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 - to make them live better, feel better and look better. 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. The role requires excellent Project Management skills, including budget management; a good understanding of medical device Design Control procedures/requirements; and close collaboration with other cross functional team members (Product Development, Clinical Science & Operations, Regulatory Affairs, Quality, Product Safety, Marketing, and Medical Affairs) within Merz, external suppliers and consulting partners. The ideal candidate will have a thorough understanding of and experience practicing Project Management practices, principles, and tools applied to medical device projects. In addition, the candidate should have strong problem solving and communication skills with the drive and hands-on leadership qualities needed to deliver on challenging project goals.

What You Will Do

• Project Planning:
  
  • Effectively lead, guide, manage, and mentor a team of internal and external cross functional resources to deliver the set project milestones to support the required regulatory submissions.
  • Responsible for the planning and coordination of all project team activities, translating strategy into cross-functional integrated project plans.
  • Prioritize the project tasks by identifying the critical path, remove any obstacles or barriers, resolve issues or conflicts to progress the project.
• Budget Management:
  
  • Define, monitor, and manage project budgets, including quarterly forecasting and monthly budget reporting.
  • Assist, as needed, the respective functional team member with contracting process for outsourced activities including review and approval of the contract as necessary according to the approved project budget
• Risk Management:
  
  • Anticipate and manage project risks and issues, and provide specific mitigation and corrective action strategies.
• Resource Management:
  
  • Manage resources within a project team, when needed, negotiate with respective functional groups for the acquisition of required personnel for the project.
• Communication:
  
  • Facilitate project team meetings, set agendas, publish meeting minutes, follow-up on action items, and maintain required project documentation.
  • Develop presentations and communicate project status against key project milestones and budget for a broad set of stakeholders.
• Further Tasks:
  
  • Lead ad-hoc projects and/or multidisciplinary task forces for ongoing development and/or refining of processes as needed.
  • Motivate and mentor the team to achieve set project objectives.

Minimum Requirements

• Bachelor of Science (B.S.) In Scientific, Engineering, or Heath 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 Heath Care disciplines
• Doctorate/PhD In Scientific, Engineering, or Heath Care disciplines
• Experience working with medical devices, preferably Class III devices.
• Good working knowledge of regulatory filing requirements as they pertain to 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
• Experience working with Medical Devices, Class III preferred.
• Demonstrated project management skills in leading multi-disciplinary, multi-regional teams to meet project goals
• Knowledge across the entire product development process from concept phase through design and development, 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
• Good working knowledge of regulatory filing requirements as they pertain to medical device product development
• Demonstrated proficiency managing rapidly changing priorities and aggressive timelines
• Demonstrated ability to monitor, manage, and grow diverse external partnerships (CMO management)
• Demonstrate strong interpersonal, leadership, self-starting, oral/written communication skills
• Demonstrate advanced skills as a team leader, motivator, and in conflict resolution
• Demonstrated experience supporting or leading early development and/or innovation programs, with the ability to navigate high levels of technical and strategic uncertainty, evaluate emerging opportunities, and translate early-stage concepts into structured development plans and actionable next steps.