Global Project Manager

Global Project Manager:
Project Manager / Drug / Combination Products Medical Device / Pharmaceutical / Biopharmaceutical / Smartsheet / 21

CFR
820.30 / Design Control requirements / PMP / English / German Background:

We are looking for a Principal Project Manager (PM) to manage a range of projects, based on their stage and complexity. This role encompasses a variety of assignments including development pipeline, line extensions, post-approval, technology, and continuous improvement initiatives. The PM will work independently, effectively prioritizing and managing workload to meet team goals with limited direction. The role includes flexibility for global time zone interactions and occasional travel to external partners for collaboration and planning activities.

The Perfect Candidate holds a Bachelor's degree in Engineering or a related field, supported by 8 to 11 years of professional experience, including a minimum of 5 years within the medical device, pharmaceutical, or biopharmaceutical sectors. They should possess significant expertise in managing drug or medical device development and commercialization projects, with a focus on combination products and vendor collaboration. Proficiency in industry-standard project management tools, such as Microsoft Project, Smartsheet, and Google Suite, is required, alongside a thorough understanding of 21

CFR
820.30 design control requirements. A PMP certification is considered a valuable asset for this role. Furthermore, the candidate should demonstrate the ability to manage complex projects independently within a fast-paced environment and possess excellent communication and relationship-building skills. Fluency in English is required, while proficiency in German, Japanese, or Danish is advantageous.

In collaboration with the Technical Development Team Lead (TDTL) & Device Team Leader (DTL), the PM will translate device strategy into actionable plans, focusing on three key areas:

Planning:
Define "inspection ready" Design & Development Plans

Execution:
Drive team activities to meet project and design control deliverables

Team Dynamics:
Ensure effective communication and facilitate team performance in a regulated environment using various processes and tools for planning, communication, budget, schedule, compliance, and risk management

Maintains full understanding of program milestones for the Core, Lifecycle, Technical Development and associated teams and links them to the Device Team plan

Effectively applies PM best practices and utilizes tools for planning, communication, team building, collaboration, decision-making, issue & risk management, lessons learned, knowledge management and budget tracking

Develops & updates Design & Development Plan and establishes contingency plans as needed

Ensures transparent communication of key team information and escalates issues as appropriate

Establishes positive team dynamics through team building

Promotes collaborative environment across team members

Facilitates efficient decision-making and issue resolution

Identifies team risks and mitigation plans

Manages project scope and facilitate necessary changes

Facilitates project plan development and execution, and monitor the project schedule

Integrates deliverables with other teams linked to the product

Ensures effective team dynamics and positive team environments

Anticipates and manage risks with proactive contingency plans

Facilitates risk management process and issue resolution

Assesses Team dynamics and leads team building activities to enable and sustain a high performing team environment

Establishes relationships and network with other stakeholder Teams and PMs

Develops and adapts project communication tools to drive awareness of project progress and risks across stakeholders including external collaborators (e.g. dashboard)

Acts as Device Team Leader back-up for Team communication as required

Liaises with other Teams to manage cross-functional activities and issues and risks

Facilitate effective team meetings with clear outcomes and follow-up actions

Forecast and monitor team resources and project costs

Establishes centralized Team access to all relevant project information

Manages Team uncontrolled document repository (e.g. Project History File)

Conducts lessons learned exercises during project execution and share outcomes to a broader audience

• Bachelor's degree in Engineering or a related field.
• 8 to 11 years of experience, with at least 5 years in a relevant industry, preferably within a global medical device, pharmaceutical, or biopharmaceutical company
• Experience in project management in drug and/or medical device development and commercialization, particularly with combination products
• Proficiency in Project Management best practices and software (Microsoft…