The Food and Drug Administration (FDA) is composed of many integral parts that must function and integrate to protect the public health.  The Center for Drug Evaluation and Research (CDER) is a division within the FDA that monitors most drugs as defined in the Food, Drug and Cosmetic Act.  Within CDER, the mission of the Office of Compliance/Office of Manufacturing Quality (OC/OMQ) is to protect the public health through strategies and actions that minimize consumer exposure to unsafe, ineffective, and poor quality drugs.  Project Managers (PMs) serve as either the regulatory or business process liaisons between the clinical, scientific, legal and other disciplines both internal and external to the FDA.  The FDA perspective on the critical role of the PM will detail practical examples of application of skills, knowledge, tools and techniques being used to meet the needs and expectation of stakeholders.  For example, PMs manage the process for regulatory meetings with industry on compliance issues that are cross-cutting among multiple functions and offices.  Regulatory meetings are high visibility efforts which require collaboration, organization, scientific consults and policy papers, to meet established timeframes and deadlines.  PMs coordinate with team members and other offices within the FDA to develop an agenda, timeline, committee questions, and background material.  As collaborative individuals, PMs are required to work effectively across all organizational levels at the FDA and manage project or program lifecycle quality risks.  They recognize the need and develop new approaches to solve critical problems and prioritize projects with competing deadlines.  Moreover, PMs have a solid knowledge of the office infrastructure, process, and can communicate clearly and effectively.<br/>

Chemist as a project management professional at the FDA

251st National Meeting (2016)

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