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Medical Writer II / メディカルライターII (在宅勤務可)

Role overview

Summary

This role focuses on creating and editing clinical documents for drug and medical device development at Parexel. You will work in a global medical writing services team, engaging with clients and collaborating with various departments to ensure high-quality documentation that meets regulatory standards.

Qualifications

  • Over 5 years of experience in the pharmaceutical industry.
  • More than 3 years of experience as a medical writer.
  • Experience in creating CTD, clinical study reports, and clinical trial protocols.
  • Ability to communicate and coordinate in both Japanese and English.
  • Preferred: Experience facilitating meetings in English

Responsibilities

  • Create and edit clinical-related documents such as clinical trial protocols, informed consent documents, and clinical study reports.
  • Develop safety reporting documents including DSUR and PBRER.
  • Collaborate with other departments like medical, statistics, and clinical operations to execute document creation projects.
  • Respond directly to client requests.

Key facts

Hard skills

Other skills

  • Collaboration
  • Communication
  • Problem Solving
  • Teamwork

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.

【職務内容】

  • 医薬品および医療機器開発における臨床関連ドキュメント(治験実施計画書、同意説明文書、治験総括報告書、CTD 等)、安全性報告文書(DSUR、PBRER 等)、ならびに論文および抄録の作成、編集。
  • クライアントの要望に直接応えながら、他部門(メディカル、統計、臨床オペレーション、薬事など)と連携し、文書作成プロジェクトを遂行する。

【必要業務経験】

  • 医薬品業界の経験が5年以上、メディカルライターとしての経験が3 年以上
  • メディカルライターとしてCTD、治験総括報告書、および治験実施計画書作などの文書作成の経験者(論文の作成経験があればなおよい)。
  • 日本語・英語による口頭および文書でのコミュニケーションと調整能力(英語での会議ファシリテーション経験あれば尚可)

【求める人物像】

  • クライアントに焦点をあてた仕事への取り組み姿勢。
  • 高いライティング能力、コミュニケーション能力および問題解決能力を有し、困難な状況でも柔軟かつ真摯に取り組める方。
  • チームワークを重視し、積極的に周囲をサポートし、チームの成長のために自身の知識・経験を周囲共有できる方。

【ポジションの魅力】

所属部門は「メディカルライティングサービシーズ」というグローバル部門のアジアパシフィックリージョンに所属し、日本国内の案件のみならず、諸外国のメディカルライターやグローバル企業のクライアントとも直接コミュニケーションをとる機会が多く、国際的な環境の中でメディカルライターとして成長することができます。

過去に作成経験のない文書や特定の知識(各国の要件に関する知識等)を有する文書を作成する場合は、SME(Subject Matter Expert)と呼ばれる当該文書について深い見識を持つメディカルライターやその文書の経験が豊富なメディカルライターが、メンターとしてサポートする制度が整っています。また、自身がリージョンSME となり、他リージョンのSME とともに専門知識をさらに磨く機会もあり、メディカルライターとしての専門性をさらに高めることが可能です。

社内の業務手順書(SOP)や各種文書のテンプレートは、業界の動向に基づき最新の情報に随時更新され、情報シェアのためのトレーニングも頻繁に実施されていることから、ライティング業務に集中しながらもメディカルライターに必要な最新の知識を身に着けることが可能です。


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