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Clinical Research Scientist

Clinical Research Scientist

募集業種
Clinical Research Scientist
職務内容
Reporting to the Head of Clinical Research Japan, the Clinical Research Scientist (CRS) plays an integral role in the scientific planning, execution and reporting of Japanese clinical studies for development compounds. Although generally assigned to a specific therapeutic area, the CRS may support local clinical research activities across development programs. The overall responsibilities of the CRS include the following: ・Acts as the local scientific expert for assigned clinical research activities, addressing questions from internal functions and external Japanese physicians and research scientists. ・Provides scientific support to functions including but not limited to GSI Clinical Research, Clinical Operations, Biostatistics, Data Management, Medical Writing and Medical Affairs. Provides guidance to ensure scientific and clinical issues are addressed in a consistent manner ・Responsible for identifying, establishing and maintaining science-based relationships with Japanese therapeutic area experts to support development programs. ・Responsible for the design of Japanese clinical research studies including authoring of study concepts and protocol synopses. Works with the Clinical Operations team for the development, finalization and amendment (as applicable) of study protocols ・Prepares and presents (if applicable) scientific information concerning development programs internally and at external meetings as required. Responsible for drafting regulatory Briefing Documents and slide presentations for use at ・PMDA and MHLW meetings. Attends and presents position at informal and official Consultation meetings with PMDA and MHLW ・Working with Regulatory Affairs and the respective GSI Project Team, prepares written responses to PMDA, MHLW and IRB queries.
経験/資格
・MS degree or above. ・Minimum of 5 years of experience within clinical research in the pharmaceutical industry. Experience in cardiovascular area is preferable (not mandatory). ・Experience in preparation for and attendance at PMDA/MHLW consultation meetings. ・Direct experience in the preparation and filing of CTNs, J-NDAs and other clinical research documentation. ・Current, working knowledge of ICH and local guidelines and PMDA/MHLW notifications. ・Good communication and discussion skills to build and maintain working relationships with Japanese physician and research scientists. ・Strong organizational skills and ability to manage multiple projects simultaneously. ・Fluency in oral and written English.
勤務地
東京

企業データ

会社名
非公開 まずはエントリー下さい。
設立
2012年
資本金
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従業員数
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