JOB TITLE: 薬事スペシャリスト
DEPARTMENT: 品質保証・薬事 薬事 Cardiovascular/DIB ポートフォリオ
REPORTING TO:MANAGER
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Main Mission of Job
"Being a "bridge" to deliver "meaningful" medical device to Japanese patients"
日本の患者さんに価値のある医療機器を届ける架け橋となる
Main Responsibilities
·血管内治療機器に関連する薬事業務に従事いただきます。
·新製品のタイムリーな国内導入に向け、その製品特性、開発計画、市場およびビジネス上のニーズ、上市戦略を理解し、米国本社およびマーケティング部門と協力して、薬事承認および保険に関する申請戦略および作業計画を立案する。
·薬事申請戦略および作業計画に基づき、米国本社および国内関連部門の協力を得て必要な情報を収集し、行政当局との相談を行いながら、質の高い申請書を効率よく作成して審査当局に提出し、承認取得する。
·保険申請戦略に基づき、必要な申請書を作成し当局に提出する。区分C1またはC2申請を行う場合は、マーケティング部門、保険担当部門と協力して、国内外のエビデンスの収集、保険適用申請書の作成と提出、説明資料の作成、関連学会や行政当局との折衝を行う。
·製品の流通に際し、モデル情報の登録や帳票類の整備等、付帯する薬事関連業務を行う。
·米国本社との良好な信頼関係とコミュニケーションを維持して、必要な情報をタイムリーかつ正確に取得し、薬事行政上の必要な判断や措置を遅滞なく講じる。
·国内薬事関連法令やグローバルな薬事行政の動向、担当する製品群および関連治療についての最新の情報・知識を収集する。
·業界活動を通じ、品目の基準作成、薬事関連、保険関連などにおいて、業界側の考えを行政に提案する。
Must Haves
·学士(4年制理系大学卒)以上又はそれに相当する学位
·医療機器又は医薬品の薬事申請業務(クラスIVの医療機器の薬事申請経験があれば尚可)
·米国本社との情報交換及び技術英語読解に必要な英語能力
·論述(日本語)力
·チームワーク・コミュニケーションスキル
·プロジェクトマネジメントスキル
·一般的なPCスキル(Word, Excel, PowerPoint)
·向上心(成長意欲の高い方歓迎)
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