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临床注册经理(J16701)

CTTQ Pharma · 上海市, 北京市

Imported listingfull-time4 days ago

About The Role

  1. 负责新药临床试验申请（IND）的资料准备、递交、答复；
  2. 负责临床试验期间各类变更（方案修订、适应症扩展、新增中心等）的注册管理；
  3. 负责临床试验登记与更新（NMPA、<ClinicalTrials.gov> 等）；
  4. 参与药监部门沟通交流会（Pre-IND、EOP2、Pre-NDA）的资料准备；
  5. 负责 IRB/伦理委员会备案、遗传办备案（如涉及）；
  6. 撰写 CTD 模块 5 临床部分（CSR、ISS/ISE、SAP 审阅）；
  7. 跟踪解读国内外临床试验相关法规动态。
  8. 医学/药学硕士及以上，临床医学专业最佳；
  9. 5年以上临床注册 / 临床项目管理经验；
  10. 熟悉 ICH-GCP、中国 GCP、《药品注册管理办法》；
  11. 英文写作流利，能读懂 CSR/SAP、独立撰写英文 IND 答复函；
  12. 优秀的跨部门沟通和解决问题的能力。

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