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
Company Description Turner & Townsend is a global professional services company with over 22,000 people in more than 62 countries. Working with our clients across real estate, infrastructure, energy and natural resources, we transform together delivering
What if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of
About the Role: Grade Level (for internal use):09 The Sales Development Representative (SDR) is a critical entry point into our commercial organization and a core component of our centralized Revenue Associate Program. Positioned at the forefront of
Why PlayStation? PlayStation isn’t just the Best Place to Play — it’s also the Best Place to Work. Today, we’re recognized as a global leader in entertainment producing The PlayStation family of products and services including
Overview We are looking for a motivated and coachable Sales Development Representative (SDR) to join our Japan Go-to-Market team. In this role, you will be the first point of contact for prospective customers, responsible for generating qualified
部署紹介/Business Unit当社の「クラウド＆スマート・インダストリー・グループ（CSIG）」は、クラウドおよびインダストリー・インターネット戦略の推進を担い、クラウド技術、AI、ネットワークセキュリティの進化を通じて、スマート産業の革新的なソリューションを生み出しています。CSIG は、小売、医療、教育、交通など多様な産業のデジタル化を推進しながら、企業がより効率的にユーザーにサービスを提供できるよう支援しています。また、企業とユーザーを結びつける新たなインテリジェント産業エコシステムの構築にも取り組んでいます。 Cloud & Smart Industries Group (CSIG) is responsible for promoting the companys cloud and industry Internet strategy. CSIG explores the interactions between users and industries to create innovative solutions for smart industries via
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms
Job Posting Title:Manager, Corporate Strategy & Business Development Req ID:10156935 Job Description: Wherever you are in the amazing world of Disney, you are contributing to the stories of our iconic brands, recognized by audiences everywhere for entertainment,
JD in Japanese follows. 英文の後に和文JDをご覧いただけます。 Research Program Manager - Mercari Employment Status: Full-time Work Hours:Flextime (no core hours) Office:Roppongi, Osaka, Fukuoka For more details, see the Overview of Our Positions section on our Careers site. About Mercari
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NVIDIA has been transforming computer graphics, PC gaming, and accelerated computing for more than 25 years! It’s a unique legacy of innovation that’s fueled by great technology—and amazing people. Today, we’re tapping into the unlimited potential
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Job Description: Business Overview Rakuten is one of the leading E-commerce companies in the world. Our mission is to empower people and society through the internet while aiming at becoming the Global Innovation Company. Department Overview