[Position] Logistics for Clinical Trials
[Salary] 6~8 million JPY
Note: Applicants must have permission to work in Japan and Fluent ~ Native level Japanese
Global Pharmaceutical Company
The role of the import-export specialist within the Clinical Supply Logistics will include multiple levels of responsibilities providing colleagues with various experience levels to make valuable contributions as well as opportunities for growth. For more experienced import-export colleagues, the expectation is to provide guidance and direction in all aspects of import-export. This role will ensure compliant and effective import-export activities by interacting with internal Compliance teams and Commercial Manufacturing Import-Export teams, support strategic import export initiatives, and participate in the establishment of clear procedures. While all colleagues in this role will be expected to provide training and tactical support to project teams, distribution network, business lines and departmental management, the amount of tactical support a colleague is expected to provide will vary with experience.
Import / Export
- Responsible for the preparation and progression of required documentation for global movements of materials from/to/within research sites and distribution centers (including contract vendors) for clinical and toxicological study; for materials including raw materials, intermediates, API, excipients, drug products, packaging and packaged labelled supplies
- Obtain compliant valuations, HTS codes, FDA product codes and country of origins and ensures these are applied to documentation for international movements
- Provide Import/ Export guidance and direction to Research Lines
- Review and make decisions on Import Strategy documentation
- Interface directly with Global Operations/ Import Operations to provide pre-shipment details to facilitate clearance
- Where necessary, interface directly with the Customs Broker and/or government agencies to resolve issues with entries or provide additional information as required.
- Maintain and enhance appropriate networking relationships with pharmaceutical companies, trade organizations and government personnel
- Continue individual and organizational development to ensure currency and compliance with global import/export requirements
- Provide back up to other Import/ Export Specialists
- BA/BS degree or equivalent - preferably in the pharmaceutical field, logistics or supply chain
- English: Mandatory TOEIC over 800
- Effective in both verbal and written communication.
- Ability to multi-task, manage personal time and manage multiple priorities.
- Proven ability to negotiate and problem-solve.
- Demonstrated ability to apply process improvements and procedures.
- Ability to troubleshoot issues in a timely manner, work with several key partners and systems in a changing environment, deal well with changes to distribution plans and clinical supply hurdles while ensuring high quality output. Able to build strong relationships with key enabling work streams (SCM, CSP, IM, QA/QO/QP) and vendor distribution personnel.
- Understanding of clinical trial logistics, materials management, international distribution and GxP documentation and compliance.
- Experience working with vendors, vendor management and matrixing into vendor systems.
- Import/ export and international distribution experience (preferably in the pharmaceutical industry)
- Considerable knowledge of interdependencies of supply chain principles, practices and concepts and an understanding of the practices, concepts and operations in other relevant disciplines.
- Experience and working knowledge of Clinical Supply Systems.
- Familiar with Supply Chain databases and systems.
- Familiar with IVRS/ IWRS systems
- Experience in management of a third party contractor.
- Understanding of project management concepts.
- Competent in using information systems including MS Office products.
Full 2 holiday week system (Sat/Sun) national holidays, New year's holiday, Annual Leave and more
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.
Seniority Level: Associate
Job Function: Supply Chain