Clinical Supply Associate (Contractor)

Description

General Mission:

The Clinical Supply associate is a supportive role responsible to providing support to clinical supply chain in executing supply strategies matching needs of clinical programs and trials to ensure on time delivery and optimal supply coverage for API, DP and packaged materials, including supportive documentation, maintaining metrices, communicating with and providing feedback to key stakeholders (Clinical team, CMC team, P&L team, logistic and distribution team). This position will be located in Shanghai.

Specific Missions:

• Act as Clinical supply Chain Co-Ordinator for assigned projects and help orchestrate all clinical supply activities to successfully deliver a clinical program in co-ordination with other Clinical supply function.
• Participate in sub-team meetings, CS&OP meetings and contribute in resolution of critical risks and issues, include communication to key stakeholders. Assist in developing and executing a well-designed integrated demand and supply plan from API to Kit.
• Communicate as a representative of the Clinical Supply Chain with the CMC team and the Clinical team for the product strategy.
• Manage all logistics issue resolution activities, incl. quality-event investigations, related to the assigned compounds for finished kits
• General activities in support of the global clinical distribution network
• Develop close working relationships with other Clinical Supply Chain organization and cross-functional business partners.
• Assist in GCP and GMP health authority inspections.
• Mostly interact with internal stakeholders, occasionally with external.

Qualifications

Profile Needed for This Function:

Knowledge

• Preferably experience with clinical trial operations, project management, pharma/bio research and development are preferred
• General knowledge of GxP principles is required
• Knowledge of global transportation, trade compliance requirements is a plus
• Excellent written and verbal communication skills, able to communicate clearly, making the complex clear and compelling to all levels of the organization in both written & oral forms are required.
• Ability to work in a global, complex and high-pressure environment, acts with speed, flexibility, and accountability to achieve goals is required
• A minimum of two (2) years of professional related business experience is required, preferably in a clinical supply related role

Degree

• A minimum of a bachelor’s degree in a pharmacy/scientific/medical-related major is required

Languages

• Local, English, Japanese is desirable

Specific Know How of Systems

• Advanced Microsoft Excel skills
• Experience with clinical supply demand management tools (e.g. IVRS, SAP, OMP+) is preferred
• I ntermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint) is required