Global Clinical Supply Group
Plans, establishes, manages and monitors activities related to clinical supplies, to support the drug development process (Phase I-IV), in cooperation with internal and external customers and partners in compliance with local regulations as well as internal procedures and GxP requirements. Leads clinical supply activities for assigned projects (in general with high complexity). Supports LTT/CTT-J activities regarding to the supply chain for investigational products (IMPs). Manages and leads cross-functional aspects regarding clinical supplies among the relevant functions.
- Contribute to project progress in Japan
- Measure Japan specific matters
- Review NDA documents
- Achieve timely sample supply for Japan stand alone trials by consolidating sample forecasts, defining clinical samples packaging designs, and supporting trial protocols as a member of LTT
- Elaborate tailor made sample supply strategy
- Check document contents regarding technical matters
- Support adequate sample supply to Japanese region of multinational trials by bridging the responsible partners, TRD-ST-J, LTT/CTT-J, and Global GCS
- Manage custom clearance
- Direct import agents
- Mitigate the necessary activities, forecasting, importing strategies, packaging designs, etc., for clinical sample supply to Japan as a member of Global GCS
- Bridge needs and concerns between local and global
- Speak up Japan specific requirements
- Manage and control the contractors of both packaging operations and packaging materials for clinical sample supplies
- Negotiate and execute local packaging campaign
- Review packaging records and create necessary documents for technical release
- Observe the compliance and the relevant regulations, - Keep financial transparency from estimate, order to payment
- Check stock account regularly
- Get along with latest regulations
- Establish, improve and maintain efficient sample supply process to fulfill the regulational requirements
- Request external audit of contractors/suppliers to global QA
- Maintain local SOPs up to date
- Provide GMP training for relevant partners
- Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures.
- 100% timely delivery of all training requirements including compliance.
- Education: Advanced technical or scientific university degree or equivalent
- Experience/Professional requirement: Preferably 3 years' experience in the pharmaceutical industry
- Basic knowledge of IMPs supply in Japanese pharmaceutical industry and regulatory environment
- Preferably working experience in a global environment
- English Skill: Japanese and English (mandatory)
Full 2 holiday week system (Sat/Sun) national holidays
New year's holiday
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