Senior Project Manager

A Brief Overview

As a Senior Project Manager, you'll play a pivotal role in bringing new products to the market to make a positive impact on our customers. The Senior Project Manager reports to the Sr. Director of Injectables, Cosmeceuticals, Early Development | PMO and works within our Project Management team in Raleigh, NC. This person will lead and support new/ongoing development projects within the Injectables franchise and Early Development to achieve project milestones, while ensuring the work meets Design Control requirements.

What You Will Do

• Lead, guide, manage, and mentor a team of internal and external cross functional resources to deliver project milestones supporting regulatory submissions
• Plan and coordinate all project team activities, translating strategy into cross-functional integrated project plans
• Prioritize project tasks by identifying the critical path, removing obstacles, and resolving issues or conflicts
• Define, monitor, and manage project budgets, including quarterly forecasting and monthly budget reporting
• Assist with contracting process for outsourced activities including review and approval of contracts
• Anticipate and manage project risks and issues, providing mitigation and corrective action strategies
• Manage resources within a project team and negotiate with functional groups for personnel acquisition
• Facilitate project team meetings, set agendas, publish minutes, follow up on action items, and maintain project documentation
• Develop presentations and communicate project status against key milestones and budget for stakeholders
• Lead ad-hoc projects and multidisciplinary task forces for process development and refinement
• Motivate and mentor the team to achieve project objectives

Minimum Requirements

• Bachelor of Science (B.S.) in Scientific, Engineering, or Health Care disciplines
• 7-10 years experience in pharma, medical device product development
• 5+ years experience in the role of Project Manager/Leader of cross-functional projects

Preferred Qualifications

• Master's Degree in Scientific, Engineering, or Health Care disciplines
• Doctorate/PhD in Scientific, Engineering, or Health Care disciplines
• Experience working with medical devices, preferably Class III devices
• Good working knowledge of regulatory filing requirements for medical device product development
• Demonstrated ability to monitor, manage, and grow diverse external partnerships (CMO management)
• Professional Project Management related certification (PMP, IPMA, or similar)
• Experience with early development / innovation programs

Technical & Functional Skills

• Thorough understanding of Project Management practices, principles, and tools for medical device/drug/consumer product development projects
• Good experience with Design Control, ISO 13485, ISO 14971 and other applicable standards
• Demonstrated project management skills in leading multi-disciplinary, multi-regional teams
• Knowledge across the entire product development process from concept through design, design transfer, regulatory submission and approval, and launch
• Expert knowledge of MS Excel, Outlook, PowerPoint, Word and proficient in MS Project
• Proven experience managing multiple projects and/or programs concurrently
• Demonstrated proficiency managing rapidly changing priorities and aggressive timelines
• Strong interpersonal, leadership, self-starting, oral/written communication skills
• Advanced skills as a team leader, motivator, and in conflict resolution
• Experience supporting or leading early development and/or innovation programs