Job Description

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.

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 Biopharma`s 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 by taking into account international regulatory and study specific requirements.

To manage the packaging, storage (in case of outsourcing to an external vendor) and the distribution 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 (100% Customer Service Level) taking into account applicable international Good Manufacturing Practice (GMP) rules.

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

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.

Wrok Experience

• Good experience in logistics and/or clinical trial activities
• Other professional experience in the pharmaceutical industry, e.g. Manufacturing, Packaging, Quality Assurance
• Knowledge of international GMP, GDP and GCP rules, especially related to Clinical Trial Material
• Experience in internatinal team work

Skills and others

Must be familiar with IT tools. Mandatory are Word, Excel and PowerPoint

Other Office applications as well as knowledge forecasting tools are an advantage

Ability to work in a structured, reliable and customer directing manner, and to communicate effectively focusing on the key messages

Being assertive and able to work under pressure

Capacity for teamwork and social competence