JOB DESCRIPTION: MAIN PURPOSE アボットメディカルジャパンが取り扱う循環器領域の医療機器（主にクラスⅣの高度管理医療機器）において、薬事担当者として高い専門性と自立性をもって薬事業務を主導し、製品の承認取得およびライフサイクル全体にわたる規制対応を推進します。 シニア～プリンシパルレベルの 個人貢献型プロフェッショナル として、複雑性の高い案件や関係部門・規制当局との調整をリードする役割を担います。 MAIN RESPONSIBILITIES - 当社製品における承認申請、変更申請、定期報告等の作成・提出の主担当 - 規制当局（PMDA等）との照会対応、折衝を通じた承認取得の推進 - 製品ライフサイクル全体（開発～上市後）における薬事対応のリード - 社内関係部署（研究開発、品質、製造、マーケティング等）との横断的な調整および助言 - 規制要件・ガイドラインの解釈を踏まえた薬事方針の検討・提案 - グローバル薬事チームとの連携、情報共有、英語での会議・文書対応 （プリンシパル相当の場合） - 組織内における薬事の専門的相談窓口 - 若手薬事メンバーへの助言・支援 QUALIFICATIONS 必須要件 - 理系学士卒以上（修士・博士歓迎） - 医療機器薬事の実務経験：5年以上 - クラスⅢ／Ⅳ 医療機器に関する薬事経験
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON)
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON)
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON)
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON)
Job Description: Your responsibilities: Responsible for related academic communication which includes establishing and keeping the faithful relation with opinion leaders, academic cooperation with outside experts in the specialty area, i.e., urology, uro-oncology, and gastroenterology, sharing and
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON)
Job Description SummaryThe Japan Program Clinical Head (JPCH) is responsible for clinical program activities for approval and post approval commitment for Re-examination in Japan. The JPCH is responsible for one or more clinical programs across indications,
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON)
About Convatec Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON)