Project Leader, Labelling

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us is driven to help improve patients' lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Summary:

The Labeling Project Leader is responsible for leading multiple projects within a product labeling program from initiation through project closure with limited direction. This person will ensure that labeling changes are produced and implemented at the associated manufacturing plant. The Project Leader facilitates meetings and communicates with stakeholders to ensure the project adheres to the schedule and scope, and delivers to commitments. 

Essential Scope of Project Leader:

• Responsible for owning, managing and monitoring multiple simple to moderate labeling projects from initiation through completion
• Develops and writes a project scope summary description and rationale based on the labeling request's scope and requirements
• Determine execution strategy in change management system
• Develop change plans activities and monitor activity closure
• Create and manage schedules to track projects to service level agreements
• Interact with global manufacturing plants to implement labeling on product
• Collaborate with global stakeholders to drive projects to completion
• Facilitate meetings to resolve project conflicts
• Monitor and control projects throughout the project lifecycle to mitigate and eliminate risks, resolve issues, schedule delays and resource constraints
• The incumbent will perform other duties as assigned

Qualifications:

• Experience in a global environment in pharmaceutical labeling or regulated industries preferred
• Customer minded with good interpersonal and communication skills and the ability to interact effectively with all levels of local and international organization
• Proficient use of Microsoft Office (Word, PowerPoint, Excel, OneNote, SharePoint)
• Experience understanding project schedules, Microsoft Project a plus
• Understanding of labeling, translation, change control processes and data management systems helpful
• Experience with global cross-functional team meetings
• Knowledge of change management systems preferred

Education and Experience:

• Bachelor's degree or equivalent experience
• 1-2 years of experience in project management or change management
• Working experience in a regulated industry

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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