Job Description

1. To keep up and improve the local supply processes in Japan including roles and

responsibilities of involved local and global functions as well as the SOP system which

should be in line with global SOPs and working instructions.

1. To ensure the best set-up, execution and closure of the supply and distribution of

Investigational Medicinal Products (IMP’s) and other clinical trial material in the frame of the

international or local clinical trials, to optimize the performance either on a cost or on a

supply basis (as may be appropriate), in close contact with global Clinical Trial Supply

functions and personnel or venders by taking into account international regulatory and study

specific requirements.

1. To manage the packaging, storage and the distribution(including managing external

vendors) of IMP’s with the main objective of avoiding any interruption of supplies to the

patients/subjects (no stock-outs), and of achieving a smooth supply operation (High

Customer Service Level) taking into account applicable international Good Manufacturing

Practice (GMP) rules.

1. To bring logistic and GMP expertise related to clinical trial material (CTM) to the clinical

trials teams, and take responsibility for the supplies and distribution.

1. To optimize CTM supply related processes by discussing and deciding on roles and

responsibilities with the main interfaces complying with the established quality assurance

system.