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The intern will learn current skills for file management,submissions of clinical trial registration and China PFDA clinical trial filing.
He/She will gain experience in project start, execution and completion in the
pharmaceutical field that will be broadly applicable in other areas of
regulated document management.
Key Responsibilities:• Maintain RA activity tracking system
• Track submissions and authority correspondence
• Support team on knowledge management• Provide support to the clinical trial registration globally
• Participate in document preparation, formatting andpublishing
• Collect documents for China PFDA clinical trial filing
• Archive electronic and paper submission documents
• Document review in eTMF system
• Other tasks assigned
Education, Experience and Skills:• Current Bachelor/Master Degree student with Pharmaceutical or Medical
background.
The R&D (Research and Development) team of Dizal Pharma was AstraZeneca Asia and Emerging Market Research Center. As one of AstraZeneca’s first four R&D centers across the world, it dedicated to analyze the potential scientific mechanism of those most common diseases in Asia and fulfill the particular medical needs of Asian patients. It was one of the few R&D centers established by transnational pharmacy enterprises in China which had the ability to actually research, develop and produce micro-molecular new drugs, the ability to develop produce new drugs independently and completely, and the first-class medical platform in the world.
迪哲医药,于2017年10月独立运营,是一家研发驱动型生物医药企业,致力于全球创新药物(First-in-class/ Best-in-class)探索、研发以及商业化。
迪哲医药的前身为阿斯利康亚洲及新兴市场创新研发中心,设立于中国上海,是阿斯利康全球四个研发中心之一(另三个中心分别位于英国剑桥、瑞典哥德堡、美国盖瑟斯堡);是国际一流、高产出的创新药研发机构,拥有全球领先的转化医学和新药分子设计与筛选技术平台;在恶性肿瘤、自身免疫性疾病、肾病等重大疾病的新药研究方面积累了丰富经验。