【900～1400万円】【R D】Clinical Scientist R D Hematology Early Dev…

【求人No NJB2221377】
■ 職務内容 / Job Description
Clinical Scientist （CS） is a clinical project lead with strong experience in multidisciplinary aspects of drug development and is accountable/responsible for generating clinical development strategy designing clinical development options and delivering successful clinical development programs for responsible AZ assets in Japan.
His/Her accountability/responsibility is balanced between project level and study level activities depending on his/her experience and expertise in order to achieve deliveries of both projects and studies.

Other major responsibilities/accountabilities include but are not limited to:
・Co developing the documents for regulatory interactions such as BD for regulatory consultation query responses Sakigake application ODD application etc
・Authoring clinical/medical part of CTD and responses to queries
・Acting as a key point of contact for clinical development related relationship with external experts.
・Leading development of clinical science part of clinical trial documents and providing support for the Study Level Safety Review activity for Japanese standalone development projects
・Inputting to publication strategy and contents/quality of publications.

For more information about responsibilities/accountabilities refer to the full version of the Job Description for Clinical Scientist