Director Office of Strategic Planning and Operational Policy

Employer
USAJobs
Location
Rockville, Maryland
Posted
Jun 15, 2019
Closes
Jun 22, 2019
Hours
Full Time
Duties

Summary

The Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective.

The Office of Regulatory Affairs (ORA) leads all agency field activities, conducting inspections and investigations of regulated products and manufacturers.
Learn more about this agency

Responsibilities

  • The Director, Office of Strategic Planning and Operational Policy (OSPOP) serves as the principal advisor and spokesperson for ORA in matters related to the development and implementation of new policy initiatives in the areas of all ORA programs;
  • Including, but not limited to compliance policy, operational policy field work planning and performance evaluation, and Freedom of Information (FOI) and other information disclosure requests.
  • Advises the Associate Commissioner for Regulatory Affairs (ACRA), Assistant Commissioner for Partnerships and Policy (ACPP), senior FDA officials, and others on all regulatory and policy-making activities that affect FDA and ORA programs.
  • Maintains knowledge and awareness of the ACRA's and ACPP's interests and objectives in all matters and provides authoritative counsel on developing and implementing regulations.
  • Responds to citizen petitions, fulfilling ORA's disclosure obligations, drafting and implementing legislation, interpreting and implementing precedent-setting policy statements and adjudicatory decisions, handling user fee billing and waivers.
  • Implements the program for granting patent extensions under the Hatch-Waxman amendments to the Food, Drug, and Cosmetic Act, and other matters that may fall under the responsibility of the Office of Regulatory Affairs.
  • Oversees the development of policies related to posting and redaction of inspectional and compliance records, including compounding and user fee inspections.
  • Implements provisions of user fee agreements such as time reporting and work planning of user fee inspectional work, guidance or other agency policy, evaluation and reporting.
  • Evaluates ORA's overall efforts and activities, and as necessary, develops, establishes or recommends regulations and policies to the ACPP.
  • Develops documents and recommends policies involving inspections and field-based compliance activities, lab analyses, import entry reviews, enforcement actions, systems recognition or mutual reliance agreements, and other ORA programs.
  • Monitors user fee and overall activities throughout ORA, including reviewing prior issues for consistency of approach and providing leadership to key officials and program managers in resolving regulatory problems cutting across organizational lines.
  • Evaluates findings contained in program reports prepared by ORA and Agency organizational components. Ratifies and negotiates user fee agreements on behalf of ORA.
  • Represents and speaks for the ACPP in discussions, meetings, conferences, and consultations with top-level departmental and agency officials, national/international industry representatives, academic organizations and groups.
  • Represents the ACRA and ACPP, with top-level policymakers of FDA, HHS and OMB in the formulation of strategies, programs and budgets, and information systems.
  • Develops and manages ORA's strategic planning and performance management process, coordinating the development of ORA's strategic priorities, supporting those of the FDA while integrating ORA strategic priorities within the budget formulation cycle.
  • Serves as the principal source of expertise and advice to the ACRA and ACPP on improving processes and introducing new technologies on a field-wide, including global, enterprise-wide basis.
  • Performs substantive work and participates with the ACRA and ACPP by providing leadership in the development, implementation and evaluation of regulations and policies as they relate to ORA's broad national and international programs and activities.
  • Oversees the review and preparation of proposed regulations, final regulations, guidance, and other Agency documents regarding the practice and policies of ORA's surveillance and regulatory operations.
  • Oversees the review of all Agency-planned regulatory initiatives to determine the need for and to make recommendations concerning operational policies, enforcement strategies, and cross-cutting actions.
  • Provides executive leadership in the development, coordination, policy-setting, and oversight of ORA's engagement on Government Accountability Office studies, Department of Health and Human Services and Office of the Inspector General audits.


Travel Required

Occasional travel - You may be expected to travel for this position.

Supervisory status
Yes

Promotion Potential
00

Requirements

Conditions of Employment


Conditions of Employment:
  • U.S. Citizenship is required for federal employment.
  • Application package must be received by closing date of this Announcement.
  • Ethics pre-clearance is required.
  • Security and Background Requirements: 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.
  • 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.
  • Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing. All qualification requirements must be met by the closing date of the announcement.
  • Financial disclosure statement may be required.
  • One-year SES probationary period may be required. If not previously completed.
  • Bargaining Unit Position: NO
  • Drug Screening Required: NO
  • Recruitment or Relocation Bonus: May be authorized.
  • Relocation/Moving Expenses: May be authorized.
  • Supervisory position: YES
  • All qualification requirements must be met by 11:59 pm (Eastern Time) on 07/08/2019 ..

    Qualifications

    In order to qualify for the Director, Office of Strategic Planning and Operational Planning, 0301, 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 on a national level 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)
    2) Executive Core Qualifications (ECQs)

    In addition to specialized experience, applicants must possess the following technical qualifications that represent the knowledge, skills, and abilities essential to perform the duties and responsibilities of the position.

    Technical Qualifications (TQs)-- Your résumé must show that you possess the following TQs:
    1. Senior level public health experience as a leader in a complex public health or related regulatory organization in planning, directing, and evaluating broad applied scientific and/or regulatory programs and activities that demonstrate the ability to effectively coordinate and productively integrate multidisciplinary efforts.
    2. Senior level management experience which demonstrates the ability to build strong working relationships among people and organizations with diverse interests and/or opinions, including regulated industry, professional or public health, advocacy consumer organizations, Federal and State government partners, and the Congress.
    3. Senior level management experience which demonstrates the ability to supervise a large, multidisciplinary professional staff engaged in providing systematic program evaluation, integrated operational work planning and analysis, and policy advice to senior officials.

    Desirable Qualifications (DQs)-- It is desired that you have the following (please show in résumé that you possess these qualifications):
    1. Training, professional development, and outside professional activities that provide evidence of initiative, resourcefulness and potential for effective job performance at a senior level and honors, awards, or other recognition for performance or contributions related to the position.
    2. An advanced degree such as a Juris Doctorate, Doctor of Philosophy, Medical Doctor, Master in Business Administration, Master in Public Health, or a Master of Science in Public Health, Master of Science in Natural Science or Allied Health Degree.

    Public Health Service Commissioned Corps Officers: 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, your résumé must address the TQs, DQs, and ECQs in this announcement. Public Health Service Commissioned Corps Officers interested in performing the duties of the position within the Commissioned Corps must address the TQs and DQs within their résumé, but are not required to address the ECQs.

    Executive Core Qualifications-- 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
    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/.
  • 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)
  • 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)
  • 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)
  • Business Acumen: This core qualification involves the ability to manage human, financial, and information resources strategically. (Competencies: financial management, human capital management, technology management)
  • 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)
  • 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 position.

    Additional information

    • If you are serving, or have served in the last 5 years (from 07/08/2019) 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
    • Mobility: Individuals selected for SES positions may be subject to reassignment across geographic, organizational, and functional lines.
    • 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.

    This job opportunity announcement closes at 11:59 pm ET on 07/08/2019.

    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 this position, your application 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
    Not Required

    Drug test required
    No

    Position sensitivity and risk
    Moderate Risk (MR)

    Trust determination process
    Suitability/Fitness

    Required Documents

    All applicants are required to submit the following supporting document type(s):
    • Résumé
    • SF-50 (only required if you are a current or former federal employee)
    Applicants may also submit the following supporting document type(s),which may not be required for all applicants:
    • Cover Letter
    • SF-50
    • Transcript
    • Other (QRB/CDP Grad 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 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

    Please visit the YouTube Link for additional Tips: https://www.youtube.com/watch?v=bqYkibnuiJU

    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.

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