Public Health Analyst (Band B)

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 Drug Evaluation and Research (CDER) is responsible for regulating prescription drugs, including new drugs, generic drugs, biological products and biosimilars as well as over‐the‐counter drugs (OTC).

The mission of the Office of Compliance (OC) is to shield patients from poor quality, unsafe and ineffective drugs through proactive compliance strategies and risk-based enforcement actions. CDER OC strives to be a model of efficiency, innovation, and operational excellence. Guided by law and science, the Office makes strategic and risk-based decisions, communicates clearly with all stakeholders, fosters global collaboration, promotes voluntary compliance, and takes decisive action.

The function of the Office of Manufacturing Quality (OMQ) is to develop and implement compliance and enforcement policies and actions to protect patients from firms whose quality standards and practices may pose a significant risk to public health.

Duties/Responsibilities

As a Public Health Analyst, the incumbent consults on public health analytical matters related to the program operations of human drugs and Current Good Manufacturing Practices (CGMPs) in the Office of Manufacturing Quality (OMQ). In this capacity, the incumbent assists senior analysts and other OMQ employees in identifying program areas which warrant further study or improvements and draft reports to ensure optimum operating efficiency and resource utilization.

• Analyzes and utilizes incoming public health information from inspections, incidents, adverse events, drug shortages, drug quality information to advance the public health mission of the organization, evaluates the public health impact of OMQ programs, and analyzes this data and other information to make data driven decisions affecting the public health mission of the agency. Identifies areas which warrant further study or improvements and prepares reports to ensure optimum operating efficiency and resource utilization.
• Provides public health analytical support (i.e., communication with external stakeholder groups, data analytics, research and/or special projects related to compliance/enforcement actions) to the Office Director, Deputy Directors, and Division Directors regarding regulatory and compliance operations support. Furnishes leadership with critical information that is received by the agency, Center or office from regulated industry, external stakeholders or the public or the planning, coordination, and evaluation of major OMQ public health program initiatives concerning human drug compliance, drug quality, outreach, regulatory programs, and stakeholder engagement.
• Prepares correspondence and provides insight to other divisions and offices in the Center on procedures and methods for dealing with information related to human drugs. Provides input on office key performance indicator standing reports, either at the request of OMQ management, other Center management or are part of an agency directive or mandate (i.e., Generic Drug User Fee Act- GDUFA or the CDER/ORA Concept of Operations) and efficiently handles ad- hoc requests.
• Participates in meetings with the OMQ leadership and others within the office on problems related to regulatory compliance and program management issues under evaluation. Maintains continuing liaison with other organizations within CDER (i.e., Office of Pharmaceutical Quality, Office of Generic Drugs), the Agency and the regulated industry. Provides necessary support in the coordination, planning, consultations, opinions, and endorsements. Provides logistical support to agency taskforces that have national and international impact.

Supervisory Responsibilities: N/A

How to Apply

Submit a curriculum vitae and cover letter describing why you are uniquely qualified for this position, including how you possess the desired experience and qualifications identified above by October 15, 2024 to CDER-OC-OMQ-RECRUITMENT@fda.hhs.gov.

Candidate resumes may be shared with hiring officials within CDER with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”.

Please include “Public Health Analyst- Band B” in the subject line of the email.

Announcement Contact

For questions regarding this Cures position, please contact CDER OC PMAS at CDER-OC-OMQ-RECRUITMENT@fda.hhs.gov.

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