At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
職務概要
**求人概要**
本ポジションは、Knee(膝)、Extremity(四肢)、Biologics(生物製剤)、Trauma(外傷)事業における薬事業務全般の管理およびマーケットアクセス支援を担います。
RAマネージャーのサポートやプロジェクトの管理に加え、次世代の育成も業務の一環となります。
**主な職務内容と責任**
・日本のマーケティングチームおよびマーケットアクセスチームと連携し、Knee、Extremity、Biologics、Trauma製品の申請および償還戦略を構築
・PMDAまたはBSIへの申請文書およびSTED(新規/一部変更/認証)を作成し、承認取得までのプロセスを海外RAとのやり取りを含めてフォロー
・SAPマスター登録
・RAマネージャーおよびRAチームメンバーの支援(文書チェックなどを含む)
・変更管理プロセスの管理
・文書開示プロセスの管理
・償還申請書の作成および承認取得対応
・クラスI医療機器の届、変更届および軽微変更届の申請
・QA(品質保証)チームと連携し、新製品に関するQMS(品質マネジメントシステム)調査(FMAを含む)の準備と対応を支援
**出張要件**
国内外への出張あり(頻度は少ない)
EOE/M/F/Vet/Disability
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