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在内部各专业部门和外部合作方的参与下,独立地开展新药(包括创新药、上市后药品、研究者发起研究等)临床试验项目管理工作,进行全面的质量控制和进度管理,确保项目严格按照GCP、SOP、试验方案和注册地法律及法规进行。
Be responsible for Project Management team ( R&D, CMC, Clinical etc ) and Portfolio product life cycle planning and management, connect with R&D and Marketing, proactively consider the future market pattern of products, and design the product life cycle in advance to maximise product value.
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.
Actively manage one or more early or late stage global drug development project teams, executing the program strategy for the specific project, according to the TPP.
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Responsible for managing R&D practices, establishing technical standards and systems, and overseeing project management within the engineering department.Play a pivotal role in driving innovation, developing new technologies, and ensuring the successful execution of engineering projects from concept to implementation.
Represent the brand as a whole in CN
危机公关舆情管理
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