General mission
This individual contributor is responsible for providing E2E (including API, DP and finished kits) logistics support for specific clinical compounds.
Specific missions
• Logistics activities during clinical trial start-up (E2E):
• Advise on country importation requirements and coordinate country importation readiness for API, DP and finished kits shipments
• Coordinate E2E trade compliance activities to ensure correct and smooth customs processes (IPPF process, HTS codes, product values, etc)
• Develop kits distribution and depot strategy with input from trial supply manager, coordinate depot readiness
• Provide shipping instructions to distribution centers for API, DP and kits shipments
• Advise on adequate shipping solutions
• With guidance, estimate distribution budget, request & challenge depot quotes and coordinate PO process
• Logistics transactional activities (finished kits):
• Perform shipment track & trace activities
• Review, challenge if needed & approve depot invoices
• With guidance, manage and maintain the distribution budget incl. proactively managing any gaps between budget & actuals
• Logistics issue management (E2E):
• Manage all logistics issue resolution activities, incl. quality-event investigations, related to the assigned compounds for finished kits
• With guidance, support/coordinate issue resolution activities for API/DP
• General activities in support of the global clinical distribution network
• Own specific trial independent processes, such as distribution forecasts, maintaining the country importation requirements database, etc
• Manage multiple priorities and work independently while demonstrating initiative and strong analytical savvy
• Thrive in a dynamic environment, while identifying, recommending, and implementing process improvements, for example, by conducting data analyses, and handling multiple projects at a time
• Support other cross-functional improvement projects
• Develop close working relationships with other Logistics team members (Temperature Management & Controls, Strategy, API, Drug Product, and Pack & Label),), with the broader Clinical Supply Chain organization (i.e. Clinical Supply Integrator, Trial & Supply Management, Manufacturing groups) and cross-functional business partners (i.e. Quality, Customer & Logistics Services, procurement, vendors).
Focus and scope
• Responsible for E2E (API, DP and finished kits) logistics set-up, issue management and specific transactional activities for clinical compounds within J&J Pharma R&D (large and small molecules and for all phases of clinical trials).
