Responsibilities:

1.      Demand forecasting and monthly D&OP process for development compounds.

2.      Management of CMO/Vendors for scheduling all packing, labeling, distribution activities to meet study milestones. Includes issue resolution with Quality Assurance.

3.      Importation of clinical trial materials into China. Includes preparation, collection and application of required documents (Import License etc.)

4.      Comparator procurement (from China market/Global market).

5.      Development of China local clinical labels. Includes creation of label text, translation, and label proof.

6.      Budget management/tracking support (sharing actual GMP processing activities versus plan to Clinical Supply Operation Project Management representatives and Supply Planning & Logistics representatives).

7.      Coordinates authorized destruction of investigational products with approved vendors and obtains required documentation. Responsible for updating relevant Trial Master Files(TMF) with CSO-related documents

8.      Participate in continuous improvement initiatives designed to enhance process and technology across Global Clinical Supply Operations

9.      Identify emerging trends, technologies, and best practices and work with Global Clinical Supply Operations management to implement change as appropriate.

 

Qualifications:

1.      Bachelor Degree is required. Master Degree or PhD is highly beneficial. Degree in pharmacy or related field is preferred.

2.      Minimum 5 years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development. Oncology experience is preferred.

3.      Experience of working in global environment in interdisciplinary teams.

4.      Experienced in supervising, coaching, motivating, training and mentoring junior staff members including effective work delegation.

5.      Strong scientific technical knowledge, provide committed value-added effort in support of development and commercial projects.

6.      Excellent personal and intercultural skills paired with ability to work cross functionally in a multinational organization.

7.      Excellent written and oral communication skills in English.


岗位负责人:weijia