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Clinical Program Manager (Clinical Compliance and Regulatory)
Clinical Program Manager (Clinical Compliance and Regulatory)-March 2024
Mar 29, 2026
About Clinical Program Manager (Clinical Compliance and Regulatory)

  Overview

  The Administration for Strategic Preparedness and Response (ASPR) is a public health preparedness and emergency response organization in the Office of the Secretary at the United States Department of Health and Human Services. ASPR was created under the Pandemic and All Hazards Preparedness Act in the wake of Hurricane Katrina to lead the nation in preventing, preparing for, and responding to the adverse health effects of public health emergencies and disasters.

  Required Tasks and Responsibilities:

  Coordinate internal resources to drive successful completion of projects in support of ASPRs mission using knowledge and expertise in project and portfolio management.Ensure that all projects are delivered on-time, within scope, and within budget.Assist in the definition of project scope and objectives, involving all relevant stakeholders and ensuring technical feasibility.Develop a detailed project/work plan to monitor and track progress.Measure project performance using appropriate tools and techniques.Provide program and project management support and subject matter expertise as it relates to the successful development, manufacturing, licensure, and distribution of drugs, medical devices and/or products, biologics, therapeutics, and other MCMs as required.Responsible for all aspects of program performance (i.e., technical, contractual, administrative, financial, etc.).Provide leadership to the technical and acquisition teams, ensure conformance to performance requirements, and assist in the overall direction to all project level activities and personnel.Provide technical and appropriateness review of program reports and documents prepared for senior leadership.Conduct program research/analysis and develop programmatic evaluative documents, as required.Conduct other tasks as assigned in keeping with the scope of this TO.Be proficient with all MS Office products, Adobe Acrobat, and Smartsheet.Experience and Qualification Requirements

  5 years of relevant industry experience as mid-level project manager.Possess excellent written and verbal communication skills.Experience within the pharmaceutical or healthcare industries is strongly desired, with consideration given to experience leading early stage and clinical projects and teams through to successful licensure.Relevant experience supporting the successful regulatory clearance of a drug, medical device and/or product, biologic, or therapeutic through the FDA is strongly preferred.PMP certification is desired.

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