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Jobs at Parexel

Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.

開発薬事シニアコンサルタント(派遣モデル)

Job ID R0000037652 , Japan

ポジション概要

本ポジションは、ParexelのFSPモデルに基づき、特定の製薬企業様専任として配属されます。製薬企業様の日本薬事チームの一員として、日本における開発薬事戦略の策定、PMDA相談面談の管理、および臨床開発に関連する薬事申請業務を主導していただきます。

勤務形態:基本的に在宅勤務(必要に応じて製薬企業様のオフィスに出勤)

主要職務

  • 薬事戦略およびプロジェクト管理
  • PMDA対応
  • 臨床開発関連の薬事申請
  • 承認申請関連業務 等

必須要件

経験:

  • 製薬業界における開発薬事経験3年以上
  • 日本における治験届(CTN)の作成・提出経験
  • PMDA相談面談(対面助言等)の計画・実施経験
  • 承認申請(NDA/BLA)および照会事項対応の経験があれば尚可

知識:

  • 日本の薬事法規(医薬品医療機器等法、GCP省令等)に関する深い知識
  • ICHガイドライン(E6、E8、E9、M4等)に関する知識
  • 日本の薬事システム(FDシステム、jRCT、PMDA-RS等)への精通

スキル:

  • 優れた日本語および英語の口頭・文書コミュニケーションスキル(ビジネスレベル以上)
  • 複雑な薬事文書の作成能力
  • Veeva Vault等のeDMSシステムに精通していることが望ましい
  • 細部への注意力、自発性、マルチタスク能力
  • 在宅勤務環境での自己管理能力および高いコミュニケーション能力
  • 問題解決能力および戦略的思考力

その他:

  • 安定したインターネット環境を備えた在宅勤務環境
  • 必要に応じた出張が可能なこと(クライアントオフィス、PMDA等)

#LI-REMOTE

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RECRUITMENT FRAUD ALERT

It has been brought to our attention that there has been fraudulent activity by scammers attempting to represent themselves as Parexel employees or recruiters. These individuals are attempting to reach potential job seekers through online chat interviews and sending false offer letters, representing Parexel without our consent. If you’re concerned that you’ve been contacted by an unauthorized Parexel recruiter or employee, please notify Jobs@Parexel.com. You may also report suspicious fraudulent activity to your local law enforcement agency or the FBI. Thank you.

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