Job Description: This position is located in the Office of Pharmaceutical Quality Operations (OPQO), Office of Medical Products and Tobacco Operations (OMPTO), Office of Regulatory Affairs (ORA), Food and Drug Administration (FDA), Department of Health and Human Services (DHHS) and will serve as a Program Expert. The Office oversees program directors in the coordination, interpretation and evaluation of the Agency's overall field inspections and compliance efforts in the area of pharmaceutical products. Job Responsibilities: Maintain contacts with federal, state and local officials, trade and cooperative organizations, CDER, CVM, OGPS, and industry in an effort to achieve and maintain a uniform approach to resolution of problems in the pharmaceutical industries. Develop new inspection programs, revisions, or guides and/or manuals and revisions to compliance programs. Implement processes to streamline receipt of information in ORA headquarters to ensure inspectional consistency and effective information sharing between ORA, CDER, CVM and OGPS. Serve as a program expert who provides inspectional, investigational and technical advice and assistance to headquarters, field service, and foreign offices to accomplish compliance objectives. Identify national/international training needs in pharmaceutical areas for federal, state, and local regulatory agencies, the industry, and consumers. Job Requirements: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If you are applying as a current Federal employee, you must meet the time-in-grade requirements described in the Qualifications section, generally, 52-weeks of comparable experience at the next lowest grade. You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise. All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption. Qualification & Experience: Applicants must have 52 weeks at the GS-13 or higher. Job Details: Company: FDA Vacancy Type: Full Time Job Location: Washington, DC, US Application Deadline: N/A Apply Here careers-trivia.com
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