Duties

Summary

The Director, Office of Regulations and Policy, Center for Food Safety and Applied Nutrition (CFSAN) provides leadership in the development of regulations, guidance documents, policies, and legislative proposals to implement the Center's mission to ensure the safety of foods and cosmetics and to implement nutrition initiatives aimed at improving public health and serves as the principal advisor to the Center Director and other senior Agency officials on these matters.

Learn more about this agency

Responsibilities

• Provides executive leadership for the development of CFSAN regulations and guidance documents, and for reviewing and clearing draft regulations developed by other agencies impacting foods, cosmetics and the Agency?s broad nutrition initiatives.
• Exercises leadership and analytical judgment to anticipate potential problems and sensitive issues in the resolution of complex and precedent-setting regulatory or policy documents insofar as they may have an impact on CFSAN?s goals and mission.
• Oversees the development of regulations, obtains the appropriate clearances from the Department and OMB and explains the public health impact of these regulations to the media, Congress, industry and the public.
• Provides senior leadership to staff in the development of legislative proposals related to foods, cosmetics and FDA?s broad nutrition initiatives.
• Reviews draft Congressional bills and proposed legislation related to foods, cosmetics and FDA?s broad nutrition initiatives.
• Provides technical assistance to Congressional staff developing legislative proposals and draft bills related to related to foods, cosmetics and FDA?s broad nutrition initiatives.
• Provides senior leadership and direction to staff responsible for managing the Center?s Freedom of Information Act activities, coordinating responses with other Center technical, regulatory, and policy units as well as developing direct responses.
• Provides senior leadership and direction to staff responsible for compliance with the Paperwork Reduction Act.
• In consultation with the Center Director and Deputy Directors, develops plans that support priority setting and administrative review of regulations and guidance documents and strategic initiatives.
• Works in collaboration with CFSAN and Office of Food Policy and Response to assist CFSAN senior leaders in establishing priorities and monitoring progress towards organizational goals to ensure that progress towards goals is achieved as directed.
• Provides advice, guidance, interpretations, and recommendations to the Center Director and other senior FDA and Department officials; Federal, State or local governmental counterparts on controversial issues related to CFSAN regulations.
• Represents CFSAN in meetings with top level Department and Agency officials, OMB, members of Congress and/or their representatives, academic organizations, foreign officials, personnel from other Federal agencies, State and local government agencies.

Travel Required

Not required

Supervisory status
Yes

Promotion Potential
00

Requirements

Conditions of Employment

• U.S. Citizenship is required for federal employment.
• Background and/or Security Investigation is required.
• Must complete 1-year SES probationary period, if not previously completed.
• Application package must be received by closing date of this Announcement.
• Ethics pre-clearance is required.

Qualifications

In order to qualify for Director, Office of Regulations and Policy, 0340, ES - 00, you must possess the following:

• Specialized Experience Requirement
• Basic Qualification Requirements
• Technical Qualifications (TQs)
• Executive Core Qualifications (ECQs)

Specialized Experience Requirement
To be qualified for this position, your résumé must reflect experience in a managerial capacity with responsibility for providing supervisory direction to a large and diverse organization responsible for promoting economy, efficiency, and effectiveness in the administration of programs and operations and preventing and detecting fraud and abuse in such programs and operations. This experience must be evidenced by sophisticated analytical skills, superior written and oral communication skills, good judgment, and experience in interacting with government and non-government officials. 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. At this level, you would have typically been responsible for planning, directing, and evaluating work that included managing and/or supervising other managers. You must demonstrate in your résumé, significant achievements, increasing levels of responsibility as a manager, and a solid record of successful professional performance.

Basic Qualifications Requirement
As a basic requirement for entry into the Senior Executive Service (SES), your résumé must show evidence of progressively responsible leadership experience that is indicative of senior executive level management capability, and that is directly related to the skills and abilities outlined under:

1) Technical Qualifications (TQs); and
2) Executive Core Qualifications (ECQs)

Technical Qualifications (TQs) -- Your résumé must show that you possess the following TQs:
1. Knowledge of the Federal, Food, Drug, and Cosmetic Act gained from experience related to the interpretation, application, explanation, or enforcement of its laws, rules and regulations.
2. Senior level experience in the federal regulatory process which included the development and evaluation of regulations, guidance documents, and policies for national and/or international programs.
3. Strong leadership and thorough knowledge and effective skills in administration and management with emphasis in a regulatory review or public health environment.
4. Strong oral and written communication skills as evidenced by experience drafting guidance documents, regulations, notices of proposed rulemaking and final rulemaking, or petition responses; and making oral presentations on complex regulatory issues or providing advice to senior officials and stakeholders.

Desirable Qualification (DQ)-It is desired that you have the following (please show in résumé if you possess this
qualification):
1. Law degree from an accredited university.

Public Health Service Commissioned Corps Officers interested in applying for this position to serve in the SES must resign their commission if selected.

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.

Executive Core Qualifications (ECQs) -- Your résumé must show that you possess the following ECQs:

1.Leading Change
2. Leading People
3. Results Driven
4. Business Acumen
5. Building Coalitions

Fundamental Competencies are the foundation for success in each of the ECQs and should be evident over the course of your résumé:

1. Interpersonal Skills
2. Oral Communication
3. Integrity/Honesty
4. Written Communication
5. Continual Learning; and
6. Public Service Motivation

It is STRONGLY recommended that you visit the following Office of Personnel Management (OPM) webpage for more information regarding the Fundamental Competencies and ECQs. https://www.opm.gov/policy-data-oversight/senior-executive-service/executive-core-qualifications/.

