社名
社名非公開
職種
臨床開発、CRA、CRC
業務内容
研究開発に投資をしておりパイプラインが豊富
ワークライフバランスの取れる制度が充実している
求められる経験
Quality Specialistとして国内外の関連する規制に精通し、開発関連部門と連携し、PMDA適合性調査の対応や、Audit findingに対するCAPA対応、プロセス管理など、臨床試験のQuality全般のマネジメントに関わる業務を担当いただきます。
海外の同僚と議論できる英語力、プレゼンテーションスキル、様々な部署との調整など円滑なコミュニケーションスキル、ロジカルシンキングや問題解決力、そして新しいことを学ぶ意欲を持っていることなどが、必要な資質です。
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r&d, quality management unit, country clinical quality manager (ccqm)：製薬企業.
- posted 17 december 2024
- closes 6 january 2026
experience
Quality Specialistとして国内外の関連する規制に精通し、開発関連部門と連携し、PMDA適合性調査の対応や、Audit findingに対するCAPA対応、プロセス管理など、臨床試験のQ
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