specialized Experience Requirement.  (If you do not meet this requirement, you will not receive further consideration).

 

3.  Review of your supplemental qualifications document to determine your rating.


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:

Veteran's Preference does not apply to the SES.



HOW TO APPLY:

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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 Wednesday, July 09, 2014.

 

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 Vacency Identification Number:  1135071.  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 ERIC Call Center 301-827-3742 Center HelpDesk , TTY/TTD (800)877-8339; or email eric@fda.hhs.gov.  You must contact the ERIC Call Center HelpDesk prior to the closing date of this announcement to receive assistance.  The decision on granting reasonable accomodation will be made on a case-by-case basis.  Hours of operation:  Monday through Friday 7:30AM to 6:00PM EST.



REQUIRED DOCUMENTS:

Required Documents

 

  1. Resume - Ensure that your resume contains your full name, address, phone number, and social security number.  When uploading your resume, choose the supporting document type called "Resume;"
  2. Completion of online Questionnaire to include the narrative response to the TQs to be completed within the assessment questionnaire;
  3. ECQs - The ECQ narratives must be addressed directly in the assessment questionnaire. This is required for all applicants who are not currently serving under a career SES appointment, eligible for reinstatement into the SES, graduates of an OPM-certified Candidate Development Program, or Commissioned Corps Officers who wish to apply for this vacancy as Commissioned Corps;
  4. SF-50, showing your current or former civil service status, if applicable; and
  5. Proof of OPM Qualifications Review Board certification (OPM-approved SES Candidate Development Program graduates), if applicable.

 

If you do not submit the documents above by the closing date of the announcement, the system will consider your application incomplete, and you will receive no further consideration.  Any documents submitted that are not listed above will not be considered or forwarded to the rating panel or selecting official.

AGENCY CONTACT INFO:

Kisha Hightower
Phone: (240)402-4350
TDD: 800-877-8339
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:

We expect to make a selection within 90 days of the closing date of this announcement.  You will be notified of the outcome by e-mail using the e-mail address on file in the Application Manager system, or by postal mail if no email address was provided by you during the application process.


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Job Announcement Number:

FDA-ES-14-CDRH-1135071

Control Number:

371687800