At Dow, we believe in putting people first and we’re passionate about delivering integrity, respect and safety to our customers, our employees and the planet. Our people are at the heart of our solutions. They reflect
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
Company Description Who is Turner & Townsend? All over the world people are using buildings, infrastructure, and assets we helped to deliver. It could be the hospital they work in, the railway they travel on every
7/7 days only roster | FIFO from Perth to the Roy Hill Mine Competitive salary and three annual bonus schemes Benefits include income and life insurances, health, banking, car leasing, airline + travel, IT discounts Family friendly
Let’s be #BrilliantTogether Are you looking to grow your career with a formal career path at an established, respected, global leader? Do you want to join an intellectually rich, driven, inclusive environment with a culture of
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
企業概要 Digitas is The Connected Marketing Agency of Publicis Groupe - committed to helping brands better connect with people through strategy, design and data excellence. Overview Digitas, The Connected Marketing Agency of Publicis Groupe, is seeking
【Job Purpose】 Business Development Director is responsible for developing new businesses in mobile Device Lifecycle Solutions (DLS) with assigned clients, turning efforts into closure of new deals, and achieving financial goals for assigned clients. 【Primary Job
The successful candidate will play a critical role in our Information Security Management System project and compliance activities across the organization Responsibilities Contribute to the ISO27001 certification project and compliance activity across the organization by implementing
Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions
Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions
Company Description Publicis Groupe is not just a company you work for; it’s a platform for you to take your talent to the world. If you want to help change the world, ideas alone are not
Introduction The sector of Customer Support (CS) is responsible for the maintenance, repair and continuous improvement of ASML systems at customer locations, as well as transferring. Job Mission The mission of the DUV Field Service Engineer(FSE),
Job Description: Details of the Division and Team: The role is for an Auditor level position to join an established audit team in Japan and contribute to the diversification of the team’s coverage across Japan and
Our Company Changing the world through digital experiences is what Adobe’s all about. We give everyone—from emerging artists to global brands—everything they need to design and deliver exceptional digital experiences! We’re passionate about empowering people 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
Company Description At ServiceNow, our technology makes the world work for everyone, and our people make it possible. We move fast because the world can’t wait, and we innovate in ways no one else can for our
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 unique
Requisition ID: 200162 Join a purpose driven winning team, committed to results, in an inclusive and high-performing culture. What your role will be. Customer Relations Representative As a member of the Dealer Finance Centre (DFC) Team
