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

Posted 7 Days Ago
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2 Locations
In-Office or Remote
Senior level
Pharmaceutical
The Role
Manages pharmaceutical regulatory projects from initiation through completion, coordinating clients, consultants, timelines, budgets, resources, PMDA consultations, vendors, training, meetings, and performance improvements. Acts as the client liaison, develops strategic plans, prepares budget reports, and ensures compliance with SOPs and project management plans. The role supports new drug development and offers opportunities to transition into regulatory consulting or broader project leadership.
Summary Generated by Built In

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
レポート先
海外の上司へレポート(ヨーロッパ)

Skills Required

  • Problem-solving ability
  • Project leadership and project management knowledge
  • Excellent interpersonal and cross-cultural communication skills
  • Client-focused approach
  • Teamwork and collaboration skills
  • English communication skills
  • Project management experience
  • Pharmaceutical industry experience

Parexel Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.

  • Healthcare Strength Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
  • Retirement Support Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
  • Leave & Time Off Breadth Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.

Parexel Insights

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The Company
HQ: Raleigh, NC
20,524 Employees

What We Do

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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