【募集の背景 / Purpose & Scope】

The position has responsibility for nonclinical safety profiling and characterization of development candidates, implementing nonclinical safety data packages (including plan, execution, outsourcing, and evaluation of toxicity studies), documentations, and regulatory responses, and for enabling regulatory interactions, while reporting to Applied Safety (AS) Head/AS-JP Head, Applied Research & Nonclinical Safety (ARNCS).

【職務の内容 / Essential Job Responsibilities】

（雇入れ直後）

・Execute nonclinical safety program management:

-Preparation of nonclinical safety development plans

-Provision of nonclinical safety information to global PJ teams

-Preparation of nonclinical safety sections of Investigator Brochures, Briefing Documents, INDs and NDAs, and responses to queries from regulatory authorities

・Collaborate closely with other internal stake holders to make rational decisions to achieve clinic...