医学经理/高级经理(J17777)

职位描述

工作职责

1、制定新药临床研发的策略，为新药的临床研究提供支持及指导：如适应症的选择、临床研究设计、临床研究所需文件（试验方案、研究者手册，等）、总结报告的撰写和审核；Designs the strategies and provides support and guidance for the clinical research of new drugs, which includes choosing indications, designing clinical research, preparing documents (protocol, IB, etc.), writing and reviewing final report;

2、在新药的临床研究过程中提供医学支持及指导，医学监查，药物安全性警戒和管理； Provides medical support, guidance, medical monitoring, drug safety alert and management in the new drugs clinical research process;

3、KOL管理，与临床研究者以及CDE的咨询沟通，筛选leading PI和临床研究中心； KOL management, communicating with investigators and CDE, screening leading PI and site;

4、与项目经理共同制定项目预算和临床试验时间表，促进新药临床试验的进度符合计划安排； Works with the PM to develop project budget and clinical trial timetable which promotes the progress of new drugs clinical trials in accordance with established plans;

5、准备和撰写注册申报所需的临床相关资料； Prepare and write the clinical research materials required for registration;

6、跟踪产品相关领域的医学进展，为公司其他相关部门（注册部、市场部、CMC，等）提供医学支持； Tracks the updates in the medical field of related product and provide medical support to other relevant departments (registration, marketing, CMC, etc.);

7、部门内部的专业知识沟通及培训。 Communicates professional knowledge within the department and training.

任职要求

教育要求：研究生学历，硕士以上学位，医学专业；英语6级以上。 Education requirements: Graduate degree, master's degree or above, medical professional; English level 6 or above.

工作经验要求：；有8年以上相关工作经验，有临床医生工作经验优先。 Work experience requirements: At least five years relevant work experience, clinician is preferred

岗位技能要求：良好的专业英文读能力，熟悉使用计算机。 Skills requirements: Ability to read professional English, familiar with the use of computer.

品性要求：

1）工作积极进取，责任心强； Proactive and strong sense of responsibility;

2）很强的自我约束力，独立工作并能承受一定的工作压力； Self-disciplined, able to work independently and to work under pressure

3）高度的工作热情，良好的团队合作精神； High level of enthusiasm and good team work spirit;

4）良好的沟通能力，有耐心； Good communication skills and patience;

5）为人正直严谨。 Integrity and preciseness