Title 21 Vacancy Announcement

Department of Health and Human Services (HHS)

Food and Drug Administration (FDA)

Center for Veterinary Medicine (CVM)

Office of the Director (OD)

Position: Regulatory Counsel  

Pay Plan-Series: AD-0301

Location: Duty station negotiable after selection

Travel Requirements: <25%

Application Period: December 9, 2021 – January 6, 2022

Salary: Starting at $87,198 (Cures Band B/C)

Area of Consideration: United States Citizens or Nationals

Relocation Expenses Reimbursement: Relocation expenses will not be paid.

Special Notes: This position is being filled under a streamlined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. Additional information on 21st Century Cures Act can be found here:

21st Century Cures Act Information.

Introduction

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 mission of the Center for Veterinary Medicine (CVM) is to protect and promote human and animal health. CVM ensures the safety of the American food supply, the safety of animal food and devices, and the safety and effectiveness of animal drugs. Specifically, CVM evaluates new animal drug applications for safety and effectiveness; monitors animal drugs, foods, and devices on the market; evaluates animal food additives for safety and utility; and conducts applied research to further protect human and animal health. As a high-performance organization within the FDA, CVM strives for excellence, innovation, and leadership across all operations, occupations, and grade levels.

The Office of the Director (OD) has primary responsibility for establishing and coordinating the overall regulatory policy and scientific direction of the Center. OD is also responsible for the Center's Freedom of Information Act activities, stakeholder outreach and engagement, customer service through the Ombudsman, international relations, as well as information management operations involving website content and 508 Compliance requirements. In addition, the Office provides individual and team coaching services and internal organizational change advice in support of CVM's operation as a High Performance Organization. To learn more about OD click here.

Duties/Responsibilities

As a Regulatory Counsel on OD’s Freedom of Information Act (FOIA) Staff, you will:

• Conduct legal analyses of CVM and Agency records to determine whether documents can be released in litigation or in response to third-party subpoenas.
• Prepare responses to information requests from stakeholders while ensuring compliance with established CVM/FDA regulations, policies, and procedures.
• Provide advice and guidance to senior management and stakeholders on information requests involving litigation disclosure.

Conditions of Employment

• S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• This position is subject to the COVID-19 vaccine mandate as a condition of employment. In accordance with Executive Order 14043, Federal employees are required to be fully vaccinated against COVID-19 regardless of the employee’s duty location or work arrangement (e.g., telework, remote work, etc.), subject to exceptions that may be required by law. If selected, you will be required to submit proof of vaccination by November 22, 2021 or before your entrance on duty if you are selected after the compliance date. Your HR Consultant will provide a list of documents acceptable as proof of vaccination and instructions for how to submit a request for a legally required exception, if needed, to comply with vaccination requirement.
• Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
• Applicants must meet all qualification requirements by the closing date of this announcement.
• Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
• Males born after December 31, 1959 must be registered with the Selective Service.
• One year probationary period may be required.
• Financial Disclosure may be required.
• Ethics Clearance may be required.
• Background Investigation/Security Clearance is required. All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.

Qualifications

Education Requirements: A juris doctorate degree from an accredited institution of higher learning.

Professional Experience Requirements:

§  Applying Exemption B4 (Trade Secrets / Confidential Commercial Information) in the review of proprietary information;

§  Conducting legal analysis to prepare justifications for the withholding and/or redaction of documents or portions of documents during the litigation process, including preparation of Vaughn Indexes or Privileged Logs associated with FOIA; and

§  Redacting information from documents that are exempt from disclosure per the Freedom of Information Act (FOIA).

Additional Desired Experience:

2 years in an attorney or regulatory professional role providing advice on federal regulatory issues.

Ethics Clearance Requirements

This position may require financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For more information please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.

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.

Equal Employment Opportunity (EEO) for federal employees & job applicants

Reasonable Accommodation Policy

Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis. A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits. Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when: An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job. An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace. An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events. You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis. Learn more about disability employment and reasonable accommodations or how to contact an agency.

E-Verify

The Food and Drug Administration participates in the USCIS Electronic Employment Eligibility Verification Program (E-Verify). E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers.

How to Apply

Please submit your letter of interest, resume, and copy of transcripts by January 5, 2022 to: CVMOpportunities@fda.hhs.gov with the subject line of “Cures Regulatory Counsel –United Latinos Job Board– OD.”

Announcement Contact

For questions regarding this announcement, please contact CVMOpportunities@fda.hhs.gov using the subject line provided above.     

Safeguarding human and animal health is what we do. When you join our team, you impact this unique and amazing mission no matter your position. You also join a diverse community of exceptional people who encourage and support everyone to dream, inspire each other, and live our best lives, personally and professionally. When you join CVM, you join an incredible place to work.

The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.

FDA is an equal opportunity employer.