Project Manager I

Cognizance Technologies, LLC; Silver Spring (MD); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

PPO/HMO Health Plan (includes medical,

Job summary

Cognizance Technologies, LLC in Silver Spring, MD is seeking a Project Manager I to provide project and regulatory program support for GDUFA-related activities, including Pre-ANDA tasks and collaboration with interdisciplinary scientists.

The role emphasizes budgeting, tracking, archiving, and coordinating with internal and external stakeholders, with PMP certification or equivalent experience preferred, and familiarity with FDA programs.

Qualifications

• Experience coordinating research projects, timelines, and documentation across multiple stakeholders.
• Strong budgeting and financial management background with tracking against timelines and resource plans.
• Proficiency with Microsoft Office, SharePoint, and database systems; ability to learn Qdocs, Platform, and Nexus.
• Excellent written and verbal communication, including meeting minutes.
• Strong organizational skills to monitor multiple project timelines simultaneously.
• Ability to coordinate with internal and external collaborators.
• Hold a Project Management Professional (PMP) certification or equivalent experience.
• Experience supporting federal government program management or regulatory agency initiatives.
• Familiarity with FDA user fee programs or pharmaceutical regulatory processes preferred.
• Available to attend meetings and respond to FDA communications during core business hours.
• Demonstrated experience triaging, tracking, and archiving high volumes of work under short deadlines.

Responsibilities

• Triaging, tracking, and archiving high volumes of work projects.
• Provide project oversight, budgeting, and timeline management.
• Coordinate across internal and external stakeholders.
• Support development of product-specific guidance within OGDP.
• Assist in preparing documentation for regulatory reviews and decisions.
• Ensure continuity of regulatory review support aligned with GDUFA commitments.

Skills

Project coordination

Budget management

MS Office

SharePoint

Databases

Qdocs

Platform

Nexus

Clear communication

Stakeholder coordination

PMI-PMP certification

Federal government programs

FDA program familiarity

Meeting management

Budget tracking

Archiving

Tools

Qdocs

Platform

Nexus

Job description

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)