岗位职责：

1. Drafting documents for submission to CDE/FDA/EMA, including but not limited to: Clinical Evaluation Report, protocols, CSR, and other documents required by the project team

2. Coordinating project team review and document deliverables according to SOPs/WI and timeline, including distributing drafts, incorporating revisions, translation and proofreading, and completing the sign-off procedures for the required documents

3. Participate in establishing and updating SOPs for writing related medical documents; Responsible for establishing, developing, and maintaining writing templates for clinical research protocols, clinical research reports, and other related medical documents; Participate in establishing, updating, and maintaining various writing tool forms within the department

4. Collaborate with relevant functional departments, actively participate in clinical research meetings, understand and accurately articulate clinical research results, and complete medical documents on time in accordance with relevant national regulations, ICH-GCP, company SOP, and strategic development requirements

5. According to relevant SOP requirements, conduct quality control on various medical documents within the same department

6. Write medical professional articles based on clinical trial results and literature.

7. Provide medical training for clinical trial related departments and write medical and other related articles for the company

任职资格：

1. Master’s degree or above in clinical medicine, biomedical science or other similar science majors

1. 3+ years’ experience generating in Life Sciences industry for the role of medical writer，with priority given to those with medical work experience

2. Excellent communication and collaboration in a cross functional team setting

3. Proficiency in both written & spoken English

其他信息
语言要求：英语、普通话
行业要求：全部行业