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
General Information Job Advert Title: Scientist, Downstream Bioprocess Science, CBTL, Product Research & Development Location: Tsukuba, Ibaraki Division: Product Research & Development Employment Class: Permanent Description 【募集の背景 / Purpose & Scope】 Downstream Bioprocess Science Lab (DSBP) in Chemical & Biological
General Information Job Advert Title: Scientist, Analytical Research 3, Analytical Research Labs, Product Research & Development Location: Tsukuba, Ibaraki Division: Product Research & Development Employment Class: Permanent Description 【募集の背景 / Purpose & Scope】 The Analytical Research Laboratories support pharmaceutical research and development through analytical sciences
General Information Job Advert Title: Drug Substance Lead, Upstream Bioprocess Science, CBTL, Product Research & Development Location: Tsukuba,Ibaraki Division: Product Research & Development Employment Class: Permanent Description 【募集の背景 / Purpose & Scope】 Astellas Pharma’s Product Research & Development (PR&D) organization, including Chemical
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Role Summary The clinician contributes towards providing medical and scientific expertise and oversight for Clinical Trials conducted worldwide with a primary focus in Japan and the Asia-Pacific region. The clinician may be required to design a
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
Sales Development Representative Hybrid Tokyo, Japan The world of payment processing is rapidly evolving, and businesses are looking for loyal and strategic partners, to help them grow. Meet Nuvei, Nuvei is the global fintech building the infrastructure
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About the OpportunityJob Type: Permanent Application Deadline: 28 September 2026 Job Description Title Research Analyst Department Research Location Tokyo, Japan Reports To Director of Research Level Grade 7/8 We’re proud to have been helping our clients build better financial
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Why Headout? We’re a rocketship: 9-figure revenue, record growth, and profitable With $200M+ in revenue, guests in 700+ cities, and 18 months of profitability, Headout is the fastest-growing marketplace in the travel industry, and we’re just
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OVERVIEW ISS STOXX is a global leader in corporate governance research, data, and analytics, supporting institutional investors in managing stewardship and voting responsibilities. We are seeking an experienced Associate Director to lead our Korea Governance Research team, based
Job Title: Technical Sales & Business Development Manager Territory: Japan and Korea Job Overview: The Technical Sales & Business Development Manager is responsible for accelerating the growth of Howmet Fastening Systems industrial products business in Japan and Korea
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
Our vision is to transform how the world uses information to enrich life for all. Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring
Who is Sonar? Sonar is driving the future of agent-centric software development. As the leader in AI code verification and governance, we solve a critical problem: ensuring that software generated by AI-assisted developers or autonomous agents is