Public Health Analyst (Band C)

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.

• Provides expert guidance to OMQ Management regarding regulatory programs and compliance operations by furnishing critical information that will guide the planning, coordination, and evaluation of major OMQ public health program initiatives concerning human drugs, compliance, drug quality, quality management systems, core competency development, outreach, and stakeholder (i.e., other CDER offices, FDA, pharma industry, academia, small business) engagement.
• Performs duties related to major OMQ programs and activities (e.g., current good manufacturing practices (CGMPs) compliance, drug quality, regulatory action and enforcement, stakeholder outreach and operations development related to human drugs). Program areas include compliance and enforcement of CGMPs, drug quality, quality management systems, core competency development, outreach and stakeholder engagement, process and program innovation and improvements.
• Coordinates background information and data used for program operations, outreach by OMQ to stakeholders and analysis of OMQ outputs in the form of metrics (i.e., graphs, reports, charts, performance indicators and quality systems). Tracks and reports on project and program status, program development activities and identifies potential adverse impacts and recommends solutions.
• Prepares correspondence and advises other divisions and offices in the Center on procedures and methods for dealing with requests for information related to human drugs. Prepares various presentations, policies and procedures, reports, and correspondence that includes status reports to senior leadership in CDER or FDA Provides input on critical standing reports that outline accomplishments and performance goals for programs such as Concept of Operations and GDUFA III and efficiently handle ad hoc requests.

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 C” 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.

FDA is an equal opportunity employer.