This position is located in the Office of the Chief Counsel (OCC), Food and Drug Division (FDD), Food and Drug Administration (FDA) in Silver Spring, MD. The incumbent serves as a principal legal counselor and advisor to Commissioner of the Food and Drug Administration on all FDA enforcement and litigation matters.

Duties

Serves as a principal legal counselor on all civil and criminal litigation matters for FDD. Serves as a senior-most leader for the assigned litigation programs areas: directs, plans, organizes and manages all aspects of those FDA litigation activities and programs for FDD. Resolves complex and difficult matters of interpretation of the applicable statutes and FDA regulations, and assesses applicable FDA guidance. Provides authoritative advice and counsel to FDA leadership on specific litigation matters related to foods, drugs, biologics, tobacco, medical devices, cosmetics and radiation products. Counsels and works closely with senior FDA officials on agency enforcement strategy for the full range of products that FDA regulates under different authorities. Develops and oversees litigation strategy and tactics for enforcement and defensive cases. Develops and manages a plan to provide litigation services to the FDA client components. Provides training on legal issues to FDA components. Directs all aspects of FDA litigation, including review and evaluation of proposed cases, strategy development, pleadings, briefing, oral advocacy, and settlement negotiations. As a key member of the OCC management team; participates fully with leadership on program and policy issues affecting the office, participates fully in decisions concerning resource requests and allocations, personnel acquisition and development.

Requirements

• 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/Financial Disclosure is required.

Qualifications

In order to qualify for Deputy Associate General Counsel for Litigation 2, 0905, ES - 00, you must possess the following: Specialized Experience Requirement Basic Qualification Requirements Education Requirements and Bar Membership Technical Qualifications (TQs) Executive Core Qualifications (ECQs) Specialized Experience Requirement To be qualified for this position, your resume 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 resume 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 resume 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 resume must show that you possess the following TQs: 1. Substantial experience and demonstrated expertise in food and drug law litigation, including application and 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 litigation briefs, 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. Extensive practice before federal courts. Executive Core Qualifications (ECQs) -- Your resume 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 resume: 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 resume. Any information submitted in excess of 5 pages WILL NOT be considered. We strongly encourage you to submit a resume 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 resume 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.

Education

You must have earned a professional law degree (e.g. J.D.) from a law school accredited by the American Bar Association and be an active member and be in good standing of the Bar in a State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.

You must include a copy of current/active Bar Membership under supporting documents tab "license" and transcripts.

Contacts

• Address FDA Office of the Commissioner 10903 New Hampshire Ave Silver Spring, MD 20993 US
• Name: Jacquell Green
• Email: [email protected]