Company Description Renesas is one of the top global semiconductor companies in the world. We strive to develop a safer, healthier, greener, and smarter world, and our goal is to make every endpoint intelligent by offering
POSITION SUMMARY Respond and attend to guest repair requests. Communicate with guests/customers to resolve maintenance issues with little to no supervision. Perform preventive maintenance on tools and equipment, including cleaning and lubrication. Visually inspect tools, equipment,
Minimum qualifications: Bachelors degree or equivalent practical experience. 15 years of experience serving in the capacity of a technical sales engineer in a cloud computing environment or equivalent experience in a customer facing role. Experience managing
We are Reckitt そのチカラを自由に使え。 今の自分を超えていけ。 FREE YOUR POWER. PROGRESS YOURSELF. Home to the worlds best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless
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
Position Summary: The Business Development Analyst will support Business Development activities in most tactical analysis, reports and business updates. Analyze new business opportunities and relationship with bottler’s teams, supporting sales and commercial team, responsible for business
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
Job Description In this role, you will be part of the AI & Cloud Engineering (ACE) Division and the Product Management team. ACE is developing a comprehensive AI strategy that delivers a highly flexible platform to
COMPANY OVERVIEW Global Atlantic Financial Group is a leader in the U.S. life insurance and annuity industry, serving the needs of individuals and institutions. Global Atlantic is a wholly-owned subsidiary of KKR, a leading global investment
Company Description Renesas is one of the top global semiconductor companies in the world. We strive to develop a safer, healthier, greener, and smarter world, and our goal is to make every endpoint intelligent by offering
Job Description *Hiring will be into all Renesas EMEA and APAC offices, either for hybrid work or remotely* In this role, you will be part of the AI & Cloud Engineering (ACE) Division and MLOps team.
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
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
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,
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
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
Requisition #: 14021 When visionary companies need to know how their world-changing ideas will perform, they close the gap between design and reality with Ansys simulation. For more than 50 years, Ansys software has enabled innovators
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
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
