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Job Title: Engineering (Medical Device) / Clinical / Post Market Surveillance Project Manager
(this is Not IT Project Management)
Project Managers provide business and technical leadership for work streams and/or projects as part of major, high-complexity programs (e.g., Baxter Top Projects, Product Authentication and Labeling) within the organization. They help drive their project teams through all phases of the appropriate development life cycles. Project managers facilitate cross functional cooperation to achieve results and collaborate with medical affairs, post market surveillance, vigilance, marketing, legal, regulatory affairs, quality, supply chain, manufacturing, labeling and purchasing to develop and achieve project objectives/results. This person will interact with and influence internal and external stakeholders in identifying project requirements, deliverables and corresponding timelines. Project Managers will make launch date commitments to businesses and manage stakeholder expectations with regard to Baxter deliverables during the project. The Project Manager will develop core team and project management capabilities across the organization.
Essential Duties and Responsibilities
• Accountable for core team performance, project schedule and execution, budget commitments and spend
• Interacts through project updates and reviews with all functions and levels of management ensuring effective ongoing communications across teams and stakeholders
• Ensures identification and communication of project risks, development of risk plan and proactive management of risk response strategies
• Anticipates potential conflict situations for proactive solutions and manages conflict situations to result in win-win outcomes
• Supports the Clinical & Post Market Surveillance Workstream Leadership in managing the successful delivery of the Clinical & Post Market Surveillance deliverables in accordance with timelines
and their respective dependencies
• Understand the Clinical & Post Market Surveillance required deliverables and the cross functional nature of resources required to develop/review/approve these deliverables; ensure project process aligns with relevant Baxter enterprise processes
• Disciplined project management background preferred with the ability to perform the all aspects of PROJECT MANAGEMENT including:
o Establishing SCOPE and managing changes to scope,
o Defining a project SCHEDULE with input from the development team and maintaining the schedule on a weekly basis.
o Managing project RESOURCES including technical and non-technical team members such as developers, Business Analysts, System Architects, Database Administrators and Validation Analysts.
o Strong COMMUNICATION skills including the ability to establishing appropriate COMMUNICATION plan and executing to plan. Other responsibilities include interacting with customers to understand their business and managing the customer relationship with business project sponsor.
o Working closely with the QUALITY management and system owner to execute appropriate validation plans.
• Business acumen
• Role model of Vital Behaviors and Leadership Essentials
• Understanding of Good Manufacturing Practices, Good Laboratory or Clinical Practices and Product Development Process requirements
• Expertise in all aspects of project management
• Ability to apply business process models to project approach for developing/reviewing/approving deliverables
• Demonstrated ability to supervise and develop others
• PMI or IPMA or equivalent certification, nice to have
Education / Experience
• A minimum of an MBA/MS or Bachelor’s with equivalent plus 7 years project management experience and 10 years of product life cycle experience with demonstrated success leading multi-site, global or enterprise-wide programs in the medical products industry
• MS Project, Excel (Pivot Table & V-Lookups, reporting, strongly preferred), Word, Outlook, PowerPoint, & SharePoint
• Previous Medical Device / Pharmaceutical / Biotechnology industry experience be required
Interview Platform: Phone followed by onsite, depending on the availability.
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