Clarification from the agency

Those applicants who meet the mandatory qualifications of the announcement.

• Serves as a principal legal counselor and advisor to the Commissioner of Food and Drugs on all matters within the assigned program areas concerning: the interpretation and application of complex laws, regulations and guidance.
• Responsible for the success of the legal activity related to the assigned programs.
• As the senior-most leader for the assigned program area, directs, plans, organizes, and manages all aspects of FDA legal advisory and program review activities for assigned program areas.
• Resolves complex and difficult matters of interpretation of the applicable statutes and regulations.
• Researches and coordinates with HHS Deputy General Counsels (DGC), Associate General Counsels (AGC) and Deputy Associate General Counsels(DAGC), and with the senior legal staff of other agencies and departments.
• Represents FDA in meetings with senior officials of other federal agencies and departments, outside HHS, such as the Department of Defense, the Federal Trade Commission, the Department of Agriculture, and the Environmental Protection Agency.
• Provides authoritative legal advice to the FDD AGC, other AGCs and Deputies throughout HHS OGC, the HHS General Counsel and DGCs, Directors of FDA Centers, Offices, and program areas, the FDA Commissioner, and other senior FDA staff.
• Provides strategic legal counsel on the applicability of existing laws and regulations to specific and often unique and complex situations relating to assigned program areas.
• Develops plans of service to provide legal advisory and program review services to FDA clients, recommends the staff and other resources necessary to provide such services, determines priorities, and monitors progress.
• Regularly meets with FDA Centers and Office of Policy to discuss priorities and planning.
• When and as necessary, evaluates progress toward program goals and then independently, or with senior leadership from the assigned program area, makes appropriate adjustments to overall goals.
• Directs all legal aspects of the review and evaluation of complex proposed legislation, regulations, and other non-litigation regulatory action documents pertinent to the assigned programs.
• Provide strategic advice to senior scientific, enforcement, and regulatory staff on program matters, policy, and strategy particularly when they involve new and untested legislation or implementing regulations.
• Manage program review support of FDD litigation activities including defensive litigation.
• Provides testimony or makes presentations to Congress, the Office of Management and Budget, or other bodies, either personally or as legal advisor to FDA's most senior leadership in the assigned program area or in the Office of the Commissioner.
• Selects and supervises senior subordinate attorneys to provide such services and ensures that they are thoroughly briefed and cognizant of issues and matters to be discussed.

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 Deputy Associate General Counsel for Program Review (Foods and Veterinary Medicine), 0905, ES - 00, you must possess the following:

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

Please note: This position is being advertised in both the Foods/Veterinary Medicine program area and the Drugs/Biologics program area. To be considered for both you must apply to both announcements. The Drugs/Biologics announcement can be found on usajobs.gov, Vacancy Announcement Number: FDA-OC-ES-23-11827052SB.

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. Substantial practice and demonstrated expertise in food and drug law, including application or enforcement of the Federal Food, Drug, and Cosmetic Act and other statutes administered by the Food and Drug Administration (FDA).
2. Proven record of success in managing and leading a legal office, component, or significant team, including: effective training and development of staff; efficient use of human and information resources; effective internal and external communication; problem-solving and decision making; planning and formulation of legal strategy; and prioritizing work and ensuring timely response to urgent matters.
3. Preparation of memoranda, legal documents or reports, outlining facts and legal issues, analyzing factual and legal issues involved, explaining the application of legal principles and precedents, and justifying recommendations or conclusions for senior government officials or high-level officials in the private sector.
4. Familiarity with the administrative law, including rulemaking and other regulatory tools; familiarity with statutory development and legislative oversight.

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)

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.

The application process for this position is RESUME ONLY. You should address the TQs 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.

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

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 03/09/2023).

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.