Job Description: Department Overview Established in February 2026, the DX Solution Sales Section provides innovative DX solutions to our clients by leveraging the diverse assets of the Rakuten Group. Our offerings include SaaS solutions for mobile utilization,
Job Description: Business Overview Rakuten Group provides innovative services in the telecommunications and IT industries, aiming for growth in the global market. In recent years, we have been expanding our services for corporate clients, providing DX solutions
Responsibility: 変更提案に対する薬事影響評価(変更カテゴリ―、必要なデータ)の特定 市販製品(低分子医薬品及び/又はバイオ医薬品)の変更管理における薬事的なリスク低減策を含むCMC薬事戦略の立案・実行支援 薬事アクション(一変・軽変・相談・照会回答)に供する高品質な資料の適時作成 海外関連部署に対する本邦規制要件の提示・解説 (担当マネージャー)チーム成果物(提案・資料等)の品質保証(整合性、適切性) Role: 製造所の変更提案に対し適時薬事影響評価を行う。 市販製品の薬事アクション(一変・軽変・相談・照会回答)に対し、提言、方針策定の支援、海外を含む関連部署との交渉を行う。 薬事アクション(一変・軽変・相談・照会回答)に供する資料につき、海外薬事を含む国内外の品質部門と協働して資料作成を行う。 他部署との協業上の問題(役割分担等)の解決・調整を支援し、プロセス改善に寄与する、あるいはその提言を行う。 (担当マネージャー) チームメンバーの上記活動に対する能力開発を含めた指導・支援を行う。 関連部署との個別の課題/問題につき、必要な調整・解決のための協議を行う。 ※職務内容および勤務地の変更範囲は会社の定めるところとする。 Basic Qualification スキル Skill 分析化学、製剤・薬剤学・プロセス工学(特に製造方法あるいはGMP)等に関する知識 品質に関わる国内規制、各種ガイドライン及び日本薬局方などの知識 ロジカルシンキング(論理的に物事を整理し、本質を見極められる) 他者との緊密な協力関係を構築し、協業できること Word、Excel、PowerPoint、Outlook、 経験 Experience CMC関連業務(分析、製造、QA、CMC薬事など、関連業務5年以上が望ましい) CMC薬事経験必須、スタッフは関連業務経験の有無により以下を考慮することがある - 変更管理業務を含むCMC薬事への興味の高さ・習得意志の強さ - 業務に利用可能な傑出したスキル(例:英語がnative levelなど)またはコンピテンシー(自己認知・成熟性、変革行動、顧客志向性など)を1つ以上有する 学位/資格/語学力 Education/certification/Language 医学、薬学、生物学、物理科学等での学士もしくはそれと同等以上
Type de contrat : Travail temporaire- 6 mois Temps de travail : Temps plein Lieu: Tokyo Salaire: 1300 JPY (¥) - 1600 JPY (¥) / heure About Japan Experience Since 1981, weve been a leading tourism
Job Description: At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. We do this by driving Responsible Growth and delivering for our
Job Description: At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. We do this by driving Responsible Growth and delivering for our
Job Title: Remote Clinical Counselor This position is fully remote and candidates must be located in the OCOPAC region: Japan or Guam. All candidates must be flexible to work a shift within the hour range of
Job Description: At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. We do this by driving Responsible Growth and delivering for our
Company Description NBCUniversal is one of the worlds leading media and entertainment companies. We create world-class content, which we distribute across our portfolio of film, television, and streaming, and bring to life through our global theme
Industry leader? Well, how about an industry creator?! At WalkMe, now an SAP company, we’re not just the leader in digital adoption, we started the digital adoption revolution - enabling organizations to pinpoint and resolve digital
About Anthropic Anthropic’s mission is to create reliable, interpretable, and steerable AI systems. We want AI to be safe and beneficial for our users and for society as a whole. Our team is a quickly growing
ABOUT WIND RIVER Wind River is a global leader in delivering software for mission-critical intelligent systems. For more than four decades, the company has been an innovator and pioneer, powering billions of systems that require the
(English follows) 【部署の説明/ Description about the division】 以下のような役割を担っています。 ◎ECF(当社リスク管理の基本枠組み)の3つの防衛線の仕組みに基づく、独立した財務リスク等の評価(新商品、引受リスク管理、投資関連リスク管理、モデルバリデーションなど) ◎統合的リスク管理(ORSAなど) ◎リスク関連レポート、保険数理機能のレポート、保険リスク等に関するデータ分析(経験分析など) 【職務内容/ Job Description】 本人の能力、特性に応じて、部署の業務を広範に担当していただくことを想定しています。 1.3 Lines of Defense Model に基づく、セカンドラインの独立検証のうち、財務リスクに関する事項 2.ERM(統合的リスク管理)全般, リスク管理ガバナンス、NNグループとのコミュニケーションなど 3.データ分析やレポート 【入社後の教育・研修について/Education and Training after Joining the Company】 OJTに加え、アクチュアリー向けの教育・トレーニングの支援 【当該業務の魅力/ Selling Points of
Division Profile Fusion Response leads rapid and comprehensive Response and Recovery operations in order to minimize impact from a broad range of potentially business disrupting, to significantly impacting, threats and incidents, from cyber and fraud to
Job Description: Business Overview Ad & Media Company leads the Advertising Business, one of the core growth pillars of the Rakuten Group. By maximizing the power of the Rakuten Ecosystem and leveraging data and technology, we provide
Job descriptions may display in multiple languages based on your language selection. What we offer: At Magna, you can expect an engaging and dynamic environment where you can help to develop industry-leading automotive technologies. We invest
Blackstone is the world’s largest alternative asset manager. We seek to create positive economic impact and long-term value for our investors, the companies we invest in, and the communities in which we work. We do this
You desire impactful work. You’re RGA ready RGA is a purpose-driven organization working to solve today’s challenges through innovation and collaboration. A Fortune 200 Company and listed among its World’s Most Admired Companies, we’re the only
About Equativ Founded in 2001 in Paris, Equativ has grown into a global independent ad tech platform enabling advertisers and media owners to achieve better business outcomes through programmatic, CTV, and retail media solutions. Backed by
SummaryAbout Kering Kering is a global, family-led luxury group, home to people whose passion and expertise nurture creative Houses across couture and ready-to-wear, leather goods, jewelry, eyewear and beauty: Gucci, Saint Laurent, Bottega Veneta, Balenciaga, McQueen, Brioni,