Sr Business Analyst (Supply Chain)

Sr. Business Analyst/Pharmaceutical Clinical Supply Chain with business process and technology expertise:

Individual will support a new initiative to manage clinical supply chain and patient journey:

Responsibilities:

• Support refinement of business requirements specification to meet company needs
• Articulate, review and elaborate use cases and corresponding business requirements in partnership with supply chain, manufacturing, clinical and quality.
• Manage configuration of system according to use cases and business requirements.
• Partner with vendor and internal stakeholders to update and refine project documentation
• Coordinate review and approval of project and validation deliverables across stakeholders
• Test drive use cases and system configurations to ensure it meet business needs
• Highlight configuration issues with vendor and ensure to keep track of reported issues and fixes
• Work with offshore testers refine test scripts
• Provide support for development of business process documentation, SOPs, and WIs as needed.
• Track overall milestones, issues, and risks related to delivery of project
• Support development of project plans in accordance with business practices and integrating internal and vendor activities
• Support development of training plan for rollout of business system capability across global clinical sites
• Support development of support model for technology, process, and data
• Support development of business process diagrams based on system functionality

Experience:

• Must have Understanding of Pharmaceutical Supply Chain
• Must have understanding of systems and technologies to support pharmaceutical supply chain
• Must have understanding of clinical trials, site start-up, and clinical supply chain processes
• Prefer having experience with deployment global capabilities in support of supply chain, clinical, and commercialization of cell and gene therapy
• Have a good understanding of project management including agile methodologies
• Have a good understanding of business analysis methodologies
• Background with deploying capabilities across FDA regulated industry and background must include validation
• Background with cell therapy supply chain is a plus
• Experience with Trakcel, CellChain or Vineti Supply Chain Software is a must