1.Project reviewing and Time management.
2.As the reviewer to deal with internal QC process for submission and contract negotiation.
3.As a regulatory consultant to provide the regulatory resolutions.
4.Work with department head/Senior manager closely to smooth the department issues.
5.Assisting the assigned tasks.
6.Review and discuss with SSU Specialist for RA/IRB/REC comment reply.
7.Discuss with SSU Specialist or PM/Sponsor or other departments to resolve submission related issues.
8.Work with Project Management or Clinical Operation to offer the submission recommendations regarding the Feasibility Study if needed.
9.Review and discuss with SSU specialist for the preparation of the site contract.
10. Discuss with SSU specialist for the contact negotiation issues.
1.在Global pharma/CRO或本土生技公司累計待超過五年
2.TFDA & IRB實務送審經驗三年以上
3.有醫院合約處理(跟醫院臨床試驗中心打交道)經驗一年以上更好
4.At least a bachelor’s degree in medical, nursing, or life science-related background.
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