上海凯莱英生物技术有限公司
医学写作经理/高级经理
Skills
2 months ago
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Important information
Contract type:
Permanent
Location:
Nanjing, Jiangsu, China
Work mode:
Onsite
Published on:
4 September 2026
What they need
该职位来源于猎聘 岗位职责： 1.负责医学文件的撰写、审阅、修订与更新，包括但不限于临床试验方案、临床试验报告、研究者手册、知情同意书、M2.5与M2.7 2.协助医学信息、医学策略、商务竞标工作 3.协助AI撰写工具的开发及完善 4.协助医学写作部门相关SOP及工作手册的建立及维护 任职要求 1.生命科学硕士及以上 2.1-5年医学写作工作经验，可独立完成医学文件撰写 3.有FDA申报经验者优先 4.有CRO医学写作项目管理（包括客户对接）经验者优先 5.熟悉ICH、FDA、EMA、CDE相关法规及指导原则 6.良好的英语听说读写能力 7.逻辑清晰、表达精准、注重细节、善于沟通与合作、灵活的多线程工作能力
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