業務内容
◇職務内容(About the position)
製品開発責任者は、SHIONOGIが掲げる"Healthcare as a Service (HaaS)"と早期診断/早期治療 ("Test to Treat") の実現のために、SHIONOGIがグローバルに展開する医薬品開発及びヘルスケアサービスに必要な様々なモダリティを用いた診断薬、診断・医療機器や診断・医療ツールの開発と製品化を担当し上市を達成する。そのために、社内の関係部署、社外のパートナー企業やアカデミア/KOLと緊密に連携してニーズに合致した製品特性の実装化を進め、SHIONOGIが目指す最もよいヘルスケアソリューションのグローバル展開とヘルスケアの未来創出に貢献する。診断薬・医療機器の製品責任者は、製品開発プロジェクトにおいて以下の責任を担う。
・顧客要求、技術要件、規制要件を考慮して製品仕様を策定する
・設計開発責任者と連携して製品開発をリードする
・上市後においてマーケティング部門と連携し市販後の製品改良や、市場/ユーザーからのフィードバックを基にした設計変更を主導し、ライフサイクルマネジメントを推進する
・製品のライフサイクル全体(開発、上市、市販後管理、改良、販売中止、事業承継)にわたり、川上(開発)から川下(市販後)への情報・課題の双方向連携を実現し、関係部門とのクロスファンクショナルな調整を通じて、製品価値の最大化と持続的な改善に貢献する
The Product Development Lead is responsible for driving the development and commercialization of diagnostic reagents, diagnostic and medical devices, and diagnostic and medical tools using various modalities necessary for SHIONOGI’s global pharmaceutical development and healthcare services, in order to realize SHIONOGI’s vision of "Healthcare as a Service (HaaS)" and "Test to Treat" for early diagnosis and early treatment. To achieve this, the lead will work closely with internal departments, external partner companies, and academia/KOLs to implement product characteristics that meet market needs, contributing to the global deployment of SHIONOGI’s best healthcare solutions and the creation of the future of healthcare.
The Product Owner for diagnostic reagents and medical devices will assume the following responsibilities within product development projects:
Define product specifications considering customer requirements, technical requirements, and regulatory requirements.
Lead product development in collaboration with the design and development lead.
After launch, work with the marketing department to drive post-market product improvements and design changes based on market/user feedback, promoting lifecycle management.
Throughout the entire product lifecycle (development, launch, post-market management, improvement, discontinuation, and business succession), ensure bidirectional communication of information and issues from upstream (development) to downstream (post-market), and contribute to maximizing product value and continuous improvement through cross-functional coordination with relevant departments.