This is what you will do: Evidence Generation Lead manages all evidence generation program such as the Externally Sponsored Research (ESR), Medical Affairs conducting Phase 4 (P4) study Real-world evidence generation, HEOR study and Post marketing
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International SOS is the world’s leading medical and security services company with over 12,000 employees working in 1,000 locations in 90 countries. International SOS Government Services administers the TRICARE Overseas Program providing high-quality, accessible health care
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Job TitleRegulatory Affairs Manager Job Description Job Title Regulatory Affairs Manager ポジション概要 フィリップスの医療機器事業において、Hospital Patient Monitoring（HPM） および Sleep & Respiratory Care（SRC） 領域の新製品導入および既存製品の許認可維持を担うポジションです。 また、AIを活用したプロセス改善・業務変革の推進にも携わり、日本国内のみならずグローバルチームと連携しながら、Patient Safety & Quality（PSQ）全体に影響を与える変革活動をリードしていただきます。 薬事の専門性に加え、組織横断での協働やリーダーシップを発揮し、事業成長とコンプライアンスの両立に貢献いただくことを期待しています。 主な業務内容 薬事戦略・申請業務 製品ライフサイクル全体を通じたコンプライアンス確保に向け、国内薬事戦略を策定し、関連ステークホルダーとの戦略的な議論をリードする 薬事戦略、開発計画および製品に関する規制リスクを主体的に特定し、適切な代替案を提案する 国内規制要件を解釈し、海外設計元へ適切な薬事アドバイスを提供する 薬事申請資料の作成・レビューを行い、承認申請業務を推進する 既存製品の承認維持管理を行う 薬事管理・規制対応 QMS/FMR登録業務、薬事評価、販促資材レビューなどの薬事管理業務を統括する 厚生労働省、医薬品医療機器総合機構、認証機関との折衝および良好な関係構築を行う PMS（市販後監視）チームおよび品質保証チームと連携し、規制課題への対応や継続的なコンプライアンス活動を推進する プロセス改善・業務変革 AIおよびデジタル技術を活用した業務効率化・プロセス改善を推進する
Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It
Job Description SummaryThe Brand Manager is accountable for translating International and Regional Therapeutic Area strategy into locally relevant brand plans from pre-launch phase and ensuring future assets are positioned for long-term patient impact and sustainable business growth
企業概要 About AbbVie AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples
JOB SUMMARY Manages the daily functions of the department to ensure protection of property assets, employees, guests and property. Maintains logs, certifications and documents required by law and Standard Operating Procedures. Trains staff in established emergency
Job Description Summary-Planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations. May interact with investigational sites, clinical consultants, Contract Research Organizations & other vendors. Collaborates with Country medical/clinical colleagues, global clinical
Title: Quality Assurance Specialist Introduction about us: At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative
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
General Information Job Advert Title: Head, Medical Inquiry Content Japan Location: Nihonbashi, Tokyo Division: Medical Affairs Employment Class: Permanent Description 【About Astellas】 Astellas is a global life sciences company committed to turning innovative science into VALUE
embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. Driven by innovation, purpose, and a commitment to improving lives, we are expanding our portfolio of solutions to serve
【会社紹介・ビジョン】 私たちIQVIAは、ヒューマンデータサイエンスの先駆的な企業として、医療・ヘルスケアの前進に取り組む皆様をIQVIAならではの革新的なソリューションによってご支援することで、「誰もが、より健康に自分らしく生きられる社会」の実現を目指しています。世界最大規模を誇る医療・ヘルスケア関連データを基盤に、人・データ・サイエンスを融合させた見地から、未だ満たされない治療ニーズに応える、新たな医薬品や医療機器の開発と市販化、厳格化する規制やコンプライアンスへの対応、持続可能な医療システム推進の支援など、患者さんをはじめとするすべての人々のために、より良い未来へと医療・ヘルスケアを前進させていく力となることが、私たちの使命です。 世界100以上の国と地域で約9万人が活動するIQVIAの日本法人として、IQVIAジャパンでは約6,000人が一丸となり、この使命に向かって日々、力を尽くしています。 【業務内容】 • Contribute to the development of the project delivery strategy for Request for Proposals (RFPs). Participate in bid defense preparations. Lead bid defense presentations in partnership with business development for large, complex,
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
企業概要 About AbbVie AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples
企業概要 About AbbVie AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples
Company Description PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials
COA/eCOA PM&APM 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 organisation, integrity, collaboration, agility, and inclusion are at the