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.