FDA AD-0401-Bands Science Disclosure Analyst Instructions

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 Communications Outreach and Development (OCOD)
Division of Disclosure and Oversight Management (DDOM)

AD-0401-Bands Science Disclosure Analyst

Application Period: 5/13/24 – 5/29/24
Area of Consideration: 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: Science Disclosure Analyst
Multiple selections can be made from this announcement
Location(s): White Oak Campus, Silver Spring, MD.
Work Schedule: Full Time
Cures Band(s): Bands A/B
Series: 0401
Salary: Starting at $82,764
Telework Eligible: Yes
Full Performance Band Level:
Band A FPBL: Band B
Band B FPBL: Band B
Travel Requirements: 25% or less
Bargaining Unit: 3591

Note: 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. Additional information on 21st Century Cures Act can be found here:
21st Century Cures Act Information

Introduction

The Food and Drug Administration is the federal agency responsible for protecting the public health by helping to ensure the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by helping to ensure the safety of our nation’s food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. FDA’s programs are national in scope and effect, and the agency’s activities have a direct and significant impact on multi-billion-dollar industries, in addition to protecting the health and safety of American Consumers. The work of the Agency is carried out by a staff of more than 18,000 scientists, physicians, regulatory and other personnel stationed throughout the United States.
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 public health through the regulation of biological and related products including blood, vaccines, allergenics, human tissues, and cellular and gene therapies. CBER protects and advances the public health by helping to ensure that biological products are safe, pure, and potent.
CBER also provides the public with information to promote the safe and appropriate use of biological products.

Duties/Responsibilities

The incumbent serves as a Science Disclosure Analyst within the Division of Disclosure and Oversight Management (DDOM) under the Office of Communication Outreach and Development (OCOD). This position reports to the DDOM Supervisory Science Disclosure Analyst. The incumbent uses scientific knowledge to implement and ensure compliance of statutory requirements for the public release of information about technical scientific information specific to applications for an array of biological products, both investigational and licensed, including allergenic, blood and blood components, medical devices and tests, gene therapy, human tissues and cellular products, vaccines, and xenotransplantation products.

Specifically, the Science Disclosure Analyst will:

• Develop segments of the Center’s scientific disclosure analysis activities and review, under the direction of higher graded staff, important and sensitive Center responses to requests for Center records received under the Freedom of Information Act (FOIA) as amended.
• Review requests for scientific disclosure analysis of Center records including, but not limited to, web posting of records required by the Food and Drug Administration Amendments Act of 2007 (FDAAA), other statutes, Center policy, or records posted for advisory committee meetings and scientific disclosure analysis of Center records for sharing with international counterparts.
• Conduct the scientific disclosure analysis on records rich in advanced scientific content and apply the understanding of scientific principles, content, and context related to drug and biological products to make consistent disclosure determinations.
• Prepare Center draft recommendations for denials of requested information, which is exempt from disclosure.
• Provide advice on disclosure of advisory committee records and records for sharing with international counterparts; such recommendations include sufficient justification and all available evidence to support the recommendations.
• Provide guidance and direction to Center personnel involved with handling responses to Freedom of Information (FOI) requests and other disclosure activities. This requires an understanding of the FOIA, the Privacy Act (PA), DHHS’s and FDA’s implementing regulations and always requires that the incumbent keep abreast of all changes to the statutes and regulations to ensure Center compliance.
• Be aware of current developments in the Center to correctly review and analyze records for disclosure.
• Have sensitivity to emerging problems that are reflected in disclosure inquiries and assists in developing recommendations for Center action to cope with these problems. These recommendations are directed to the affected units, within the Center, through the division management. The incumbent ensures appropriate consideration and referral of such problems.
• Work with representatives from the Office of Chief Counsel in the preparation of background and testimony of FDA officials in court cases on defending FDA’s position on the disclosure of requested information.

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 Standards as 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. Please use the following link to determine the series for which you qualify: OPM Occupational Series Qualification Requirements

Desired Professional Experience:

• General knowledge of the Food, Drug and Cosmetic Act, the Public Health Service Act, and the implementing regulations and policies;
• Experience applying standards, regulations or statues to scientifically rich content;
• Knowledge of biological sciences related to the products regulated by CBER programs (that is, vaccines, blood, blood products, HCT/P human cells, tissues and cellular and tissue-based products) which includes fields such as biology, microbiology, medical technology, medical laboratory sciences, hematology, immunology, and/or virology, to conduct scientific disclosure analysis of Center records;
• Interpersonal skills sufficient to organize and coordinate thorough, systematic, and professional projects to meet the established and unanticipated needs of the CBER offices, Office of the Commissioner, other Centers, HHS, and other Agencies; and
• Ability to effectively communicate orally and in writing.

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.
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. 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/aboutfda/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: 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 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), copy of unofficial transcript (s) and letter of interest with “CURES CBER/OCOD/DDOM Science Disclosure Analyst” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through 5/29/24.
Announcement Contact: For questions regarding this Cures position, please contact CBERHumanCapital@fda.hhs.gov.
The Department of Health and Human Services is an equal opportunity employer with a smoke-free environment.
FDA is an equal opportunity employer.

References

• HHS Accessibility & Section 508 | HHS.gov

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