Principal Biostatistician / Programmer Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our
Medical Affairs is a key organization of scientific excellence that contributes to transform treatment landscape and ease of access to cares by generating critical clinical evidence and educating relevant science to external or internal customers/stakeholders. All
This is what you will do: The Senior Manager, Regulatory Affairs-Chemistry, Manufacturing, and Controls (RA- CMC) in Japan will manage complex projects for CMC submission in Japan and responses to regulatory agency inquiries for Alexion’s commercial
Company Description Keywords Studios is a global provider of creative and technical services to the video games industry, with over 13,000 professionals across 70+ studios in 25+ countries. We support clients across the entire game lifecycle
Company Description Start Date: January-June 2026 Want to accelerate your career in a high-energy, commercial role? If you’re competitive, a confident communicator, both on the phone and in person, and hungry to grow fast, our Associate
Company Description Start Date: January-June 2026 Want to accelerate your career in a high-energy, commercial role? If you’re competitive, a confident communicator, both on the phone and in person, and hungry to grow fast, our Associate
Company Description Keywords Studios is a global provider of creative and technical services to the video games industry, with over 13,000 professionals across 70+ studios in 25+ countries. We support clients across the entire game lifecycle
PURPOSE & OVERALL RELEVANCE FOR THE ORGANIZATION Orchestrate cross-functional product creation teams across apparel, accessories, and footwear to deliver the category vision to target consumer groups across all creation layers and distribution channels. End-to-end ownership and
Implementation Manager, Japan | Make Every Implementation a Success Story. Love technology and love delivering results? Are you a project leader ready to join a fast-moving growth company transforming the way the worlds businesses travel? At
Location:Tokyo, Tokyo, Japan Job ID: R0125575 Date Posted:2026-06-10 Company Name:HITACHI ENERGY JAPAN, LTD. Profession (Job Category):Engineering & Science Job Schedule: Full time Remote:No Job Description: The opportunity Hitachi Energy Service is a trusted lifecycle partner, providing
Basic Purpose of the Job The Clinical Trial Manager (CTM) is accountable for the operational and scientific oversight, set-up, execution and delivery of assigned clinical trials at the Japan level. Key responsibilities: Accurate planning and efficient
Creative Production Manager - Pokémon GO The Pokémon GO Marketing team is seeking a Creative Production Manager to drive growth through comprehensive Marketing strategies across both owned channels and paid media. This role will lead the
The Japan Project Head (JPH) would be responsible for overall Japan development strategy for vaccine project in alignment with Global project strategy as well as Sanofi R&D strategy and business objectives. The JPH is accountable for
You desire impactful work. You’re RGA ready RGA is a purpose-driven organization working to solve today’s challenges through innovation and collaboration. A Fortune 200 Company and listed among its World’s Most Admired Companies, we’re the only
Purpose & Overall Relevance for the Organization Drive, manage and deliver the Go To Market (GTM) strategy against global priorities; lead category management team to bring the strategy to life as well as manage local team
Role Summary: We are seeking a proactive and results-driven Project Manager to oversee critical initiatives supporting Jefferies’ expansion in Japan. This role emphasizes strategic oversight, hands-on problem-solving, and strong leadership to ensure successful delivery of complex,
Project Manager, FSA - Tokyo Osaka - Office Hybrid Home ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven
As the VP of Robotic Foundation Model, you will lead the strategy, organization, and technical execution of our robotics foundation model team. This role is responsible for building and managing the team that turns that advancing
The Opportunity The customer is the focus of everything we do, and millions of end users rely on our products daily. We believe in the value of empowering Project Senior Analyst with the resources to solve
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。