Parexel
10,000+ employees
Founded 1983
⚕️ Healthcare Insurance
🧬 Biotechnology
💊 Pharmaceuticals
💰 Venture Round on 1990-01
Healthcare Insurance • Biotechnology • Pharmaceuticals
Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.
Regulatory Affairs Clinical Consultant – シニア
🕒 March 12
🗣️🇯🇵 Japanese Required
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Parexel
10,000+ employees
Founded 1983
⚕️ Healthcare Insurance
🧬 Biotechnology
💊 Pharmaceuticals
💰 Venture Round on 1990-01
Healthcare Insurance • Biotechnology • Pharmaceuticals
Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.
📋 Description
• 日本における開発薬事戦略の策定 • PMDA相談面談の管理 • 臨床開発に関連する薬事申請業務の主導
🎯 Requirements
• 製薬業界における開発薬事経験3年以上 • CTDM(2.5&2.7/2.4&2.6)の作成・提出経験 • 日本における治験届(CTN)の作成・提出経験 • PMDA相談面談(対面助言等)の計画・実施経験(サポートでも可) • 承認申請(NDA)および照会事項対応の経験 • メディカルライターとして上記の業務に携わった経験
🏖️ Benefits
• 完全在宅勤務 • 安定したインターネット環境を備えた在宅勤務環境
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