Job description

Title 21 Vacancy Announcement

Department of Health and Human Services (HHS)

Food and Drug Administration (FDA)

Center for Biologics Evaluation and Research (CBER)

Office of Vaccines Research and Review (OVRR)

Immediate Office of the Director (IOD)

Application Period: May 12, 2023 – June 2, 2023

Area of Consideration: The Public

United States Citizenship is required. You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration.

Position: Office Program Manager

Series: 0301

Location(s): White Oak Campus, Silver Spring, MD.

Work Schedule: Full Time

Salary: Starting at $112,015

Telework Eligible: Yes

Cures Band: Band C

Travel Requirements: 25% or less

Full Performance Band Level: Band C

Bargaining Unit: 3591

Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment, or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.

This position is being filled under a stream-lined 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.

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 Center for Biologics Evaluation and Research (CBER) is a Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. CBER’s mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. CBER protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.

The Office of Vaccines Research and Review (OVRR) protects and enhances public health by assuring those available vaccines, allergenic extracts, and related product are safe and effective.

Duties/Responsibilities

The Office Program Manager reports to and works with the Associate Director of Office Regulatory Initiatives (ADORI) and provides full programmatic and project management support for special office-wide program plans and initiatives, including vaccine workshops, advisory committee meetings, and other projects as needed. The incumbent anticipates the OVRR Office Director’s (OD's) needs for materials and takes initial step to ensure their development by the OVRR IOD and/or appropriate OVRR divisions, branches, and labs.

Specifically, the Office Program Manager will:

• Fulfill urgent and/or important programmatic and project management tasks at the request of and on the behalf of the OVRR OD and IOD.
• Provide analytical support on issues such as workforce planning, assist in coordinating workforce plans and compilation of data, and conduct assessments of potential workforce issues.
• Monitor incoming and outgoing OVRR OD communications and action documents to ensure that responses are prepared, and deadlines are met. This includes reviewing correspondence prepared for the OVRR OD's signature for readiness, ensuring proper coordination and compliance with the OVRR IOD and OD viewpoints, and composing memoranda and letters in accord with the OD’s directions.
• Manage the routine (weekly and monthly) OVRR IOD and OVRR leadership team meetings, including agenda setting, capturing, and distributing meeting summaries and actions/decisions/issues (ADI), and maintain and follows-up on Risks, Actions, Issues and Decision (RAID) log items.
• Manage special crosscutting initiatives and task force groups to accomplish programmatic goals.

Conditions of Employment

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• 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.
• 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

To be placed into a Cures position, candidates must meet the following criteria:

1. Scientific, Technical, and Professional Fields

2. Qualified and Outstanding Candidates

a. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the basic requirements defined in the OPM Qualification Standardsas a baseline for comparing experience levels and other candidate attributes for relevant positions.

b. Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.

In order to qualify for this Title 21 Cures position, the candidate(s) must meet the following required qualifications. Please note: Additional education and experience listed that is not indicated as required is preferable and desired. Candidates who do not meet the “desired” criteria will not be excluded from consideration for this position.

Education Requirement:

Candidates must possess the required individual occupational requirements to qualify for the appropriate series applicable to the position.

Education Transcripts

SUBMITTING YOUR TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. A transcript is required to verify educational achievement. Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current FDA employee, you are not exempt from transcript requirements.

FOREIGN EDUCATION: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.

Desired Skills and Experience

An ideal candidate will possess the following:

• Project Management Professional (PMP) certification
• Vaccine development experience

Security Clearance Requirements

Background Investigation/Security Clearance Requirements: 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.

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.

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

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 accommodationsor 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 electronic resume or curriculum vitae (please be sure to clearly define the number of years using month and year training completed, in addition to describing duties performed during that time period), SF50 (if applicable), latest PMAP (if applicable), and letter of interest with “CURES CBER/OVRR/IOD Office Program Manager” in the subject line to: CBERHumanCapital@fda. hhs. gov AND evan.cooney@fda. hhs. gov.Applications will be accepted through June 2, 2023.

Announcement Contact

For questions regarding this Cures position, please contact CBERHumanCapital@fda. hhs. govor evan.cooney@fda. hhs. gov.

Job Type: Full-time

Pay: From $112,015.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Silver Spring, MD 20903: Reliably commute or planning to relocate before starting work (Required)

License/Certification:

• PMP (Preferred)

Work Location: In person

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