Inteldot has over 14 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in USA.
Position Overview: Individual will support patient centric supply chain system for cell therapy.
Responsibilities:
New Project and Functionality
- Develop vision and plans for evolving system functionality to support continuous improvement and to commercialize cell therapy.
- 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.
- 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.
- Track overall milestones, issues, and risks related to delivery of project
System Configuration and Release Management
- Manage configuration of system according to use cases and business requirements.
- Highlight configuration issues with vendor and ensure to keep track of reported issues and fixes
- Manage bundling of new releases to address new functionality and address issues.
- Work with offshore testers refine test scripts
- Provide support for development of business process documentation, SOPs, and WIs as needed.
- Support development of training plan for rollout of business system capability across global clinical sites
Provide System Administration
- Act as System Administration for on-going support and maintenance in collaboration with vendor.
- Manage incidents and resolve user issues across internal and external communities.
- Keep track of system performance and SLAs.
Experience:
- 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 Salesforce platform for configuration/development, reporting, and administration.