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薬事コンサルティング シニアプロジェクトリーダー / Senior Regulatory Affairs Consultant

Role overview

Qualifications

  • Practical experience in pharmaceuticals, biotechnology, medical devices, CRO, or consulting industries
  • Experience in project leadership or project management
  • Customer interaction and stakeholder management experience
  • Excellent problem-solving and communication skills
  • Business level proficiency in English and Japanese
  • Bachelor's degree or higher (science-related field preferred)

Responsibilities

  • Lead and manage regulatory consulting projects
  • Build relationships with clients and act as the main point of contact
  • Manage project planning, progress, budget, quality, and risk
  • Coordinate with internal and external stakeholders
  • Provide strategic advice and problem-solving support to clients
  • Support proposal creation, scoping, and business development
  • Guide and train junior members

Key facts

  • Remote from: Japan, Asia, East Asia, APAC
  • Freelance
  • Senior (5-10 years)
  • Regulatory Affairs Specialist
  • English

Hard skills

Other skills

  • Problem Solving
  • Quality Assurance
  • Consulting
  • Communication
  • Leadership

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.

ポジション概要

Parexel Regulatory GPLの一員として、製薬・バイオテクノロジー企業向けの薬事コンサルティングプロジェクトをリードいただきます。

クライアントの主要窓口として、プロジェクトの計画立案から実行、品質・スケジュール・予算管理までを担い、社内外の関係者と連携しながらプロジェクトを成功に導いていただきます。また、クライアントへの提案活動や新規ビジネス機会の創出にも貢献いただきます。


主な業務内容
  • 薬事コンサルティングプロジェクトのリードおよびマネジメント
  • クライアントとの関係構築および主要窓口業務
  • プロジェクト計画、進捗、予算、品質、リスク管理
  • 社内外ステークホルダーとの連携・調整
  • クライアントへの戦略的アドバイスおよび課題解決支援
  • 提案書作成、スコーピング、ビジネス開発支援
  • ジュニアメンバーへの指導・育成

応募要件
  • 製薬、バイオテクノロジー、医療機器、CRO、コンサルティング業界等での実務経験
  • プロジェクトリーダーまたはプロジェクトマネジメント経験
  • 顧客対応およびステークホルダーマネジメント経験
  • 優れた課題解決力およびコミュニケーション能力
  • ビジネスレベル以上の英語力と日本語力(直属の上司は外国在籍)
  • 学士号以上(理系学部歓迎)

歓迎要件
  • 薬事、開発、品質保証、メディカルアフェアーズ等のライフサイエンス分野での経験
  • コンサルティング業務の経験
  • 提案活動やビジネス開発への参画経験
  • 海外チームとの協働経験

このポジションの魅力
  • 国内外の製薬・バイオテクノロジー企業の重要プロジェクトをリードできる
  • クライアントの経営層や意思決定者と直接関わる機会がある
  • プロジェクトマネジメント、コンサルティング、ビジネス開発の幅広い経験を積むことができる
  • グローバル環境で専門性とリーダーシップを高められる

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Marcus Rivera

Chief Revenue Officer

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