Parexel

End-to-end clinical trials and regulatory consulting

Ectd Publishing Specialist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeNo salary listedRemote

About the Job

Requirements

Practical experience creating, compiling, and building eCTD submissions.
Practical experience using an eCTD Publishing System or similar system.
Ability to perform work in Japanese.

Responsibilities

Create and compile eCTD submissions for pharmaceutical approval applications.
Build submission documents into eCTD format in accordance with regulatory requirements.
Review and manage source documents used in eCTD submissions.
Process and edit submission PDFs, including setting bookmarks and hyperlinks.
Perform eCTD quality control and validation.
Manage eCTD lifecycle activities.
Provide publishing support for various submissions, including new drug applications (NDAs).
Provide publishing support for responses to questions from regulatory authorities.
Coordinate with Regulatory Affairs personnel and domestic and international project members.
Track publishing-work progress in line with submission schedules.
Depending on experience and skills, participate in submission management and publishing work for more complex application projects.

Desired Qualifications

Experience in Regulatory Operations or submission management at a pharmaceutical company or contract research organization.
Publishing experience with new drug applications (NDAs).
Knowledge of Japanese pharmaceutical approval applications and regulatory requirements.
Experience with eCTD lifecycle management.
Experience handling responses to questions from regulatory authorities.
Experience with eCTD quality control or validation.
Experience using publishing or regulatory information management systems such as eCTDmanager, Calyx RIM, or docuBridge.

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

About the Company

Parexel

End-to-end clinical trials and regulatory consulting

Parexel provides end-to-end clinical development services for pharmaceutical, biotechnology, and medical device clients from Phase I to Phase IV. Its offerings include clinical trial management, regulatory consulting, and biostatistical analysis to support the design, execution, and analysis of clinical studies. The company operates as a CRO, partnering with sponsors to manage trials, ensure regulatory compliance, and generate robust data for drug development. What sets Parexel apart is its breadth of services across the trial lifecycle, emphasis on quality and reliability, and industry recognition, along with a focus on patient-centric approaches and leadership in gender partnership. The company’s goal is to help clients bring new therapies to market efficiently and safely by delivering high-quality, compliant trial outcomes and data that support regulatory submissions.

Company size: 10,001+
Company stage: Acquired
Total funding: $8.5B
Headquarters: Durham, NC
Founded: 1982

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