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蓝海赛道,负责跟进医疗器械新产品项目的内部研发和对外合作的临床研究
负责领导从概念设计到量产的IVD医疗器械产品的开发, 重点是机械、产品及外观设计、微流体和软件的集成
Making sure local and imported formulation or raw material are under GC regulationsTake responsibility of imported and local raw materials as well as formulation complianceSupport registration when necessary
负责多产品策略的portfolio管理及专业治疗领域的临床研发计划的制定与执行。涵盖特定疾病领域相关研究的策略方案、执行,对研究结果进行准确的分析及解读。并且兼顾团队人员能力的发展与管理。
承接公司总体战略方向,协助职能总监制定公司中长期发展策略规划(包括核心业务中长期发展策略与业务组合中长期发展策略);
作为战略与运营副总裁兼董事长助理,主要负责集团层面战略落地、运营提升、精益管理、业务流程优化等工作
In collaboration with the Medical Director, supports the development of study protocol and amendments, clinical sections of regulatory documents, including investigator brochures, annual safety update reports; contributes to study documents, including AE section of ICF templates, eCRFs and SAE report forms.
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