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At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride. 

Summary:

Collect and analyze product master data and country specific requirements to support Serialization and UDI implementations as well as ongoing data maintenance.

Collaborate with various internal functions, CMO customers and suppliers to; collect and analyze product and regulatory master data, resolve master data issues as well as regulatory alerts for products on the market.

Support the implementation and maintenance of business processes for product Serialization and/or UDI to meet country specific requirements and ensure supply continuity.

Support project execution activities, potentially lead some small project initiatives, and drive continuous improvement activities.

Essential Duties and Responsibilities.  This section contains a list of five to eight primary responsibilities of the work.  The incumbent will perform other duties as assigned.

Collect, analyze, and resolve complaints and regulatory alerts from various business management tools/systems. Collaborate with internal and external stakeholders and partners to investigate and resolve issues in a timely manner to ensure no product supply interruptions. Identify common root causes, and drive process continuous improvement to resolve and prevent re-occurrence.

Lead the collection and analysis of Master product data to meet specific country regulatory requirements.  Utilize various business systems to collect data.  Collaborate with various functions.

Support the development and understanding of key country specific serialization and/or UDI requirements.  Collaborate with various stakeholders to achieve.

Interact with marketing, legal, regulatory affairs, quality, supply chain, manufacturing, external CMO customers and suppliers, and labeling operations to assess scope, complexity, estimates, and timelines. 

Support the Project Managers through the execution of projects tasks to support the overall project execution.  May be asked to lead some small project related activities with internal functions and CMO customers and suppliers. Interacts through project updates and reviews ensuring effective ongoing communications across teams and stakeholders.

Ensure identification and communication of project risks and help identify business solutions and/or capabilities required to address specific business challenges.

 Education and/or Experience.  Include the education and/or experience that is necessary to perform the job satisfactorily.

  N/A:  Intern or Co-op

Experience in business management tools (ie: JDE) to collect and analyze data

Previous serialization or UDI experience coupled with manufacturing / supply chain operations experience is preferred.

Excellent communication, collaboration, and influencing skills

Strong organizational and problem-solving skills

Project management experience preferred

Strong experience working with MS Excel, Word, Outlook, PowerPoint, and SharePoint

Strong business/financial acumen

Dedicated to outstanding customer service

Ability to work under minimal / limited supervision, acting as a self-starter

Medical Device / Pharma Regulatory experience is beneficial

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter 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.

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