１．主な職務における成果責任/ Description of Primary Role & Responsibility Summary ■ 日本における医薬品の承認申請業務（非臨床3パート：薬理、動態、毒性） ■ 薬事関連資料（IB, CTDなど）の作成及び当局からの照会事項、対面相談の対応等 ■ Global部門の開発戦略に基づいた、日本での非臨床研究開発戦略の立案と実行 ■ 非臨床研究開発の専門分野における日本における情報発信 ■ 日本のサイエンスの現状を調査・情報収集し、Global非臨床研究開発部門にOpen Innovationとして紹介、共同研究の機会の構築 Responsibilities ■ 日本における医薬品の承認申請業務（非臨床3パート：薬理、動態、毒性） 日本の開発プロジェクトチームに非臨床(3パート)の専門家として参画し、プロジェクトにおける専門的科学知識やノウハウを提供 開発ターゲットにおける科学的知識、競合や規制ガイドラインの情報を把握 プロジェクトの進捗状況、可能性のある障害等を把握、チームに発信する Globalで実施されている非臨床試験の進捗をモニターし、チームに情報を提供する 非臨床関連の規制ガイドラインに関する専門家としてファイザーDJ（研究開発部門）およびファイザーJapanに対して、貢献する プロジェクトに関わる規制当局（PMDA等）との会議にDSRDの代表として参加する ■ 薬事関連資料（IB, CTDなど）の作成及び当局からの照会事項、対面相談の対応等 非臨床に関連する規制文書（PMDA相談、CTPN,CTDなど）を作成しGlobal担当者と協力してPMDAの質問に対応する グローバル規制文書に、日本での規制を適応させ包括的な非臨床評価を行う 文書のレビュー等を含めて、非臨床分野の規制文書の作成をタイムラインに合わせて実施する Globalの担当者と協力して、日本の基準に基づいた規制文書のコンテンツ、フォーマットに責任を持つ
■ 職務内容 / Job Description 【Responsibility/Key Tasks 】 HEOR director is a leadership member of Evidence and Observational Research (EOR) and leading HEOR team as a head of HEOR. Accountabilities Establish HEOR organization and ensure the
SummaryWe bring amazing people together to make amazing things happen. We’re a diverse collective of thinkers and doers, continuously reimagining our products and practices to help people do what they love in new ways. That innovation
Introduction At IBM Research, we are the innovation engine of IBM. Exploring what’s next in computing and shaping the technologies the world will rely on tomorrow. From advancing AI and hybrid cloud to pioneering practical quantum computing,
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Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring
Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring
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