Project Manager

Summary of the Role

Join a large biotech pharmaceutical leader as a Project Manager supporting global medical device and combination product development programs from early stages through commercialization. This role will help drive project execution, coordinate cross-functional activities, maintain integrated project plans, and support process improvements in a regulated environment. The ideal candidate is highly organized, proactive, and comfortable working across engineering, quality, regulatory, clinical, manufacturing, supply chain, and external partner teams to keep programs aligned, visible, and moving forward.

Key Responsibilities

• Facilitate cross-functional coordination for medical device and combination product development programs
• Develop and maintain integrated project plans, timelines, milestone trackers, action logs, and reporting tools
• Partner with engineering, quality, regulatory, clinical, manufacturing, supply chain, and other teams to support aligned execution
• Organize and support core team meetings, program reviews, and project working sessions
• Prepare meeting agendas, document decisions, track action items, and follow up on next steps
• Monitor project status against timelines, milestones, and key deliverables
• Escalate risks, delays, dependencies, or issues that may impact project execution
• Create and update project dashboards, status reports, presentations, and milestone review materials
• Maintain program documentation to support design reviews, phase gates, launch readiness, and regulatory readiness
• Support risk, issue, assumption, and change tracking to maintain program visibility
• Coordinate with external suppliers and partners as applicable
• Contribute to process improvement initiatives for project management practices, templates, and team routines

Qualifications

• Experience in project management roles within large, matrixed organizations
• Strong organizational, communication, and follow-through skills
• Ability to coordinate activities across diverse cross-functional teams
• Experience maintaining project plans, schedules, trackers, milestones, risks, and status reports
• Strong attention to detail and ability to manage multiple priorities
• Ability to prepare clear meeting agendas, notes, action logs, and leadership-ready materials
• Experience supporting project execution in a regulated environment
• Ability to identify risks, escalate issues, and support timely decision-making
• Proficiency in project planning, tracking, reporting, and documentation management

Preferred

• Experience supporting medical product, medical device, combination product, or technical development programs
• Experience working with design control, quality systems, launch readiness, or regulatory milestone activities
• Experience coordinating with external suppliers or partners

Top 3 Must Have Skills

• Project planning and tracking, including integrated project plans, schedules, milestones, risks, and reporting
• Cross-functional coordination and communication across multiple disciplines in a matrixed environment
• Strong organization and follow-through on multiple priorities, action items, and documentation

Day-to-Day Responsibilities

• Update and maintain project plans, trackers, action logs, and milestone schedules
• Coordinate meetings across functional teams and prepare agendas
• Document decisions, actions, risks, dependencies, and follow-up items
• Monitor project progress and proactively identify issues or delays
• Escalate project risks and roadblocks as needed
• Prepare status updates, dashboards, presentations, and leadership materials
• Maintain program documentation for design reviews, phase gates, launch activities, and regulatory readiness
• Coordinate activities with suppliers and partners that impact program deliverables
• Support compliance efforts related to design control, quality systems, and regulatory standards
• Improve project management templates, processes, routines, and team operating practices