At Johnson \& Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
Medical Affairs GroupJob Sub Function:
Medical AffairsJob Category:
Scientific/TechnologyAll Job Posting Locations:
Wien, AustriaJob Description:
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, finance teams
local legal and healthcare compliance
EMEA Centre of Excellence, supply chain, quality, cell therapy commercial operations
Support to hospital sites:
Primary contact: Nurse coordinator, apheresis \& cell lab team, pharmacist
Secondary contacts: CAR-T physician, CAR-T team, IT, hospital manager
Job location
Can be home or office-based in EMEA, preferably in a supported country with established CAR-T commercial operations.
The role can involve up to 10% domestic travel
Requirements
Proficiency with IT systems
English proficiency
Fluency in local language(s)
Knowledge \& skills
E2E thinking and business acumen
Service and process orientation
Communication skills
Ability to navigate complex settings that involve multiple stakeholders
Ownership mindset – ability to act to “make things happen”, operate within agreed frame, and navigate J\&J to influence decision makers
Detail-oriented in managing process
Understanding of data privacy and pharma compliance rules
Awareness of, and adherence to, Johnson \& Johnson Credo values, policies and SOPs
Proven ability to establish and cultivate key relationships
Proven ability to manage complex settings that involve multiple stakeholders and the ability to interact with medical and administrative officials
Experience
Masters or Bachelor’s degree (medical or scientific discipline).
3-5 years of prior experience in customer facing role, ideally in a hospital (e.g., patient care coordination) or working with hospitals (e.g. customer service or local trial management)
Experience working with multiple internal stakeholders
Experience working in a transplant unit is a plus
Cell therapy experience is a plus
Supply chain experience is a plus
Required Skills:
Preferred Skills:
Analytical Reasoning, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaborating, Communication, Critical Thinking, Data Analysis, Data Savvy, Digital Culture, Digital Literacy, Healthcare Trends, Medical Affairs, Medical Communications, Medical Compliance, Product Development Lifecycle, Report Writing, Stakeholder Engagement, Technologically Savvy