Medical Writing Supervisor/医学撰写主管

Main Tasks & Responsibilities 主要工作职责 :

1. Responsible for documents in a particular product area, overseesan******** the entire document an******** lifecycle. This includeskickoff meetings to define assignment scope (content, qualityan********) with key stakehol******** document template/shellcreat******** internal review an******** processes (iterative QC checks,version control, team review an******** resolut******** finalizationan********).

负责具体产品领域的医学文件，监督和管理文件准备和整体递交周期。工作内容包括召开启动会议和主要利益相关团队确定职责范围（内容、质量和时间表），创建文件模板/框架，内部审阅和批准流程（交互质控检查、版本控制、团队审阅和解决修改意见、定稿和批准）。

2. Responsible for the on-t******** properly formatte******** highquality delivery of clinical study documents an******** communicationsin accordance with all relevant company SOP********, regulatoryre******** an********

control system********

负责临床试验文件和有关交流的及时完成、格式规范和高质量交付。工作过程符合公司相关 SOP，注册法规要求和质控系统/步骤。

3. Partnering with internal an******** SMEs an******** cross-functionalcollaboration******** to ensure completene******** in documentationan******** the define********, content an********.

与内部和外部 SME 合作，协调跨部门合作/会议以确保文件写作的完整性和准确性，并满足预定的质量、内容和时间。

4. Monitoring quality of assigne******** an******** cons********frequent an******** quality control checks.

对于分配给自身的工作，监督其质量，进行持续、频繁和完整地质控检查。

5. Serving as the primary contact for assigne******** an********accountable for ensuring successful complet******** including anobligation to report any concerns or completion risks to the MedicalWriting Manager.

对自己的工作负责，确保其成功完成。如果对项目完成有任何风险顾虑，需要向直接经理汇报。

6. Assisting Medical Writing Manager with process improvementact******** such as updating team SOPs, gu******** optimizing documenttemplates, improving quality control (QC), developing technicalsolutions to monitor/improve document ******** etc.

协助直线经理进行流程优化，例如更新团队内部 SOP、指南、优化文件模板、改进质控、开发技术解决方式以监控/提高文件质量等

7. Effectively communicating an******** healthy working relationshipswith other Medical Writing team members an******** with whom he/she willwork closely.

有效沟通并与团队内部成员和其他部门 SME 建立良好的工作关系。


Basic Requirements of the Job 基本任职资格:


You shoul******** at least Master’s degree or equivalent in medicalrelated, life sc******** pharmacology, clinical laboratory orbiochemistry.

医学、生命科学、药学、临床实验室、或者生物化学硕士及以上学历。



You shoul********:

1. Knowledge an******** of the clinical research process, including ICHGCP, an******** guideline for in vitro diagnostic test.

了解临床试验流程，包括 ICH GCP 和中国国家食品药品监督管理总局对体外诊断检测的指南。

2. Proficiency in spoken an******** English

熟练掌握英文口语和书面表达

3. >5 years scientific research and/or medical writing experience inpharmaceutical or biotechnology industries with a variety of clinicalan******** ******** including clinical study protocols an********.

制药企业和/或者生物科技工业界从事科学研究或医学写作有至少 5 年相关工作经验，准备过包括临床试验方案和报告等临床注册文件。