Job Description: Business Overview To strengthen product categories and improve delivery quality, Rakuten Group is expanding its B-to-C businesses, which differ from the traditional marketplace model (Rakuten Ichiba). The EC First Party Development Department (ECFD) is Rakuten
Job Description: Business Overview Rakuten group has almost 100 million customers based in Japan and 1 billion globally as well, providing more than 70 services in a variety such as e-commerce, payment services, financial services, telecommunication,
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。
Hey there! We’re Fever, the world’s leading tech platform for culture and live entertainment. Our mission? To democratize access to culture and entertainment. With our proprietary cutting-edge technology and data-driven approach, we’re revolutionizing the way people
Marcus Evans is a global leader in business intelligence, helping our clients grow by making connections, sharing knowledge, inspiring people, building relationships, and creating new opportunities. With over four decades of experience and teams of highly experienced
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Job Description Purpose of the role To support business areas with day-to-day processing, reviewing, reporting, trading and issue resolution. Accountabilities Support various business areas with day-to-day initiatives including processing, reviewing, reporting, trading, and issue resolution. Collaboration
Job Description: Department Overview Rakuten Travel Experiences is a department responsible for operating “Rakuten Travel Experiences,” a rapidly growing new business within Rakuten Travel. Since the service launched in December 2021, we have been providing unforgettable travel
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Join our Team About us Ericsson is opening a state‑of‑the‑art R&D center in Yokohama focused on Radio and Software development. This new hub will support leading Japanese CSPs, partner with local vendors and deliver Japan‑driven products and solutions
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Who We Are Applied Materials is a global leader in materials engineering solutions used to produce virtually every new chip and advanced display in the world. We design, build and service cutting-edge equipment that helps our customers