Emea Cell Therapy Case Manager

Job Function:
Medical Affairs Group
Job Sub Function:
Medical Affairs
Job Category:
Scientific/Technology
All Job Posting Locations:
Wien, Austria

Overall purpose of the role

• To make the link between commercial operations, medical affairs, Supply Chain and CAR-T sites
• To support certified CAR-T sites on a patient-level, acting as the main point of contact for the cell therapy nurse coordinator and other relevant stakeholders (apheresis team, pharmacist, physician etc)
• To facilitate the patient and the cell journey and provide support to the different stakeholders throughout it
• To provide day to day support and individual case management support to ensure smooth service delivery and facilitate cell logistics
• To support the onboarding of the treatment site and relevant stakeholders on the order management IT platform
• To address special situations by routing to appropriate J&J stakeholders and coordinating with them to reach the desired solution

The Cell Therapy Coordinator (CTC) is an EMEA role dedicated to CAR-T operations at a local or cluster level and contributing to delivering a best-in-class customer experience. EMEA CTCs are closely connected together in a functional network.

Main activities / tasks

• Local and regional CAR-T team membership and collaboration
• Support one or more Operating Company as primary CTC
• Act as a local CAR-T expert on CAR-T operations and logistics
• Direct any special situations to relevant local and regional stakeholders and provide status updates
• Contribute to the regional CTC team by sharing local experiences and best practices
• Support to treatment centres for case management
• Collaborate with the local team to support the onboarding of the treatment site on the case management IT platforms, ensuring the right stakeholders get the right information
• Collaborate with site stakeholders, especially nurse coordinator, apheresis team and pharmacist to coordinate all CAR-T related operations including the delivery and receipt of the final manufactured product
• Support patient enrolment by verifying completeness of information through the case management platform
• Assist the process from ordering, cell processing, cell transportation and delivery
• Collaborate with internal stakeholders to solve issues in ordering or manufacturing according to company policies
• Support rescheduling and cancellations when needed
• Proactively communicate with sites, leveraging the internal IT platform, and address sites’ queries
• Ensure coordination with back up CTC in case of absence
• Enable synchronisation of patient and cell journey
• Proactively check and facilitate order processing by collaborating with J&J stakeholders (Supply Chain, Customer Service, CTAL )
• Coordinate cell pickup and delivery in collaboration with vein-to-vein and based on site preferences
• Oversee the cells status location and timelines and communicate frequently on any changes or delays
• Ensure positive customer experience
• Collect and communicate issues / requests received from customers, coordinate triaging and resolution of issues related to day-to-day site operations, IT platform, patient journey or others
• Along with the CTAL, serve as point of contact for site for any logistics or operational issues and bring in additional resources until issue is resolved
• Ensure operational performance and fulfilment of obligations
• Understand key supply chain processes, such as SC planning, delivery and enablement
• Confirm labelling and documentation requirements
• Coordinate with the CTAL and CAR-T EMEA COE to communicate site demands regarding manufacturing slot availability
• Liaise with local MAF to ensure right information and support is provided for adverse event reporting
• Provide insights to local team and regional teams into CAR-T operations to enable continuous improvement initiatives to cell collection and processing process
• Timely report any issues to the appropriate stakeholders and routes (e.g. system bugs, Product Quality Complaints or Escalations)

Accountabilities

• Be up to date with technical and compliance-related training on CAR-T and myeloma
• Act in full compliance with relevant local and regional regulations and SOPs, in particular:

• Data privacy
• HCBI / promotional rules
• ATMP regulations
• Quality
• Company SOPs
• Pharmacovigilance
• Be ready to support any audit or inspection from local health authorities
• Support patient treatment by providing guidance and coordination with J&J operations, verifying completeness and documentation of information, and addressing any unusual request by routing to local or regional stakeholders as needed
• Strong collaboration with local Cell Therapy Account Lead (CTAL)
• Update internal case management platform with the latest case information and share reports with internal stakeholders when needed

• Collaborate with:

• local medical, commercial, customer service, quality, f