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 Operations Sr. Project Manager, 規制提出プロジェクトマネージャー
Job not on LinkedIn
🔥 0 minutes ago
🗣️🇯🇵 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
• 規制提出プロジェクトの計画策定、タイムライン管理、および進捗管理 • クロスファンクショナルチームとの連携による提出戦略・責任分担の明確化 • 提出ドキュメントの品質・整合性確保および課題解決 • 規制出版部門および外部ベンダーとの連携による提出成果物の管理と進行調整 • 提出内容のレビューおよび各国規制ガイドラインへの準拠確認 • PMDA相談、臨床試験通知、変更申請、軽微変更届、承認申請の提出支援 • 提出テンプレートおよび標準プロセスの維持・改善 • 規制提出における標準化・一貫性の推進 • EDMS(電子文書管理システム)内の文書およびメタデータ管理
🎯 Requirements
• 学士号以上 • 製薬業界における6年以上の関連経験(Regulatory Affairs / Submission / Operations) • 規制提出プロセスおよびeCTDガイドラインに関する深い知識 • プロジェクトマネジメントおよびスケジュール管理スキル • Veeva Vault RIM、docuBridge等の提出関連システムの使用経験 • eCTD作成および検証プロセスの実務経験 • MS OfficeおよびAdobe Acrobatの高い操作スキル • 日本語:ネイティブレベル • 英語:ビジネスレベル(読み書き+会議対応)
🏖️ Benefits
• フルリモート • 健康保険 • 年次有給休暇
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