|
Summary:
The Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective; that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe; and that all such products marketed in the U.S. are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated.
The mission of the Center for Biologics Evaluation and Research (CBER) 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.
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
Duties:
The incumbent serves as a Consumer Safety Officer (CSO) in the Program Surveillance Branch (PSB) of the Division of Inspections and Surveillance (DIS) in the Office of Compliance and Biologics Quality (OCBQ). The Consumer Safety Officer is required to bring professional competence to bear in analyzing significant facts and developing logical conclusions regarding the regulation of biological products under Public Health Service Act and the federal regulations at Title 21, Code of Federal Regulations, Part 600 and part 1271, and Cosmetic Act and federal regulations relating to current good manufacturing practices (CGMP’s) for finished pharmaceuticals and medical devices, as well as federal regulations relating to current good tissue practices (CGTP’s).
Specifically, the Consumer Safety Officer will:
Coordinate meetings and manage the process in the preparation of comprehensive surveillance and compliance programs.
Participate in work groups in the preparation of guidance documents concerning inspectional procedures and compliance policies.
Provide regulatory guidance to employees and investigators on compliance related issues regarding reporting requirements for biological products.
Review regulatory reports to facilitate decision making processes.
Assess biological product quality reports to determine appropriate follow-up which may involve recommending inspections or recommending products for possible recall classification.
Prepare written annual summary regarding data collected from reports submitted to the Agency concerning licensed biological products.
Develop the Agency position in response to requests or advisory opinions from the regulated industry, covering the full range of subject matter within the assigned work area.
Discuss issues with scientific and medical personnel within FDA to establish precedents for action or to identify and recommend an FDA position when policy is nonexistent or not applicable.
Draw conclusions and recommend a specific reply to inquiries, designating new policy interpretations and the need for new or revised policy developed by CBER.
Serve as a contact point for inquiries from both CBER and investigators for guidance concerning appropriate actions against non-complying license and/or unlicensed biological product establishments in accordance with compliance programs and Agency/Center policy.
Participate in meetings with CBER staff and management for the purpose of discussing and offering solutions to industry problems, trends, violations, and policy.
How to Apply:
Please submit electronic resume or curriculum vitae (for each position held, please be sure to clearly define the number of years by month and year, all completed trainings, and clearly describe duties and accomplishments). Please also submit SF50 (if applicable), latest PMAP (if applicable), unofficial transcripts, Foreign Credit Evaluation (if applicable), copy of your active medical license/s (if applicable), copy of your board certification/s (if applicable), and letter of interest (Word or PDF) with “Title 21 CBER/OCBQ/DIS/PSB Consumer Safety Officer” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through 11/18/24.
Announcement Contact:
For questions regarding this Title 21 (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.
|
