The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, youll be
Summary Posted: May 24, 2024 Role Number: 200552865 Imagine what you could do here. At Apple, new ideas have a way of becoming extraordinary products, services, and customer experiences very quickly. Bring passion and dedication to
DESCRIPTION Learn how “the cloud” works and how to keep it running as an Amazon Web Services (AWS) Data Center Operations (DCO) Trainee. In Amazon’s mission to be Earth’s most customer-centric company, DCO maintain the highly
Find what drives you on a team with a more than 75-year history of discovery, determination, and innovation. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers solve
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 laboratories,
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 laboratories,
Mapbox is the leading real-time location platform for a new generation of location-aware businesses. Mapbox is the only platform that equips organizations with the full set of tools to power the navigation of people, packages, and vehicles
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 望ましい条件
About this role The Aladdin Client Services (ACS) Team tackles the hardest, most sophisticated problems in FinTech. We utilize our in-depth understanding of Aladdin, our clients’ businesses, and the investment management process to provide world-class customer
intelliflo is a global business that welcomes bold ideas and all points of view. Doing what matters inspires us, and we believe that we grow best – as people and businesses - by working together and
The Role This position will provide administrative support to the PM Team in theGroup. Job Responsibilities プロパティマネージャーの下で下記業務のサポート。（Mapletreeのシステムを使用） ➢ 請求書発行関連業務 ➢ 月次PMレポート作成補助業務 ➢ 修繕工事等発注業務（注文書作成/発行等、社内事務手続き） ➢ 費用支払申請関連業務 ➢ 社内経費精算業務 ➢ その他簡単な書類作成業務 ➢ ファイリング（建物関連資料、各種契約書、報告書、社内書類等、電子フィル含む。） ➢ 庶務（ミーティング手配・バイク便手配・来客・電話対応、コピー、PDF作成保管、スタッフの出張手配等） • Support overall
Mapbox is the leading real-time location platform for a new generation of location-aware businesses. Mapbox is the only platform that equips organizations with the full set of tools to power the navigation of people, packages, and vehicles
When applying for roles at Tealium, please use our official careers page or LinkedIn company profile. All other sites where Tealium careers may appear may not be legitimate. WHO WE ARE Tealium is the most trusted
Job Description: *This position may be transferred to Rakuten Edy, Inc. ■Mission Our mission is to contribute to the further development of the business by creating, operating and operating a framework for accounting and finance-related operations
Media.Monks is on the lookout for a Senior HRIS Integrations Engineer. What you’ll be doing. Lead the design, development, and implementation of Workday integration solutions to meet business needs. Oversee integrations with tools including Greenhouse, CompAnalyst,
About us InterContinental Hotels Group are one of the worlds leading hotel companies. Present in around 100 countries, we have over 914,900 rooms in over 6,170 hotels. Youll know our hotel brands. They are some 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. Responsible Growth is how we run our company and how we deliver
About this role Your team Were seeking a talented individual to join Aladdin Client Transformation team in Asia Pacific, as implementation consultant. As part of the BlackRock family, eFront is experiencing exciting growth and development. Our
Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves to
The Customer Project Execution department is responsible for the overall execution of the Wind Farm from delivery of components, BOP Electrical & Civil Works, Installation & Commissioning works and testing, up to handing over of the
