职位描述:
1. Responsible for compoun******** analys******** engage incompoun******** strategy an********.
负责产品临床可行性分析,参与设定产品研发策略
2. Responsible for the study ******** writing clinical trial protocol,provide medical expertise in developing clinical trial reports, summary******** an********'s brochure, an******** relevant documents.
负责临床试验方案的设计与撰写,为临床试验报告、总结文件及与研究者手册等医学相关文件提供医学支持。
3. Provide medical support to implementation of clinical tr********including medical mon******** medical training an********-relate********review an********.
对临床试验过程进行医学支持,包括医学监查,医学培训,医学相关文件审阅与撰写。
4. Provide medical insight an******** when communicate with KOLs orhealth authority experts for compoun********/or clinical trialsdevelopment.
与临床专家或者国家监管机构沟通产品或临床试验相关内容。
5. Assessing product safety events an******** that affect clinicaltrials.
评估产品安全性事件和影响到临床试验相关的事件。
6. Responsible for internal an******** interpretation of productefficacy an******** information.
负责内外部解读产品疗效和安全性信息。
7. Provide support to literature search and/or medical advice.
提供文献或者医学咨询支持。
8. Provide support to competitors' landscape update.
定期更新目标适应症的治疗药物和方法数据信息。
任职资格
1. Master degree or above, me******** oncology, pharmacology, orbiological background, experience in oncology is preferred。
硕士以上医学、或肿瘤学、或药理,或生物学背景,以肿瘤经验者优先
2. Familiar with clinical trial regulations an********.
熟悉临床试验法规与指导原则。
3. Soun******** skills with external medical experts and/or experts inregulatory agencies.
有能力和外部医学专家以及监管机构沟通。
4. Goo******** an******** communication for daily work – writtenan********, experience in medical writing is preferred.
中英文口头和书写流利,有医学撰写经验者优先。
5. Proficiency in office software.
熟悉办公室软件。