Minimum qualifications: Bachelors degree or equivalent practical experience. 10 years of experience in the IT industry, including 5 years of experience in the cloud industry. Experience building partner ecosystems for partners, mid-market integrators, cloud integrators, specialized
The GCDSE provides clinical and R&D expertise, guidance and direction in the context of the region/country, in which they operate. As the leader of the Clinical (or Extended Clinical) Team, the GCDSE is the clinical representative
Join the VRChat Team! VRChat offers a first-of-its-kind, game-changing platform that provides an endless collection of social VR experiences and gives the power of creation to its robust community. With over 250,000 worlds and growing, VRChat’s
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
Get to know us Ideals is a global B2B SaaS product company recognized as the most highly rated and customer-centric brand in the secure business collaboration market. Trusted by over 2,000,000 users from 300,000 companies globally,
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
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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。
Clinical Development Lead (CDL) is responsible for the overall Japan clinical development plan for assigned projects. CDL ensures studies are designed to fit Japan specific requirement and situation from clinical, regulatory, and operational perspectives. CDL is accountable for
Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring
Business Development Manager, Japan | Your Next Big Win Starts Here. Love travel and love winning? Are you a driven sales professional ready to join a fast-moving growth company transforming the way the worlds businesses travel? At
Job Details: Job Description: Supports management/senior leadership to incorporate process and quality improvements in Intels supply chain strategy. Defines material inspection methodology, conducts studies related to cost control, process control, and production yield, and implements plans
Senior Business Development Manager - Japan Convera make moving money easy…so easy that any organization in the world can grow with confidence. We are looking for an experienced business development & account management lead to join the Japan
Welcome to the future of cloud networking and security! Cato Networks is the first company to converge enterprise networking and security into one centralized and global service that is delivered by cloud. It is led by
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
Minimum qualifications: Bachelors degree or equivalent practical experience. 7 years of experience in business development, partnerships, management consulting, or investment banking. Experience working with C-level executives and cross-functionally across all levels of management. Experience managing agreements or
About this role Business: Global Product Solutions (“GPS”) was formed with the mission to innovate, curate and commercialise the full breadth of our investment platform for what our clients need, wherever they are. The function is
Senior Medical Writer - Office Hybrid Tokyo Osaka Full Remote 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
Company Description The Averna experience Averna delivers industry-leading test solutions and services for communications and electronics device makers worldwide, accelerating product development, quality and innovation: Be global@work: Serve international customers and collaborate with colleagues in Canada, Europe,
PURPOSE & OVERALL RELEVANCE FOR THE ORGANISATION Lead the planning and execution of culture marketing partner management and activation ranging from celebrities, artists and fashion designers within Japan, to contribute to the growth of lifestyle business.