Project Manager I

Cognizance Technologies, LLC | Full time Silver Spring, United States | Posted on 08/07/2026 The purpose of this requirement is to acquire both project and regulatory project management support services for the Office of Generic Drug User Fee Amendments (GDUFA) regulatory science and research program. The requirement is to provide project management support for ongoing regulatory and research related tasks including Pre-Abbreviated New Drug Application (Pre-ANDA) program activities, and Interdisciplinary Scientists and SMEs to support the development of product-specific guidance documents by: Performing scientific analyses and assessing matters relevant to the development of generic products; developing pertinent and useful research goals to support product-specific internal review processes and regulatory decision-making; writing and revising product-specific guidance documents; and helping achieve other goals relevant to matters that the FDA Office of Generic Drugs has committed to address as part of the Generic Drug User Fee Amendments (GDUFA) Program as related to product-specific guidance development. TheProject Manager I will support the Office of Generic Drug Policy's essentialworkstreams by triaging, budgeting, tracking, provide project oversight and archiving OGD work projects bybuilding and applying working knowledge of generic drug regulation and OGDP'sIT systems. This position ensures the continuity of OGDP's regulatory reviewsupport consistent with the agency's GDUFA and PDUFA commitments. Requirements Required Knowledge, Skills, and Abilities Demonstrated experience coordinating research projects, timelines, and documentation across multiple stakeholders. Strong budgeting and financial management background, including experience monitoring project costs against timelines and resource plans. Strong IT skills, including proficiency with Microsoft Office, SharePoint, and database systems;ability to learn and train others on Qdocs, Platform, and Nexus. Excellent written and oral communication skills, including meeting documentation and minute-taking. Strong organizational skills, with the ability to monitor multiple project timelines simultaneously. Ability to coordinate effectively with internal and external collaborators. Hold a Project Management Professional (PMP) certification or equivalent demonstrated experience. Have experience supporting federal government program management or regulatory agency initiatives. Preferable to have familiarity with FDA user fee programs, pharmaceutical regulatory processes, or comparable health policy environments (preferred). Be available to attend meetings and respond to FDA communications during core business hours. Project managers should demonstrate experience with budget tracking and spending actions. Demonstrated experience triaging, tracking, and archiving high volumes of work projects under short deadlines. PPO/HMO Health Plan (includes medical, dental, and vision) #J-18808-Ljbffr Cognizance Technologies, LLC