勤務地
:東京都
雇用形態
:正社員(ハイブリッドワーク)
募集職種
:薬事リーダー
職位レベル
:Experienced Analyst, Regulatory Affairs
企業概要
当社は医療機器分野において、整形外科、外科、電気生理学、脳血管など幅広い事業領域を展開しています。革新的なヘルスケアソリューションを通じて、人々の健康に貢献することを使命としています。
ポジション概要
本ポジションでは、
整形外科領域における薬事業務のリーダー
として、事業戦略に沿った薬事戦略の立案・実行を担います。薬事マネージャーへのレポートラインとなります。
主な業務内容
- 事業戦略に基づく薬事アクションの企画・準備・実行
- 新製品導入に関する薬事戦略の構築、海外製造元との連携、薬事申請の推進
- 規制当局との交渉・連携による迅速かつ確実な承認取得
- 上市後の変更管理や供給終了に伴う薬事手続きの完遂
- 広告審査業務および社内外からの問い合わせ対応
- 部門横断的なプロジェクトへの参画
- 薬機法を中心としたコンプライアンス業務の遂行
応募資格
必須条件
- 医療機器(クラスII以上)の薬事業務経験5年以上、または同等の経験
- 英語による設計開発文書の読解力、海外関係者とのコミュニケーション能力(口頭・文書)
歓迎条件
- 規制当局との相談(開発前相談、非臨床試験プロトコル相談、臨床試験要否相談等)のリード経験
- 薬事業務全般の完遂能力およびチームメンバーのサポート経験
- 修士以上の学位(工学、理学、薬学、医学、生命科学、公衆衛生学など)
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