Parexel

開発薬事シニアコンサルタント(派遣モデル)

Parexel  •  Tokyo, JP (Remote)  •  5 months ago
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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

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)
Parexel

About Parexel

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 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.

Industry
Chemicals & Materials
Company Size
10,000+ employees
Headquarters
Raleigh, North Carolina
Year Founded
Unknown
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