This position will be the primary technical point of contact for the API SM OpU with external Contract Manufacturing Organizations. The primary role will be to provide scientific and technical expertise for all drug substance related activities ensuring that new and existing drug substance technology and related processes procedures and specifications are developed and transferred to our contract manufacturing operations （CMOs） in a manner compliant with all regulatory and quality standards and supports cost effective technical processes suitable ...
・Leads the regulatory working team for Japan and represents as needed at project team and ensures regional regulatory lifecycle management strategy and submission planning written and executed according to plan ・ or oversees if delegated and/ or vendor.
・Partner with the Japan market access and to understand market access and reimbursement topics and support opportunities to drive consolidated inputs into Japan product development plans.
・For the project（s）/product（s） of responsibility collaborates with Global and Regional ...
Main responsibilities are to collaborate with representatives from other functions to plan execute analyze and report for relevant studies as a statistician for clinical studies mainly conducted in Japan such as Ph I to Ph IV studies post marketing surveillance and medical affairs company sponsored study.
・Contribute to the development of the study protocol
・Develop the statistical analysis plan
・Produce the statistical deliverables
・Input statistical insights to interpret the study results
2.Quantitative Systems Pharmacology：臨床・非臨床試験（薬理学、薬物動態学、オミックスなど）から得られたデータに基づいたモデリング＆シミュレーションによる、臨床薬効・副作用の定量的予測とそれに基づく最適プロト ...