1. Leading Change: 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: 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: 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: The ability to manage human, financial, and information resources strategically. (Competencies: financial management, human capital management, technology management)

5. Building Coalitions: 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)

The application process for this position is RESUME ONLY. You should address the TQs, DQ, and ECQs within the context of a 5-page résumé. Any information submitted in excess of 5 pages WILL NOT be considered. We strongly encourage you to submit a résumé that is tailored specifically for this position to ensure it includes relevant examples of how you possess the technical qualifications and the five Executive Core Qualifications. Your résumé should emphasize your level of responsibilities, the scope and complexity of programs managed (e.g., budget, type/# of staff supervised) and program accomplishments, including the results of your actions.

If selected, you will be required to complete an ECQ package by drafting narratives for each of the ECQs for submission and certification by an OPM Qualifications Review Board (QRB) in order to be placed in this position. If you are currently serving in a career SES appointment, are eligible for reinstatement into the SES, or have successfully completed an SES Candidate Development Program approved by the Office of Personnel Management (OPM), you will not need to draft the ECQs.

Education

There is no education requirement for this series.

Additional information

• If you are serving or have served in the last 5 years from the closing date of this announcement as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. Political Appointee FAQ - OPM
• Probationary Period: Persons newly selected for career appointment to the SES must have their ECQs approved by the OPM Qualifications Review Board and will be required to serve a one-year probationary period.
• Relocation/Moving Expenses: Will not be authorized.
• A one-time Relocation or Recruitment incentive may be offered.
• Mobility: Individuals selected for SES positions may be subject to reassignment across geographic, organizational, and functional lines.
• Direct Deposit: All Federal employees are required to have Federal salary payments made by electronic direct deposit to a financial institution of their choosing.
• Selective Service: As a condition of employment, all male applicants born after 12/31/1959, 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.
• Veterans' Preference: Does not apply to the SES.
• 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 Bethesda Center HelpDesk (888) 478-4340; TTY/TDD: (866) 539-4484; or by email quickquestions@fda.hhs.gov. The decision on granting reasonable accommodation will be made on a case-by-case basis.
• Equal Employment Opportunity: The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.
• 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.

Benefits for federal employees:
https://www.usajobs.gov/Help/working-in-government/benefits/

How You Will Be Evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

Once the job opportunity announcement closes (at 11:59 pm ET on 07/03/2019).

Your résumé and responses to the Assessment Questionnaire are an integral part of the process for determining your basic and specialized qualifications for the position. Responses that are not supported by your résumé 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 résumé 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. If it is determined that you meet the basic qualifications for the position, your application package will be further evaluated by a rating and ranking panel, and highly qualified candidates may be invited to participate in a structured interview, submit writing samples, and undergo reference checks. Top candidates may be required to submit further written documentation of qualifications.

4. The HHS FDA Executive Resources Board will review results and make recommendations on final selections to the appointing authority.

All information concerning qualifications is subject to investigation. You should expect that we will verify performance, suitability, security information and take that information into account in making employment offers. False representation may be grounds for non-consideration, non-selection, and/or appropriate disciplinary action. 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. An individual's initial SES career appointment becomes final only after the individual successfully completes a 1-year probationary period. For additional information concerning the SES visit http://www.usajobs.gov/SeniorExecutives.

Background checks and security clearance

Security clearance
Secret

Drug test required
No

Required Documents

You are encouraged to apply online. Applying online will allow you to review and track the status of your application.

All applicants are required to submit the following supporting document type(s):

• Resume
• SF-50 (showing current status as current federal employee or SES reinstatement eligibility)

Applicants may also submit the following supporting document type(s),which may not be required for all applicants:

• Cover Letter
• Other (QRB Certification, if applicable)

We strongly encourage you to submit a résumé that is tailored specifically for this executive position to ensure it includes relevant examples of how you possess the technical qualifications and the five Executive Core Qualifications. Your résumé should emphasize your level of responsibilities, the scope and complexity of programs managed and program accomplishments, including the results of your actions.

• Applicants typically provide the following information in their résumé:
• Vacancy announcement number and title of position -
• Full name, mailing and email addresses, day and evening telephone numbers.
• Educational information, including the name, city and state of colleges or universities attended, as well as the type of degree received.
• Information about paid and unpaid work experience related to the position, including: title, duties and accomplishments, employers' name and address, duration of employment, and salary (or Grade, if Federal).
• Information about honors, awards, and special accomplishments.

Financial Disclosure Reporting: The Ethics in Government Act, PL 95-521 requires the applicant selected for this position to submit a Public Financial Disclosure Report (OGE form 278) prior to assuming the SES position, annually, and upon termination of employment. Visit the Office of Government Ethics website at www.oge.gov and select Financial Disclosure. Frequently Asked Questions can be found at FAQs/. https://www.oge.gov/web/oge.nsf/Public%20Financial%20Disclosure.

Do NOT include Personally Identifiable Information (PII) such as Social Security Number or Date of Birth on your résumé.

For Most Effective Resumes Tips visit: https://help.usajobs.gov/index.php/Most_Effective_Resumes

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Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.

If you are relying on your education to meet qualification requirements:

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education .

Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.