Parexel
10,000+ employees
Founded 1983
💼 Consulting
🏥 Healthcare
📦 Logistics
💰 Venture Round on 1990-01
Consulting • Healthcare • Logistics
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.
eCTD Publishing Specialist, eCTDパブリッシングスペシャリスト
🔥 1 minute ago
🗣️🇯🇵 Japanese Required
Where this job comes from
Posted on Parexel's careers page, not through a job board
First seen by Remote Rocketship 1 minute ago
Parexel
10,000+ employees
Founded 1983
💼 Consulting
🏥 Healthcare
📦 Logistics
💰 Venture Round on 1990-01
Consulting • Healthcare • Logistics
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
• 医薬品の承認申請等におけるeCTDの作成・編纂 • 規制要件に基づいた申請文書のeCTD形式への構築 • eCTDに使用するSource Documentの確認・管理 • 申請用PDFの加工・編集、Bookmark、Hyperlink等の設定 • eCTDのQCおよびValidation • eCTD Lifecycle Management • 新薬承認申請（NDA）を含む各種SubmissionのPublishing Support • 規制当局からの照会事項（Response to Questions）に対するPublishing Support • Regulatory Affairs担当者や国内外のプロジェクトメンバーとの連携 • Submissionスケジュールに沿ったPublishing業務の進捗管理 • 経験・スキルに応じたSubmission Managementや、より複雑な申請プロジェクトのPublishing業務
🎯 Requirements
• eCTDの作成・編纂・構築に関する実務経験 • eCTD Publishing System等を使用した実務経験 • 日本語で業務を遂行できること • 製薬会社、CROだけでなく、eCTD Publishingサービスを提供するベンダー等での経験も歓迎 • 製薬会社またはCROにおけるRegulatory Operations / Submission Management経験（歓迎） • 新薬承認申請（NDA）に関するPublishing経験（歓迎） • 日本の医薬品承認申請および薬事規制に関する知識（歓迎） • eCTD Lifecycle Managementの経験（歓迎） • 規制当局からの照会事項（Response to Questions）への対応経験（歓迎） • eCTDのQC / Validation経験（歓迎） • eCTDmanager、Calyx RIM、docuBridge等のPublishing / RIM Systemの使用経験（歓迎）
🏖️ Benefits
• フルリモート • Full time employment
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