• Be part of the technical team and discuss packaging design with Clinical Supplies Integrator & manage timelines with Supply Chain Managers.
• Ensure financial and payment responsibilities are taken care of: Obtain quotes and ensure approval of the quotes. Review invoices and provide feedback to ensure PO's are covered
• Coordinate packaging projects with packaging contractors
• Negotiate timelines and follow up on the progress of the project to assure timely release and distribution of the clinical material to the clinical site
• Deliver all necessary documentation and information
• Review packaging instructions and label copy, ensure availability of randomization information, obtain and/or coordinate pre- and post-packaging approvals.
• Escalate potential missed timelines and look for possible solutions to minimize impact.
• Assist periodically in monitoring contractor performanceThis information/knowledge must be applied in all projects where applicable, hence the following responsibilities:
• Setup of the required cross-linked information platforms (QA, Manufacturing, Prevention, PDMS/JSC…)
• Review Master Service Agreement and define Scope of Work at CMO
• Follow-up on orders and invoicing according to project plan
• Periodic review and score card monitoring of CMO’s
• The ESI Logistic Coordinator will help to manage the operational budget as a devoted housekeeper. He/she has strong responsibility with respect to the dedicated operational and project budget.
• The ESI logistic coordinator will co-ordinate with Internal and External stakeholders of different function to implement Clinical batch execution as per schedule.

Qualifications

• University/Bachelor Degree preferably in pharmaceutical, Biopharmaceutical or Equivalent
• Experience, Generally requires (2-5) years related experience
• Experienced in utilizing appropriate software to effectively manage a supply chain (e.g. inventory management system)
• To work with different software systems depending on vend
• Basic knowledge on GMP or good documentation practices

Operational and data analysis skills

• Good documentation practices
• GXP, Regulatory requirements including CFDA guidelines, Technical Safety Standards
• Excellent knowledge of English (spoken and written)
• Willing to travel (up to 40%)

Primary Location
China-Shanghai-Shanghai-
Other Locations
China-Shanghai-Shanghai
Organization
J&J (China) Investments Ltd (7046)
Job Function
Clinical Supplies
Requisition ID
00001F05