Consumer Safety Officer

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 (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.

Duties/Responsibilities

The incumbent serves as the Consumer Safety Officer in the Bioresearch Monitoring (BIMO) Branch (BMB) within the Division of Inspections and Surveillance (DIS) under the Office of Biologics Quality (OCBQ) within CBER. BMB is responsible for coordinating and providing support to the review teams for Investigational New Drug Applications (IND), Investigational Device Exemptions (IDE), Biologics License Applications (BLA), Pre-Market Applications (PMA), and supplements. BMB manages a full range of work within the BIMO program areas for Sponsors/Monitors/Contract Research Organizations (CRO), Sponsor-Investigators, Clinical Investigators, Institutional Review Boards (IRB), and Pre-Clinical Laboratories. BMB coordinates and provides direction to the Office of Inspections and Investigations (OII) field offices for application-driven, directed/for-cause, and surveillance inspections. BMB recommends (based on applicable evidence) and coordinates with the Division and Office management, Office of Chief Counsel (OCC) or Centers as appropriate, the development and administration of potential administrative and legal actions based on complete gathering and analysis of facts, logical, and informed conclusions and practical considerations. BMB works with OII to prepare BIMO inspection work plans and allocate resources for the CBER BIMO inspection programs. BMB manages and tracks data entered into various CBER Data Repository Systems and ensure quality and efficient reporting to these systems.

Specifically, the Consumer Safety Officer will:

• Apply scientific, regulatory, and policy knowledge to analyze facts and develop logical conclusions and recommendations.
• Prepare complex technical inspection assignments of preclinical laboratories, IRBs, clinical investigators, sponsors/monitors/CROs.
• Review and evaluate inspection reports, analyze the evidence collected to determine if policies were violated and information from related BLAs, INDs, IDEs, PMAs or other documents and sources.
• Assess whether the rights, safety, and welfare of human subjects are protected, and whether the data evaluated during the inspection may be considered reliable.
• Determine which sections of the law and regulations appear to have been violated based on analysis of the evidence, assess the level of risk and regulatory significance of the violations.
• Provide technical input to evaluate the chronology of evidence contained in inspectional reports, analytical reports, and summary of case history as reflected in the pertinent files.
• Reconcile and coordinate the facts and opinions on the case available within and outside the Agency.
• Summarize findings and submit substantive recommendations that are usually accepted based on incumbent technical knowledge.
• Independently develop strategies for achieving compliance and initiate appropriate compliance actions.
• Research precedent BIMO cases to ensure that the proposed approach is consistent with past actions.
• Complete inspections by preparing letters or memorandums that require review and concurrence by the Division Director, Office Director, and possibly the Office of the Chief Counsel (OCC).
• Determine appropriateness to pursue enforcement actions, such as issuance Untitled Letters, Warning Letters, letters initiating disqualification proceedings, and coordinates the enforcement action through to final agency approval.
• Manage disqualification actions until completion, requiring interaction with staff in other offices in the Agency.
• Provide guidance, assistance, interpretations, recommendations, and evaluations to CBER employees, OII field offices and investigators, other Centers, Agencies, and Government Units, Industry and Consumers specific to problematic areas of concern within CBER and throughout FDA.
• Provide scientific, legal and policy input to the training program and preparation of compliance programs and guidance for use by center staff and field investigators, in performing BIMO inspections.
• Train and act as a mentor for less experienced Branch staff, both formally and informally.
• Participate in meetings with industry that are directly related to a BIMO enforcement action, as well as, in meetings with OII, other Centers, or other FDA components to discuss cross-cutting issues relevant to the BIMO program.
• Represent BMB, the Division, and the Office in the development of training events for CBER, OII, and other Agency staff.
• May speak at conferences and professional meetings before the regulated industry, clinical investigators, and the medical/scientific community on applicable regulations, guidance, and policies.
• Support the Center’s and Agency’s mission as a partner in special work projects, task groups, or individual assignments, potentially serving as a Project Manager.
• Perform other duties as assigned.

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), a copy of your unofficial transcripts, SF50 (if applicable), latest PMAP (if applicable), and letter of interest with “CURES CBER/OCBQ/DIS/BMB/Consumer Safety Officer” in the subject line to: [email protected]. Applications will be accepted through 11/01/24.

Announcement Contact

For questions regarding this Cures position, please contact [email protected].

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

FDA is an equal opportunity employer.