Is now the right time for you to take your administration and business support experience to the next level? We are looking for someone who is passionate about their work, loves to be in a dynamic
About Us At Cloudflare, we have our eyes set on an ambitious goal: to help build a better Internet. Today the company runs one of the world’s largest networks that powers approximately 25 million Internet properties,
Company Description Visa is a world leader in payments and technology, with over 259 billion payments transactions flowing safely between consumers, merchants, financial institutions, and government entities in more than 200 countries and territories each year.
Your work days are brighter here. At Workday, it all began with a conversation over breakfast. When our founders met at a sunny California diner, they came up with an idea to revolutionize the enterprise software market.
Tulip, the Frontline Operations Platform, is empowering the world’s leading manufacturers to improve the productivity of their teams, the quality of their output, and the efficiency of their operations. With Tulip’s no-code platform, manufacturers can empower
Responsibility: バイオ品の新薬申請及び市販製品の変更管理におけるCMC薬事戦略を構築する バイオ品の新薬申請及び市販製品の変更管理におけるCMCのレギュラトリーリスクを時宜特定し、対応策を立案する 高品質のCMC承認申請資料を作成する。 規制当局からの照会事項に対してタイムリーな回答作成を行う。 バイオ品の新薬申請及び市販製品の変更管理におけるタイムリーな承認に寄与する 最新のCMC薬事情報の把握と規制当局及び業界への高い影響力を持つ。 Role: GSK Japanの開発品目におけるグローバル統一のCMC承認要件の実現かつ迅速な承認取得を目的としたCMC薬事戦略の構築、並びに市販製品の一部変更承認申請、軽微変更届出において、提言、方針決定、関連部署との交渉、必要に応じリソース配分等を自らも行い上司のサポートも行う。 当局対応において、承認時期への影響、GSKにおける承認後のグローバルビジネス及び国内での市販品の供給への影響等を鑑み、方針決定を行う、あるいはその提言を上司に行う。 他部署との協力業務におけるプロセス上の問題(役割分担等)の解決・調整をリードし、GSKとしてより良いプロセスを構築する、あるいはその提言を上司に行う。 複数の製品に共通のCMC関連課題/問題につき、海外関連部署と必要な協議を行う。 複数のproject team に対してCMC RA を代表したCMC薬事戦略の提案・提言を行う。 業界団体・学術団体等を通じCMCに関する規制調和を推進する。 Basic Qualification Skill 日本語又は英語により円滑なコミュニケーションのできる方 共に学びながら成長したい方 分析化学、有機化学または製剤・薬剤学(特に製造方法あるいはGMP)・生物学に関する知識がある方 Experience 企業での業務経験のある方(分析、製造、CMC薬事、開発等)(3年以上が望ましい) 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 Preferred Qualification Skill 英語環境での理論構築、読み書き、会話力等 Experience CMC薬事業務の経験 Why
Acquia empowers the world’s most ambitious brands to create digital customer experiences that matter. With open source Drupal at its core, the Acquia Digital Experience Platform (DXP) enables marketers, developers, and IT operations teams at thousands of global
Coach is a global fashion house founded in New York in 1941. Inspired by the vision of Creative Director Stuart Vevers and the inclusive and courageous spirit of our hometown, we make beautiful things, crafted to
Lectra Japan Ltd Sales Executive, Fashion INTRODUCTION We invite you to embark on a journey. A technological journey towards the evolution of our society and our industries, powered by Industry 4.0 and supported by Lectra. Software, equipment,
Job Requisition ID # 24WD78238 NOTE: This is NOT an open position. Please submit your CV here for future consideration. Position Overview At Autodesk, we believe that our success depends on our customers success, and we
This role required candidate to permanently relocate at Riyadh, Saudi Arabia. About the Company Founded in the late 1970s in Saudi Arabias oil-rich region, this multinational corporation has solidified its position as a global leader in the
Work Flexibility: Hybrid or Onsite Position summary: Work as part of the Network Services Integration team to deliver network infrastructure projects in line with identified requirements. Work with key stakeholders to ensure that all deliverables are
Job Purpose Background: Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. To achieve our ambitious goals,
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
About the job The Red Hat Open Innovation Labs team is looking for an Engagement Lead to join us in Tokyo, Japan. In this role, you will use a variety of modern application development practices, along
Fender Musical Instruments Corporation is a world famous brand with offices across the globe. An American icon, Fender was born in Southern California and has built a worldwide influence extending beyond the studio and the stage.
Who we are Are you looking for a dynamic career with excellent advancement potential at a global market leader? If so, consider Gartner, the worlds leading research and advisory company. Gartner delivers the technology-related insight necessary
Get to know Okta Okta is The World’s Identity Company. We free everyone to safely use any technology—anywhere, on any device or app. Our Workforce and Customer Identity Clouds enable secure yet flexible access, authentication, and
To get the best candidate experience, please consider applying for a maximum of 3 roles within 12 months to ensure you are not duplicating efforts. Job Category Finance Job Details About Salesforce We’re Salesforce, the Customer
Every great story has a new beginning, and yours starts here. Welcome to Warner Bros. Discovery… the stuff dreams are made of. Who We Are… When we say, “the stuff dreams are made of,” we’re not