The Role
- 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
- 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
The Company
What We Do
Inteldot offers custom turn-key systems, systems integration, MES eBR configuration and integration solutions, business intelligence and analytics and technical staffing.
We have been providing the Pharmaceutical, Manufacturing and Medical Device industries with services for a variety of applications since 2004
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