〈JD 〉
《業務内容》
・医療機器申請判断(各国薬事申請)
・各国薬事申請関連PJのマネジメント
・各国薬事申請書類のレビューと、薬事申請照会対応
上記業務マネジメント及び、人員のmanagement(部下あり)
※なお、薬事・臨床開発部門全体では、臨床評価、臨床試験業務も行っているため、希望に応じて薬事申請関連だけでなく、臨床評価、臨床試験業務のマネジメント経験を積むこともできる。(その他詳細は面談でお伝えします)
【求める人材】
【知識・スキル】
・医療機器法規制対応に関連したPJのマネジメントスキル
・英語力 (TOEIC700点相当以上)
・医療機器法規制の知識と薬事申請のスキル
【経験】
・医療機器の薬事申請担当経験が5年以上あること
・部門外の組織との折衝を含む部門横断的なプロジェクトマネジメント経験が、5件以上あること。(その他詳細は面談でお伝えします)
【給与】
700~1100万円
【勤務地】
東京都
【勤務時間】
求人紹介時に詳しくお伝えいたします。
【雇用・契約形態】
正社員
【待遇・福利厚生】
厚生年金基金/財形貯蓄/退職金/社員持株会制度
【休日・休暇】
祝日/有給休暇/慶弔休暇/出産・育児休暇/介護休暇/リフレッシュ休暇/創立記念日/完全週休2日制(土・日)
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