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By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms
Job Purpose The Clinical Development Lead (CDL) in Japan is the single point of accountability for all clinical development activities for assigned asset(s). The CDL provides scientific and medical leadership to define and deliver Japan clinical strategy, drives innovation
Job Purpose The Clinical Scientist (CS) in Japan is responsible and accountable for clinical scientific outputs for assigned projects and studies in Japan. The CS will have accountability for approximately 2 - 4 projects (assets) at any one
About us BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse
Territory Sales Manager Would you like tobuild meaningful customer relationships while helping more people accessmobility solutions that can improve their independence and quality of life? At Permobil, we are passionateabout improving the lives of people with
United Surgical Partners International is currently seeking a Resource/Travel Administrator for the greater Houston, TX area, who can forward deploy to lead facilities on an interim basis as needed. The role is a full-time role that
Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio
JOB DESCRIPTION: Abbott Toxicology provides comprehensive drug testing solutions with innovative technology and expert insights for reliable results. JOB INFORMATION Title: Public: Business Manager Toxicology Japan. MAIN PURPOSE OF THE ROLE Individual contributor with comprehensive knowledge
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
We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes
This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in
Career CategoryRegulatory Job Description HOW MIGHT YOU DEFY IMAGINATION? Amgen is a global leader in biotechnology with a history of more than four decades of pioneering breakthroughs. Our commitment to science has led us to discover
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
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives
The near-patient Nurse will be considered the main executor of the near-patient Programs in-country medical services. Clinical: The role of the Near Patient Nurse is to provide medical case management and communication when a Prime or Prime
JOB DESCRIPTION: Regulatory Affairs Manager（RAマネージャー） モレキュラー事業部（Molecular Diagnostics） 職務概要 Regulatory Affairs Managerは、日本国内における体外診断用医薬品（IVD）および関連医療機器の薬事戦略を統括し、事業目標の達成に向けた薬事機能全体のマネジメントを担う。 本ポジションは、新製品の開発・上市に向けた薬事戦略の立案から承認取得、保険適用および保険収載戦略の策定・推進、既承認品の維持管理、規制対応、QMS適合性調査対応に至るまで、製品ライフサイクル全体にわたる薬事活動について責任を有する。 また、PMDAおよび厚生労働省との主要な窓口として、承認申請、規制戦略、保険適用・診療報酬に関する当局対応および交渉をリードし、製品価値の最大化と患者アクセスの向上を推進する。 さらに、グローバル薬事チーム、品質保証、マーケティング、サプライチェーン等の関係部門と連携し、承認戦略と保険戦略を統合した市場導入計画を推進することで、モレキュラー診断事業の持続的成長に貢献する。 加えて、薬事チームの人材育成、組織能力の強化および業務改善を通じて、高いパフォーマンスを発揮する薬事組織の構築と継続的な成長を主導する。 _ 主な職務内容（Responsibilities） 薬事戦略および事業支援 モレキュラー事業部における薬事戦略の立案・実行 新製品導入および既存製品拡販に向けた規制戦略の策定 承認取得から保険適用までを見据えた統合的な薬事戦略および市場アクセス戦略の立案 国内外の経営層および事業部門に対する薬事リスク・機会の分析および提言 薬事観点から事業計画、製品ポートフォリオおよび上市計画を支援 国内外の規制・政策変更に伴う事業影響評価および対応方針の策定 関連学会、業界団体および行政機関との関係構築を通じた事業機会の創出 モレキュラー診断およびコンパニオン診断薬領域における規制・市場アクセス動向の把握と事業戦略への反映 承認申請・保険適用および当局対応 新規製品の承認申請、認証および届出戦略の統括 PMDAおよび厚生労働省との主要窓口としての折衝 PMDA対面助言、各種相談および照会事項対応のリード 承認取得までのプロジェクトマネジメント 保険適用および保険収載戦略の立案・実行 厚生労働省、関連学会および社内関係部門と連携した保険収載・診療報酬に関する交渉の主導 承認戦略と保険戦略を統合した市場導入計画の策定 保険適用に必要となる臨床的・分析的エビデンス戦略の策定および推進 行政通知、関連法規および規制要件に関する当局協議・交渉
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
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
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our