薬事(薬事申請)の課長(マネージャー)の転職・求人情報

HEOR Manager Your impact begins hereAs HEOR Manager, you will build the economic and clinical evidence that helps new treatments reach people in Japan. You will prepare HTA submissions, negotiate with MHLW and C2H, and shape HEOR and real-world evidence plans for your assigned products and therapeutic areas. As one of two HEOR colleagues in Market Access, your work influences access at launch and the value our products deliver over time for people living with serious chronic diseases.What you’ll bringYou know how to turn evidence into agreement with decision-makers, and you are at ease working across functions and borders.A bachelor’s degree or higher, ideally in health economics, outcomes research, epidemiology, statistics, life sciences or a related field.Experience in the pharmaceutical industry.Experience engaging and negotiating with authorities, such as government and payer-related bodies.Experience collaborating across functions and managing projects, including working with global or regional colleagues.Japanese at native or N1 level, and English at business level or above.Strong communication, influencing and problem-solving skills, with the integrity and professionalism that trusted dialogue with authorities requires.Useful, but not essentialExperience in HEOR or HTA, including HTA submissions.Experience with health economic or budget-impact modelling, or with real-world evidence.A master’s degree or PhD in health economics, outcomes research or a related field.Experience working with industry associations or leading cross-functional initiatives from planning to delivery.What you’ll doYou will lead HEOR work from evidence planning through to negotiation, so that the value of our treatments is clear to those who decide on access.Lead

医療機器メーカー等のクライアント企業から依頼を受け、薬事申請業務全般のコンサルティング・支援業務を行うポジションです。新製品の市場投入から既存製品の維持管理まで、クライアントのニーズに応じて幅広く対応します。PMDAへの各種申請書類作成支援、照会事項対応のアドバイス、QMS省令への対応支援など、医療機器薬事のプロフェッショナルとしてクライアントの薬事業務をサポートしていただきます。将来的には複数のクライアントを担当し、より高度な薬事コンサルティングに携わることを期待しています。【具体的な業務内容】・クライアント企業の医療機器薬事申請業務（届出、認証申請、承認申請）の支援・PMDA事前相談の準備支援および照会事項への対応アドバイス・STED（技術文書概要）の作成支援および添付文書の作成・レビュー・海外製造元からのデータ収集・翻訳調整のサポート・クライアントのプロモーション資材の薬事チェック・アドバイス・変更管理および定期更新手続きの支援【求める人物像】・感謝と敬意をもって周囲と接することができる方・高いコミュニケーション能力をお持ちの方・自主性をもって行動できる方・多様性を尊重し、柔軟に受け入れられる方