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Sr. IT Business Analyst - Clinical, Safety, Medical & Regulatory Affairs

Req # JR - 026246 Location Deerfield, Illinois, United States Job Category Information Technology Date posted 09/01/2020

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We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.

Learn more about how Baxter is At the Intersection of Saving and Sustaining Lives.


This position will be part of the R&D IT team, supporting the Regulatory Affairs, Global Patient Safety, Medical Affairs and Clinical Affairs portfolio of projects.  This is a senior-level IT business analyst position.  The ideal candidate will have the following experience:

  • Implemented a new SaaS software vendor solution from beginning to end, including system integrations
  • Managed the creation and approval of the deliverables in a validation package
  • Designed the data flow through a new software solution, including upstream and downstream interfaces
  • Redesigned business processes to match the new software solution’s functionality and data flow
  • Led requirements gathering across many global functional teams for a new software solution
  • Collaborated with a software vendor (i.e., understanding the capabilities of the software vendor solution and identifying gaps/mitigations, resolving test defects, etc.)
  • Regulatory Affairs, Regulatory Information Management, Clinical Affairs, or Patient Safety

Key Responsibilities:

Business Enabling and Envisioning

  • Engage and communicate effectively with business leaders and business subject matter experts to define and align on constructive and tangible strategies
  • Collaborate with business partners to influence core technology selection and standards across a diverse range of business-critical R&D solutions
  • Best in class vendor selection and management, including niche vendor strategies as needed
  • Plan and execute global requirements gathering through workshops/product demonstrations at both global and regional level whilst maintaining traceability and compliance at the core
  • Deliver presentations; facilitate and address issues at all levels of management

Business Analysis

  • Lead and set direction for business functional requirements, technical requirements and solution delivery on enterprise/large projects within Baxter’s R&D IT function
  • Gather, understand and document business objectives, requirements, functional specifications through workshops/interviews/meetings
  • Manage the creation and approval of the deliverables in a validation package
  • Identify, evaluate, develop and /or redesign systems and procedures that meet user requirements
  • Understand interdependencies of systems for multiple businesses or functions
  • Design data flow through software solutions, including upstream and downstream interfaces
  • Use technical tools (queries, process maps, etc.) for problem resolution     
  • Conduct data analysis; design business rules for data accuracy and consistency; design data mapping and data migration.  Identify and resolve data quality issues
  • Establish validation test strategy; develop and execute test cases; lead validation testing with IT and business partners; manage defects with software vendors and IT
  • Assist in development of training materials and/or conduct training
  • Provide support on R&D business applications
  • Understand and follow appropriate SDLC, quality validation processes and application processes
  • Communicate status, solutions and concerns
  • Disseminate information in a timely manner within the team and across functions
  • Make decisions that have a cross-functional or business impact and analyze financial impact
  • Provide input to project manager on project charters, project plans, project estimates/budgets and status reports

Key Qualifications:

  • Bachelor's degree in Information Technology
  • 7+ years of business analysis experience and implementing IT solutions
  • Prefer 2+ years of regulatory affairs, regulatory information management, patient safety, or Clinical systems’ experience
  • Prefer experience with Veeva PromoMats or RIM or other vault products.
  • Demonstrate strong business acumen, solution delivery expertise and a strong understanding of systems for both on-premise and SaaS offerings
  • Proven success (3+ years) managing large project requirements highly desired
  • Ability to accomplish results through others, utilizing effective influencing and leadership skills
  • Must be able to solve complex business problems and present recommendations to senior management effectively
  • Must be able to define, shape, and drive projects to completion while effectively collaborating with others
  • Experience working on all SDLC business processes: requirements, design, development, testing, training and deployment
  • Experience working with third-party external teams in the support and implementation of IT solutions
  • Data analysis and data migration experience
  • Require limited direction; detail and quality oriented; possess extensive knowledge of policies, standards and procedures; have excellent presentation, communication, teamwork and interpersonal skills

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.

EEO is the Law 
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Pay Transparency Policy

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to and let us know the nature of your request along with your contact information.

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