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: Provide oversight, evaluation and coordinate foreign inspection work for the operating investigators while they are actually participating in the program conducting international inspections. Participate as a subject matter specialist in the onsite evaluation of field activities. Identify areas which warrant further study and attention by the field to ensure optimum operating efficiency and resource utilization. Assist in the planning, establishing, directing, and implementing of the International Inspection Programs. Assist the Branch Chief in performing appraisals and evaluations on the overall effectiveness of the international inspection programs and develop new concepts as needed. Assures that the administrative elements of the program are met. Serve as the international investigation and inspection expert in one or more of the following disciplines: drugs, devices, biologics, bioresearch monitoring (BIMO), and tobacco products. Job Requirements: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice. Must be able to obtain and maintain a valid driver's license. You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise. All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. All employees must pass a security investigation. 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-12 grade level or higher. Job Details: Company: FDA Vacancy Type: Full Time Job Location: New York, NY, US Application Deadline: N/A Apply Here careers-trivia.com
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