岗位职责：

(1)熟练掌握并严格执行第一三共注册文档相关SOP以及药监当局对注册文档的要求，确保注册文档符合相关要求；

Well understand and strictly implements registration document related  SOPs of Daiichi Sankyo and requirements for registration documents of the health authority to ensure that the registration documents comply with relevant requirements;

(2)对注册文档实施QC工作，对数据和信息的准确性以及上下文的一致性进行检查；

Implements QC work on registration documents, including checking the accuracy of data and the consistency of context;

(3)使用文档管理系统（Veeva-Vault）对注册文档实施Submission Ready作业；

Uses electronic Document Management System (Veeva-Vault) to implement the Submission Ready for registration documents;

(4)对特定注册文档（例如CSR）进行编辑和整合；

Edits and integrates specific registration documents (such as CSR);

(5)不断提高注册文档优化流程的质量和效率；

Continuously improves the quality and efficiency of the document excellence;

(6)与注册团队保持及时有效的沟通，为注册文档准备工作提供支持；

Maintains timely and effective communication with the registration team to provide support for the preparation of registration documents;

(7)完成直线经理安排的其他工作。

Completes other tasks assigned by the line manager.

资历要求：