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
Would you like to be part of a team shaping the future of the IT industry through responsible and innovative use of Artificial Intelligence? Amazon Web Services (AWS) is advancing the next evolution of cloud computing
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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
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
About Airwallex Airwallex is the only unified payments and financial platform for global businesses. Powered by our unique combination of proprietary infrastructure and software, we empower over 200,000 businesses worldwide – including Brex, Rippling, Navan, Qantas,
Job Description Summary: Director, Category Finance & Investment Management - Coca-Cola, SCM and Productivity Reports to: Senior Director, Investment Management (Based in Tokyo, Japan) Location: Tokyo, Japan This role will act as one of the key
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Job Description Summary: Job Description Summary Drive Alcohol brands business growth through strategy and execution planning to build brand equity and deliver short and mid/long-term growth targets. Drive Alcohol brands’ initiatives such as new product development,
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
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