Description/职位描述:

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:

61 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.

61 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.

61 Communicate as a representative of the Clinical Supply Chain with
the CMC team and the Clinical team for the product strategy.

61 Manage all logistics issue resolution activities, incl.
quality-event investigations, related to the assigned compounds for finished
kits

61 General activities in support of the global clinical distribution
network

61 Develop close working relationships with other Clinical Supply
Chain organization and cross-functional business partners.

61 Assist in GCP and GMP health authority inspections.

61 Mostly interact with internal stakeholders, occasionally with
external.

Qualifications/任职要求:

Profile Needed for This Function:

Knowledge

61 Preferably experience with clinical trial operations, project
management, pharma/bio research and development are preferred

61 General knowledge of GxP principles is required

61 Knowledge of global transportation, trade compliance requirements
is a plus

61 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.

61 Ability to work in a global, complex and high-pressure
environment, acts with speed, flexibility, and accountability to achieve goals
is required

61 A minimum of two (2) years of professional related business
experience is required, preferably in a clinical supply related role

Degree

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

Languages

61 Local, English, Japanese is desirable

Specific Know How of Systems

61 Advanced Microsoft Excel skills

61 Experience with clinical supply demand management tools (e.g. IVRS,
SAP, OMP+) is preferred

61 Intermediate to advanced software skills (e.g., Microsoft Excel,
PowerPoint) is required