医学撰写主管/经理-早研（郑州）(J10362)

1. Be capable of independently conducting project research, literature research and information organization;

能够独立开展项目调研、文献查询和信息整理;

2. Lead IB / protocol / CSR/ registration materials (e.g., M2.5 & M2.7) writing and translating and SOP maintenance, ensure full GxP and Related Guidance compliance in materials;

主导撰写和翻译研究者手册/方案/临床试验报告/注册资料（如M2.5&M2.7）/完善SOP，并保证符合GxP和相关指导原则的要求；

3. Answer and handle medical issues during the project execution process, interpret and analyze the data, and organize the results;

对项目执行过程中的医学问题进行解答和处理，对数据进行解读及分析、结果整理;

4. Participate in some medical monitoring work;

参与部分医学监查工作;

5. Conduct study design independently for supporting business development；

独立开展方案设计支持商务发展；

6. Fully responsible to deliver assigned projects under established timeline;

负责在规定时间内交付安排的项目；

7. Conduct training for new employee and relevant staff;

对新员工和相关人员实施培训

8. Maintain a good communication and interaction with sponsor, clinical center and other relevant unit;与申办方，中心和其他相关部门保持良好的沟通和交流；

9. Maintain a good communication and interaction with line-manager.

与直线领导保持良好的沟通和交流。

Master/Ph.D. degree in clinical medicine / clinical pharmacology or in relevant area.

临床医学/临床药理或相关专业，博士或硕士教育背景。

At least 3 years of work experience in clinical pharmacology depending on the degree, direct CRO/Pharma or other business –related experience, experience of clinical pharmacology studies is highly desirable.

根据学历至少3年临床研究经验，CRO/制药企业或其他相关的业务经验。

Good knowledge of clinical medicine/clinical pharmacology/pharmacokinetics

良好的临床医学/临床药理/药代动力学知识。

Good knowledge and experience (e.g., bioequivalence / phaseⅠ/Ⅱ/Ⅲ study) in protocol design and clinical report compilation。

良好的临床方案设计和报告撰写知识和经验(如生物等效性试验、Ⅰ、Ⅱ、Ⅲ期临床试验)。

Understand current GCP/CLP and related Guidance in CFDA/FDA/EMA/ICH.

了解现行GCP/CLP和其他相关指导原则。

Good in both Chinese and English.

良好的中英语水平。