Science Disclosure Analyst

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.

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 3/25/24. 

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.