Required Vestas Offshore Service Readiness and Support Department, is part of the overall Offshore Service business in the APAC region, working closely with the Operational Service Team, Sales, Special Projects and Construction. Responsible for the service
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
Work Flexibility: Hybrid or Onsite Who we want: • Hard-working winners. Confident, competitive and results-oriented professionals who create a track record of success. • Dedicated achievers. People who thrive in a fast-paced environment and will stop
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
THE COMPANY and BUSINESS Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a is a global, integrated healthcare services and products company, providing customized solutions for hospitals, health systems, pharmacies, ambulatory surgery centres, clinical
The candidate should have electricity , instrument and DCS engineering capability for project execution RESPONSIBILITIES Contribute to the analysis of information, the specification of the methods, process steps, and the plant, machinery and equipment required to
職務の目的および主な業務内容 Job Purpose & Key Responsibilities VEO Expertは、担当品目のValue Evidence Planの作成および実行に責任を持ちます。Evidence needsおよびGapを評価し、製品価値を高めるための最も適切な試験計画を組織横断チームにて立案し、提案していきます。 VEO Expert contributes to develop Japan Value Evidence Plan (J-VEP) of the assigned products. VEO Expert plan, implement and deliver high quality, scientifically robust research
職務の目的 開発品目の承認申請時の添付文書案作成等： 薬事規制及びGSKポリシーに従い、申請内容に基づく添付文書案作成においてプロジェクトチームをリードする。 CCDSに基づく添付文書の記載事項が承認されるよう、承認審査における添付文書関連照会事項に対する回答作成をリードする。 市販品目の添付文書管理： 薬事規制及びGSKポリシーに従い、最新の情報に基づく添付文書の改訂及び改訂添付文書の公開を滞りなく行う。 添付文書に係るカスタマーからの問い合わせに対して適切に回答する。 アートワーク管理： 必要な薬事Inputを行い、アートワークの変更及び製品への封入切り替えが滞りなく行われるように取り計らう。 市販後薬事： 市販品目のライフサイクルマネジメント（主にCMCの変更管理）に関連し、規制当局及び社内関連部署と良好な関係を築き、規制当局との窓口業務を適切に遂行する。 主な業務内容 承認申請資料（添付文書案含む）の作成・改訂 承認申請時の添付文書案作成における取りまとめ 承認審査時の添付文書関連照会事項に対する回答作成 添付文書改訂相談における当局窓口 添付文書改訂版の校正 添付文書の届出 PMDA 公開サイトの企業ページ管理・必要情報の登録・公開 添付文書に係る外部問合せに対する回答 患者向医薬品ガイドの作成・改訂、当局への改訂相談、公開 市販品目の変更管理に関する薬事業務 業許可管理の業務 当局対応での、承認時期への影響や承認後のグローバルビジネス及び国内での市販製品の供給への影響等を鑑みた方針決定 業界団体・学術団体等を通じた薬制に関する規制調和の推進 ライフサイクルマネジメントに関連する市販後薬事の業務全般におけるタイムライン管理、薬事的課題の把握及び解決策の提案、当局交渉等のマネジメント 必要な条件 医薬品開発、薬事関連業務、変更管理業務あるいは安全性管理業務の経験 海外とメール又は口頭でコミュニケーションができる英語力 当局関係者と交渉するためのコミュニケーション能力 基本的なITスキル（Word, Excel, Power Point等） 向上心があり、変革に対して前向きであること
About Us Always open. Our code, our culture, our opportunities. Leading open innovation without limits. We are SUSE. SUSE is a global leader in innovative, reliable and secure enterprise open source solutions, including SUSE Linux Enterprise
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
Range Operations Specialist The Opportunity: As an expert in defense missions, your unique skill set inspires you to think bigger, push further, and ask questions others don’t. We need your extensive industry knowledge and advisory skills
Account Manager This role has been designed as ‘’Onsite’ with an expectation that you will primarily work from an HPE partner/customer office. Who We Are: Hewlett Packard Enterprise is the global edge-to-cloud company advancing the way
パートナー営業（ディストリビューター担当） This role has been designed as ‘’Onsite’ with an expectation that you will primarily work from an HPE partner/customer office. Who We Are: Hewlett Packard Enterprise is the global edge-to-cloud company advancing the way people
The Technical Sales Management department is the regional arm of our global Technical Sales Organisation, which links our Business Unit and our customer needs towards the central Power Solutions Team, responsible for the global Product Development
There is a place for you at T. Rowe Price to grow, contribute, learn, and make a difference. We are a premierassetmanagerfocused on delivering global investment management excellence and retirement services that investors can rely on today
Services Experience Delivery Japan Geo Leader This role has been designed as ‘’Onsite’ with an expectation that you will primarily work from an HPE office. Who We Are: Hewlett Packard Enterprise is the global edge-to-cloud company
LSEG Data and Analytics equips the financial community with access to an open platform that uncovers opportunity and catalyzes change. With a dynamic combination of data, insights, technology, and news from Reuters, our customers can access solutions
About the Role: Grade Level (for internal use): 09 Consultant, Energy Consulting – Tokyo Job Summary Todays global energy landscape is interconnected and dynamic. Energy Consulting from S&P Global Commodity Insights comprise some of the most
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. Responsible Growth is how we run our company and how we
