Temperature Management Coordinator

Job description

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Temperature Management Coordinator, located in Beerse, Belgium.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

Janssen Pharmaceuticals , Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer's disease, epilepsy, migraine prevention and treatment), pain management, and women's health. Our ultimate goal is to help people live healthy lives.

We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market - from patients to practitioners, from clinics to hospitals.

·  The T emperature Management Coordinator is responsible for day to day execution of the Temperature Management & Control for Clinical Supplies during the execution phase of clinical trials consistent with GMP guidelines.
·  This individual will follow standard operating procedures to evaluate all temperature excursions associated to clinical supplies during trial execution ensuring compliance with all SOP, GMP, Quality, and Regulatory guidelines.
·  They will adjust supply dispositions via inventory systems including IVR & IWR based on the outcome of the temperate out of range evaluation.
·  This individual will collaborate with GCDO, DPD, and Quality for TOR resolution.
·  They are responsible for execution of Temperature Monitoring Coordinator role during trial feasibility and throughout trial execution.
·  They conduct the review and approval of all Investigational Site Temperature Management Equipment Questionnaire Approvals (TMEQ) for Cold Chain IMP.
·  They serve as subject matter consultants on temperature management requirements including storage and monitoring capabilities.
·  They customize temperature out-of-range forms based on product attributes.
·  Obtain quotes and complete PO setup to centrally source temperature monitoring devices. Contribute to business process improvement initiatives.
·  Responsible for the Temperature Management & Control of all clinical supplies from feasibility throughout trial execution within the Janssen Pharma R&D portfolio.

Desired profile

·  A minimum of a High School Diploma is required. A Bachelors Degree is preferred.
·  Two years experience in a multi-disciplinary environment or Pharma R&D area is highly preferred.
·  Experience with quality system tools is preferred (e.g. Trackwise).
·  Experience with Interactive Response Technologies for Clinical Trials (e.g. inventory management functionality) is preferred.
·  Experience with the following functions is preferred, clinical operations, logistics, quality assurance, clinical supply chain planning and drug product development.
·  Demonstrated knowledge in Clinical Supply Distribution and Clinical Study Execution/GCP is preferred.
·  Intermediate to advanced software skills (e.g., Microsoft Excel, SharePoint, PowerPoint) is required. Experience in a highly matrixed environment is preferred.
·  Excellent written and verbal communication skills are required.

Position is based in Beerse, Belgium

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