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
About Agoda At Agoda, we bridge the world through travel. Our story began in 2005, when two lifelong friends and entrepreneurs, driven by their passion for travel, launched Agoda to make it easier for everyone to
About Agoda At Agoda, we bridge the world through travel. Our story began in 2005, when two lifelong friends and entrepreneurs, driven by their passion for travel, launched Agoda to make it easier for everyone to
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 Flexport: At Flexport, we believe global trade can move the human race forward. That’s why it’s our mission to make global commerce so easy there will be more of it. We’re shaping the future of
Come join the organization that is redefining security for the AI era. As one of the fastest-growing startups ever, we enable teams to secure cloud and AI applications by connecting code, cloud, and runtime into a
Job Overview: The Senior CRA I is responsible for site monitoring and site management. Responsibility for clinical studies according to Fortrea, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. The Senior CRA I assure the implementation of
Job Overview: Role is primary contact for investigative sites for site payments. Responsible for administering grant and non-grant payments in accordance with the site executed agreement. Summary of Responsibilities: Accountable for the overall payment management of assigned
Job Overview: Prepares and negotiates and assists in the execution and retention of site agreements, confidentiality agreements, letters of indemnification and other contracts for Sponsors who contract Fortrea to perform this service. Maintains and contributes to
We are looking for an intern to support our office operations and back-office activities! Responsibilities Office and General Affairs Support Manage office supplies, pantry items, and help maintain a comfortable office environment Support PC setup and
Job Description SummaryシニアGPRM-Jとして、医薬品の開発段階から市販後に至るまでの薬事戦略を主導・支援し、日本における最適な承認取得および製品維持を実現する。日本およびグローバルの規制環境に精通した専門性を活かし、PMDA等の規制当局との信頼関係を構築するとともに、クロスファンクショナルおよびグローバルチームと連携し、ノバルティスの事業価値最大化に貢献する。また、業界活動や後進の育成を通じて、ノバルティス・ジャパンのリーディングカンパニーとしての地位確立を支える。 Job Description 業務内容: 医薬品の初期開発段階からプロジェクトチームに参画し、承認取得までの期間を通し、薬事戦略の立案、それに基づく開発プランの作成について中心的な役割を果たし薬事的リスクマネジメントを行う。 規制当局(PMDA, MHLW) 対応をリードし、プロジェクトチームの代表として関係当局との交渉に責任を持つ。例:開発プロジェクトの承認申請チームのリード Globalと協同し、世界同時開発・同時申請・同時承認の達成をドライブする。 各部門の担当者等と協働し、Product Life Cycle Planの最大化に貢献する。 業務のやりがい: 開発早期から承認取得、市販後まで薬の一生に幅広く関わることができる 規制や業界の流れを正しく読み取り、将来的な変化を見越した薬事戦略の立案/実行をリードできる 社内外の顧客や海外の開発関連部署など多くのメンバーと多岐にわたる仕事に携われる 個人としての作業に加えて、チームメンバーとの協働を通じて、申請・承認などの大きなマイルストーンも経験できる 社内外や規制当局も巻き込んで、AIやITテクノロジーを活用した先進的な医薬品開発を推進していくイノベーティブな活動にも参画できる 求められる主なスキル・経験: 1.開発薬事に関わる知識,経験 –医薬品開発,薬事規制に関する全般的な知識経験 –規制当局との折衝経験 2.コミュニケーション・ネゴシエーション・プレゼンテーション –社内の他部門との調整 –規制当局との折衝・交渉 –マネジメントへの報告 3.プロジェクトマネジメント –進捗管理,会議運営,記録作成等 4.リーダーシップ –規制当局対応、承認申請チームのリード 5.英語 –マネジメントへのレポートの作成・説明,global memberとの電話会議等の機会があるため,業務に支障が出ない程度の英語力が必要になります。
Job Description We are seeking a Transfer Pricing manager to oversee the execution of our global intercompany pricing strategies. You will ensure that our cross-border transactions are compliant with OECD guidelines and local regulations, while working
Enterprise Technology Solutions - Pre-Sales Technology Engineer - Tokyo Location Tokyo Business Area Sales and Client Service Ref # 10052045 Description & Requirements Bloomberg delivers critical information in a world where information matters. We give influential
CTM I/II Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate
We are a leading trading platform that is ambitiously expanding to the four corners of the globe. Our top-rated products have won prestigious industry awards for their cutting-edge technology and seamless client experience. We deliver only
About Agoda At Agoda, we bridge the world through travel. Our story began in 2005, when two lifelong friends and entrepreneurs, driven by their passion for travel, launched Agoda to make it easier for everyone to
JOB SUMMARY 日本語スキル必須 / Japanese language skill is a must. The HR Manager directs and works with Human Resources and Operations employees to carry out the daily activities of the Human Resource Office including oversight of
About Four Seasons: Four Seasons is powered by our people. We are a collective of individuals who crave to become better, to push ourselves to new heights and to treat each other as we wish to
Role Overview As an engineer at Telexistence, you will not only design, develop, and maintain the core backend services for our robotic operations management system but also owns the end-to-end lifecycle of a product capability, from problem