Tokyo Michael Page
グローバルチームと連携し、日本の薬事戦略をリード
柔軟な働き方・多様性を尊重する企業文化

About Our Client

希少疾患領域に強みを持ち、革新的な医薬品の開発・提供を行うグローバルバイオファーマ企業。患者中心の価値観を大切にし、科学と倫理を融合させた企業文化が根付いています。

Job Description

日本における薬事戦略の立案・実行(製品・プロジェクト単位)
厚生労働省との折衝・会議の計画と実施(グローバル戦略との整合)
臨床試験届、製造販売承認申請、希少疾病指定申請などの薬事申請業務
社内関連部門との連携による薬事文書の作成・スケジュール管理
Japan Project Teamの薬事リードとしてSubmissionチームを牽引
規制要件・業界動向の情報収集と社内への共有

The Successful Applicant

製品承認経験を含む薬事業務経験(JRAリーダーとしての実績)
理系学士号(薬学、医学、獣医学、農学、医療経済など)※修士歓迎
Microsoft 365(特にPowerPoint)の高度な操作スキル
Veevaなどの薬事文書管理システムの使用経験

What's On Offer

フレックスタイム制度・在宅勤務制度あり
ダイバーシティ&インクルージョンを重視した職場環境
グローバルなキャリアパスと成長機会
社員の健康とウェルビーイングを支援する制度が充実

Contact: Kao Toyama

Quote job ref: JN
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