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(Senior) Project Manager / 薬事申請プロジェクトマネージャー

Role overview

Qualifications

  • Problem-solving skills
  • Project leadership and management knowledge
  • Excellent interpersonal and cross-cultural communication skills
  • Client-focused approach

Responsibilities

  • Act as the client's point of contact and understand project scope and requirements.
  • Manage timelines, costs, and personnel from project start to completion.
  • Facilitate client meetings and develop strategic plans regarding regulatory services.
  • Prepare project meetings and liaise with vendors as needed.

Key facts

Hard skills

Other skills

  • Leadership
  • Communication
  • Problem Solving
  • Intercultural Communication
  • Teamwork

About the company

Parexel logo

Parexel

Contract Research Organizations (CRO)

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.

Company details

Company typeXLarge
IndustryContract Research Organizations (CRO)
Company size10001

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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:パレクセルコンサルティング(薬事部門)は、主に海外のバイオテックカンパニーをクライアントとして、新薬開発計画の戦略プランからPMDA相談、申請、承認取得までのサービスを提供しております。そこで、プロジェクトリーダーは、プロジェクトの形態やクライアントニーズに応じて、プロジェクトの開始から完了までの全期間にわたり、コンサルタントとコミュニケーションをとり、プロジェクトの進捗を管理します。詳細は以下をご参照ください。
  • クライアントの窓口となり、業務依頼(Statement of Work、予算、要求、期待値)を確認し、プロジェクトの範囲と要件を理解。
  • 必要に応じ、クライアントとの会議を設定、ファシリテートし、薬事サービスに関するニーズ、問題点につき話し合い、戦略的計画を立てる。
  • プロジェクトチームの発足からプロジェクト終了までの全てのプロセスにおいて、タイムライン、コスト、人員を管理。
  • コンサルタントからの情報を収集し、スケジュール、リソースの変更、管理。
  • SOPやプロジェクトマネジメントプランなどに従って、必要なシステム、ツールのセットアップ、タイムコードの設定。
  • PMDA相談の調整、出席
  • トレーニングの設定および管理。
  • プロジェクトミーティングのための準備。
  • 通訳などのベンダーとの連絡、必要なファイルを提供。
  • プロジェクト効率、パフォーマンスの改善。
  • 予算管理レポート作成、分析、レビュー。
  • その他、会社の指示命令事項
ポジションの魅力
  • 新薬開発までの一連の流れ(各国の規制要件比較、PMDA相談、KOL意見徴収、CTD作成などのサポート)を体感できる。
  • 将来、薬事コンサルタントや全フィールドのプロジェクトリーダーへキャリア チェンジできる。
  • 英語力が活かせる。
求める経験、スキル
  • 問題解決能力
  • プロジェクトリーダーシップと管理知識
  • 優れた対人およびクロスカルチャーコミュニケーションスキル
  • クライアント重視のアプローチ
  • チームワークとコラボレーションスキル
  • 英語でのコミュニケーション
  • プロジェクトマネジメントの経験
  • 医薬品業界での経験があれば、尚可
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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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