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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)

Role overview

Summary

This role focuses on supporting the eCTD publishing process within Parexel's Regulatory Affairs department. You will work with submission documents to ensure compliance with regulatory requirements, collaborating with various stakeholders to facilitate the electronic submission of drug applications.

Qualifications

  • Practical experience in creating, compiling, and constructing eCTD.
  • Experience using eCTD Publishing Systems.
  • Ability to perform tasks in Japanese.
  • Preferred: Experience in Regulatory Operations or Submission Management at a pharmaceutical company or CRO.
  • Preferred: Knowledge of Japanese drug approval applications and regulatory requirements.

Responsibilities

  • Create and compile eCTD submissions for drug approval applications.
  • Construct submission documents in eCTD format based on regulatory requirements.
  • Manage and verify Source Documents used in eCTD submissions.
  • Perform QC and validation of eCTD submissions.

Key facts

Hard skills

Other skills

  • Detail Oriented
  • Collaboration
  • Time Management

About the company

Parexel logo

Parexel

  • Clinical Research (CRO)
  • XLarge
  • 10,001+
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

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Job description

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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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