SCOPE AND RESPONSIBILITIES: -FP&A Manager performs a variety of reporting job for Beckman Coulter Japan (total about 900 employees with a few hundred million USD sales).The person will provide business planning and analysis which is eventually
職務の目的および主な業務内容 Job Purpose & Key Responsibilities VEO Expertは、担当品目のValue Evidence Plan (VEP)とIntegrated Evidence Plan (IEP)の内容の企画・策定 およびその計画の実行に責任を持ちます。Evidence NeedsおよびGapを評価し、製品価値を高めるための最も 適切な試験やデータベース研究の計画を組織横断チームにて企画・立案・提案し、その実行とEvidenceの公表 までの広い責任と職務をリードしていきます。 また、ワクチン領域においては、定期接種や自治体の予防接種補助金の根拠となるCost Effectivenessモデルの構築やその推定結果をEvidenceとして公表すること、ならびに臨床開発早期の段階にある製品Pipelineに 対して、日本やアジアの疫学的な視点から助言し、承認取得までの臨床開発計画におけるEvidence Gapを 評価し、製品Launchの前後に必要な最適なVEP/IEPを企画・立案・提案することが求められます。 The VEO Expert contributes to plan, develop and execute Value Evidence Plan (VEP)
Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves
Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including
We are seeking an experienced Consultant for our global Academic & Government practice to design, conduct and manage innovative quantitative analyses for program evaluation, science management and research assessment. With a focus on North APAC, bringing the
Woven by Toyota is the mobility technology subsidiary of Toyota Motor Corporation. Our mission is to deliver safe, intelligent, human-centered mobility for all. Through our Arene mobility software platform, safety-first automated driving technology and Toyota Woven
Job Description *Hiring will be into all Renesas EMEA and APAC offices, either for hybrid work or remotely* In this role, you will be part of the AI & Cloud Engineering (ACE) Division and MLOps team.
Company Description Renesas is one of the top global semiconductor companies in the world. We strive to develop a safer, healthier, greener, and smarter world, and our goal is to make every endpoint intelligent by offering
Head of Supply Chain Location: Tokyo Hiring Manager: Carol Chan About the job Key Tasks and Accountabilities Lead the IBP process in Japan to best-in-class standards to ensure that sales and profitability targets are achieved. Drive
Our Company Changing the world through digital experiences is what Adobe’s all about. We give everyone—from emerging artists to global brands—everything they need to design and deliver exceptional digital experiences! We’re passionate about empowering people to
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
Job Description SummaryJob Overview With global impact and oversight, manage a department of Biostatistics and Statistical Programming staff ensuring that target productivity (project allocations, utilization, and output) levels are met. May fulfill the role of site
Japanese company with global footprint is looking to hire Android Developers to support projects around their mobile applications. Required Qualifications: - Collaborate with Product Managers, UI/UX Designers and QA Engineers to build new features. - Work
* We are seeking a fluent Japanese and business-level English-speaking EDC System Implementation Specialist with clinical programming expertise to join our biometrics specialized CRO client, partnering with Japanese pharmaceutical companies. This remote role offers a competitive
The statistical analyst provides strong leadership in the process of drug development, by preparing CDISC complied databases, statistical summary table/figures in accordance with a schedule. 企業情報 * 外資製薬会社 * イノベーション:研究開発への投資を通じて、新しい医薬品や治療法の開発に取り組んでおり、疾患の治療と予防に貢献しています。 職務内容 * Provide strong statistical leadership
Apply algorithm, data exploration skills to develop AI & data science solutions for commercial business problem. Client Details Our client is top Pharmaceutical company. They are well advance in utilising analytics tools to drive business solution. Description * Work
Join a global leader in medical devices, where youll have exposure to cutting-edge technologies and industry trends. As the AR Manager, youll contribute to the companys financial health and advance your career within a dynamic organization.
Join an innovative biopharmaceutical company dedicated to pioneering advancements in healthcare. Our client is seeking a dynamic and experienced Cardiovascular Product Manager to lead our in developing and executing marketing strategies for their new cardiovascular product
Our clients Microsoft Business Solutions team is a Microsoft Gold Partner and leader in Microsoft software implementations for medium to large organisations, providing their clients with the ability to keep up with the ever-changing digital world
Were Celonis, the global leader in Process Mining technology and one of the worlds fastest-growing SaaS firms. We believe there is a massive opportunity to unlock productivity by placing data and intelligence at the core of business