Osaka ICONクリニカルリサーチ(同)
■PMDA厚生労働省等の規制当局との面談・折衝■薬事分析(Regulatory Assessment)実施■Global PRA(欧州・アジア各国)及びクライアントとの協働■Global PRAへの日本に於ける薬事要件のインプットと協議、協働

■社内他部門との連携と薬事観点のアドバイス提供

■薬事関連資料(各種面談資料、治験届、CTD 等)の作成・作成リード

■新薬申請から承認取得までの各種対応のリード

■新規クライアントに対する、薬事戦略(Regulatory Strategy)の提案やプレゼンテーション

■チームメンバーのスキルアップへ向けたメンター業務

  • Osaka IQVIA Full time

    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 head or ...


  • Osaka Takeda Full time

    Description · "Better Health for People, Brighter Future for the World" is the purpose of a company. We aim to create a diverse and inclusive organization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive ...

  • Clinical Team Lead

    2週間前


    Osaka TOK Fortrea Japan kk (Co., Ltd. in English) Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and techn ...


  • Osaka Takeda Full time

    Description · Please note this job requiresbusiness level Japanese in speaking, writing, and reading. · "Better Health for People, Brighter Future for the World" is the purpose of a company.We aim to create a diverse and inclusiveorganization where people can thrive, grow and ...


  • Osaka Takeda Full time

    Description · Please note this job requiresbusiness level Japanese in speaking, writing, and reading. · "Better Health for People, Brighter Future for the World" is the purpose of a company.We aim to create a diverse and inclusiveorganization where people can thrive, grow and r ...


  • Osaka Universal Beijing Resort IT

    Manager, Infrastructure Operations (IOps) and Parkwide Technical Infrastructure (PTI) · Summary · Responsible for daily leadership of the Universal Studios Japan resources that design Universal Parks and Resorts data centers and other critical environments according to Universa ...


  • Osaka Regal Rexnord Full time

    Position Summary · Reporting to the Sales Director-Southeast Asia. Account Manager-Japan is responsible for ownership of an established Japan account base and new account development in the Industrial Power Train OEM, and End User markets. The primary role of this position is to ...


  • Hyogo Lilly Full time

    We're looking for people who are determined to make life better for people around the world. · Local device stewardship is expected to be the master of devices and accountable for the related information/communication demonstrating following duties locally to meet business needs ...


  • Hyogo Lilly フルタイム

    We're looking for people who are determined to make life better for people around the world. · 担当疾患領域(糖尿病/循環器疾患)の専門家として病態や治療薬に関する深い知識を背景に、領域専門医等からの医学・科学的な疑問点やニーズに対応することにより、患者さんの病状改善やQOL向上に貢献する。また領域専門医等との議論を通じて得た意見やニーズを社内関係部署に還元し、製品価値の最大化に貢献する。 · 主な職責/Primary responsibilities · 領 ...


  • Kobe Lilly フルタイム

    We're looking for people who are determined to make life better for people around the world. · 【安全】 · 労働災害ゼロを実現するために、安全衛生活動に常に注意を払い、安全文化の理解と構築に積極的に取り組む · 安全衛生改善のための助言や行動を自ら行う · 【技術/品質】 · 関連部門と連携し、顧客の期待や規制要件を満足する検査・一次包装・二次包装プロセスを設計する。また、それを検証する · 仕様書、手順書、バリデーション計画書/報告書など、技術 ...


  • Hyogo Lilly フルタイム

    We're looking for people who are determined to make life better for people around the world. · 背景と職務内容 · 本担当者には大きく2つの業務スコープが期待されています。 · まず、本担当者には実際にブランドチームとの窓口担当者として、最適な製作方法やプロセスの提案、再活用可能な国内外の素材の特定、実際の改訂作業、納品等を行い、期日内・予算内での製作を完遂させます。 · Lillyでは、昨今の様々な環境変化に対応するべくプロモーション資材のコンテンツ(例:グ ...

  • Director of Revenue

    2週間前


    Yawata Hyatt Corporation Full time

    Director of Revenue · Park Hyatt Park Hyatt Kyoto Higashiyama JP - Kansai - KyotoRevenueDirectorFull-timeReq ID: KYO000658Local Summary · Job Description · About Park Hyatt · Finding luxury in every detail, Park Hyatt hotels provide discerning, affluent business and leisur ...


  • Yawata Hyatt Corporation Full time

    Director of Sales & Marketing - Park Hyatt Kyoto · Park Hyatt Park Hyatt Kyoto Higashiyama JP - Kansai - KyotoSalesDirectorFull-timeReq ID: KYO000638Local Summary · About Park Hyatt Kyoto · Park Hyatt Kyoto, a luxury hillside guesthouse in the heart of Higashiyama, combines ...


  • Kobe Lilly Full time

    We're looking for people who are determined to make life better for people around the world. · Primary responsibility for data management activities within the site. · Main Responsibilities · Own site actions associated with the enterprise data management and integrity initiative ...


  • Hyogo Lilly Full time

    We're looking for people who are determined to make life better for people around the world. · 職務内容/Job Responsibilities · 医薬品ライフサイクルを通して、必要な実臨床下(リアルワールド)データの取得、構築、利活用の包括的な戦略立案と実行をリードし、エビデンス創出力を革新的に向上させる役割を担います · 主な職務 · 領域および組織横断的なRWD取得あるいは構築の包括的な戦略、計画の立案と実行 · 国内外部環境革新を活用したRWD利 ...