Project Manager (PM)

Job Title:"Project Manager"
Location: Remote
Work Authorization: USC
Duration: Full - Time

Position Summary

The Project Manager (PM) will provide overall project leadership, coordination, and accountability for FDA CDER software development, COTS implementation, and AI-enabled technology initiatives. The PM will be responsible for successful execution of contractual scope, schedule, quality, resources, risks, deliverables, stakeholder expectations, and performance commitments while ensuring alignment with FDA and federal IT governance requirements.

Key Responsibilities

Lead day-to-day project execution for COTS platform implementation, software development, modernization, and AI-enabled solutions, ensuring alignment with contractual requirements and stakeholder expectations..

Manage integrated scope, schedule, staffing, resources, risks, issues, dependencies, deliverables, and performance metrics across project workstreams..

Coordinate implementation and operational support for FDA CDER applications, including Computerized Labeling Assessment Tool (CLAT) activities, as applicable..

Lead Agile/EPLC planning, requirements management and prioritization, sprint/release coordination, change and configuration management, and production readiness..

Manage project plans, action items, assignments, milestones, and dependencies to ensure timely delivery and early identification of potential schedule or performance risks..

Oversee weekly and monthly status reporting, financial and resource reporting, risk/issue tracking, performance metrics, and corrective actions..

Serve as a primary coordination point among FDA stakeholders, CDER service teams, technical teams, subcontractors, vendors, and other project participants..

Manage staffing, workload, and surge requirements and proactively adjust resources based on project priorities and Government requirements..

Ensure development and maintenance of SOPs, project documentation, knowledge-transfer materials, decision logs, and transition artifacts to support operational continuity..

Drive continuous improvement through measurable improvements in delivery quality, automation, cycle time, system reliability, operational efficiency, and customer experience..

Ensure project activities comply with applicable FDA/HHS security, privacy, Section 508, SDLC/EPLC, configuration-management, and quality requirements..

Minimum Qualifications

Demonstrated experience managing complex federal IT software development, modernization, COTS implementation, AI/ML, data management, and/or production-support projects, preferably within FDA, HHS, or another federal health agency..

Strong knowledge of project/program management, Agile delivery, SDLC/EPLC, risk and issue management, quality management, change management, and federal IT governance..

Experience leading multidisciplinary teams consisting of project management, business analysis, software engineering, data, AI/ML, cybersecurity, quality assurance, and operational support personnel..

Demonstrated ability to manage Government stakeholders, competing priorities, project dependencies, deliverables, and performance commitments..

Excellent written, verbal, executive-level, and Government-facing communication skills..

PMP or equivalent project/program management certification preferred..

Bachelor's degree in Information Technology, Computer Science, Engineering, Life Sciences, Business, or a related discipline; advanced degree preferred..