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eCTD Publishing Specialist / eCTDパブリッシングスペシャリスト(フルリモート)

Job ID R0000047743 , Japan

ポジション概要

Parexelの薬事部門では、医薬品の承認申請を支えるeCTD Publishingのスペシャリストを募集しています。

本ポジションでは、Regulatory Affairs担当者等が作成した申請資料をもとに、規制当局の要件に沿ったeCTD形式への編纂・構築を行います。

専用のPublishing Systemを使用したeCTDの作成・編纂、QC、Validation、Lifecycle Managementなど、医薬品の電子申請を支える専門的な業務をご担当いただきます。

eCTD Publishingの実務経験をお持ちの方を歓迎します。Submission全体の管理経験は必須ではなく、これまで担当者の指示のもとでeCTDの編纂・構築業務を担当されていた方も対象となります。


主な業務内容

- 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・スキルに応じて、Submission Managementや、より複雑な申請プロジェクトのPublishing業務にも携わっていただきます。


応募要件

必須要件

- 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します。


歓迎要件

- 製薬会社またはCROにおけるRegulatory Operations / Submission Management経験

- 新薬承認申請(NDA)に関するPublishing経験

- 日本の医薬品承認申請および薬事規制に関する知識

- eCTD Lifecycle Managementの経験

- 規制当局からの照会事項(Response to Questions)への対応経験

- eCTDのQC / Validation経験

- eCTDmanager、Calyx RIM、docuBridge等のPublishing / RIM Systemの使用経験


求める人物像

- eCTD Publishingの専門性をさらに高めていきたい方

- 正確性を大切にし、細かな確認作業を着実に遂行できる方

- Submissionの期限を意識しながら、関係者と協力して業務を進められる方


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