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
日本における海外バイオベンチャー企業(全体の70%)等の新薬開発プロジェクトにおいて、開発薬事戦略の策定、PMDA対応、J-NDA申請業務をリードしていただきます。
グローバルクライアントとの英語でのコミュニケーション、スピード感ある環境での自発的なプロジェクト推進が求められるポジションです。
勤務形態: 完全在宅勤務
【主要職務】
1. Regulatory Strategy(開発薬事戦略)- クライアントの開発ステージに応じた日本における薬事戦略の立案・提案
臨床開発計画と規制要件の整合性確認
リスク管理および課題解決
PMDA対面助言・相談の計画・実施(Briefing Document作成、面談同席、議事録作成)
PMDA照会事項への対応(回答書作成、クライアント調整)
PMDAとの継続的なコミュニケーション管理
J-NDA dossier作成・レビュー(CTD Module 2.5/2.7、Module 1等)
eCTD作成・提出管理
申請スケジュール管理、進捗報告
海外クライアントとのキックオフミーティング(英語)
クロスファンクショナルチーム(Medical Writing、翻訳、eCTD等)の調整
タイムライン管理、予算管理
クライアントの課題を先回りして発見・提案
定期的な進捗報告、戦略的アドバイス
【必須経験】
以下のいずれかに該当すること
1.製薬会社での薬事経験
NDA申請業務の経験
CTD作成経験(Module 2.5/2.7)
PMDA対面助言の経験(サポートレベル可)
2.製薬会社での非臨床経験
非臨床試験の報告書作成経験
CTD作成経験(非臨床パート)
申請文書作成の経験
3.製薬会社での臨床開発経験
PMDA対面助言への関与経験
CTD作成サポートまたはレビュー経験
NDA申請プロジェクトへの参画経験
4. CROでのMedical Writing経験
CTD作成経験(Module 2.5/2.7、CSR、IB)
【スキル】
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
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
Skills Required
- 3 years of regulatory experience in the pharmaceutical industry
- Experience in creating and submitting clinical trial notifications (CTN) in Japan
- Experience planning and executing PMDA consultation meetings
- Experience in NDA/BLA submission and inquiry responses
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.
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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.
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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.
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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
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.
