The OGD Virtual Hiring Event
Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), FDA is excited to announce our first Virtual Hiring Event. You will have the opportunity to meet the Director of the office along with other staff members and learn firsthand about the positions available within OGD. CDER’s Office of Generic Drugs is seeking talented, highly motivated and qualified individuals to help implement the Generic Drug User Fee Amendments of 2012 (GDUFA). This major FDA recruiting initiative is designed to speed access to safe and effective generic drugs to the public, and reduce costs to industry. Within OGD are health care providers, scientists, and many other professionals who strive to meet OGD’s mission, which is to promote and protect public health by overseeing the development and implementation of standards for the safety and effectiveness of generic drugs.
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Office of Compliance, Center for Drug Evaluation and Research, FDA is excited to announce our first Virtual Hiring Event. You will have the opportunity to meet the Director of the office along with other staff members and learn firsthand about the positions available within OC.
CDER’s Office of Compliance is seeking talented healthcare, technical and science professionals to handle complex regulatory and policy work of national scope and significance. The Office of Compliance leads a broad range of programs – including enforcement of drug approval and labeling requirements, pharmacy compounding, Internet and health fraud, drug import and export, current good manufacturing practice, good laboratory and clinical practice, and surveillance of industry adverse event reporting. The objectives is to assure that human drugs are safe, effective, and of high quality.
The Office of Compliance is made up of four Offices, the Office of Scientific Investigations, the Office of Unapproved Drugs and Labeling Compliance, the Office of Manufacturing and Product Quality, and the Office of Drug Security, Integrity and Recalls.
Office of Scientific Investigation (OSI):
OSI’s responsibilities include: developing policies, surveillance activities, and compliance strategies relating to nonclinical and clinical drug product studies, bioequivalence studies, human subject protections, post-market Adverse Drug Experience reporting requirements, Risk Evaluation and Mitigation Strategies, and commitments for Postmarketing Requirements; developing and implementing the Agency's Bioresearch Monitoring Information System for Human Drugs in cooperation with the Office of Regulatory Affairs (ORA) under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, the Food and Drug Amendments Act, other Federal statutes, and applicable regulations; developing, contributing and formalizing regulatory strategies and guidance including CDER Policies, Staff Guidance Manuals, and Compliance Program Guidance Manuals to promote compliance with Good Clinical Practice (GCP) in research, human subject protections, Good Laboratory Practices, Bioequivalence, Risk Evaluation and Mitigation Strategies (REMS), and Adverse Event Reporting surveillance.
Office of Unapproved Drugs and Labeling Compliance (OUDLC):
OUDLC’s responsibilities include: developing policies and compliance strategies for protecting the public health by assuring compliance with the new drug and misbranding requirements of the Federal Food, Drug and Cosmetic Act; and using risk based assessments and strategic enforcement actions to identify and address products that pose the most significant risks to consumers associated with unapproved and misbranded drugs.
Office of Manufacturing and Product Quality (OMPQ):
OMPQ’s responsibilities include: ensuring conformance with the good manufacturing and other anti-adulteration provisions of the Food, Drug, and Cosmetic Act; supporting the development and maintenance of applicable requirements (laws and regulations) by providing compliance assistance to regulated industry and reviewing proposed enforcement actions for technical and legal validity; developing and operating programs for surveillance of the manufacturing industry’s conformance with requirements; and supporting the review and approval of facilities and equipment portions of new drug applications.
Office of Drug Security, Integrity and Recalls (ODSIR):
ODSIR’s responsibilities include: developing policies and compliance strategies for protecting the public health by assuring drug product integrity and supply chain security; coordinating evaluation and classification of drug recalls and provides Center coordination with field offices for implementation of recalls and monitoring resolution of related compliance issues; ensuring integrity of imported drug products by assuring compliance with applicable legal requirements; serving as the main liaison in the Office of Compliance for coordinating compliance issues with the Drug Shortage program; and providing central coordination in the Office of Compliance for obtaining and evaluating Health Hazard Evaluations.