[DJ] 非臨床開発研究部 [DSRD] リサーチアンドディベロップメントサイエンティスト（専門管理職・一般社員）/Research and Development Scientist （Research & Development Scientist / DSRD-Tokyo）
- Japan - Tokyo
１．主な職務における成果責任/ Description of Primary Role & Responsibility
Summary
■ 日本における医薬品の承認申請業務（非臨床3パート：薬理、動態、毒性）
■ 薬事関連資料（IB, CTDなど）の作成及び当局からの照会事項、対面相談の対応等
■ Global部門の開発戦略に基づいた、日本での非臨床研究開発戦略の立案と実行
■ 非臨床研究開発の専門分野における日本における情報発信
■ 日本のサイエンスの現状を調査・情報収集し、Global非臨床研究開発部門にOpen Innovationとして紹介、共同研究の機会の構築
Responsibilities
■ 日本における医薬品の承認申請業務（非臨床3パート：薬理、動態、毒性）
- 日本の開発プロジェクトチームに非臨床(3パート)の専門家として参画し、プロジェクトにおける専門的科学知識やノウハウを提供
- 開発ターゲットにおける科学的知識、競合や規制ガイドラインの情報を把握
- プロジェクトの進捗状況、可能性のある障害等を把握、チームに発信する
- Globalで実施されている非臨床試験の進捗をモニターし、チームに情報を提供する
- 非臨床関連の規制ガイドラインに関する専門家としてファイザーDJ（研究開発部門）およびファイザーJapanに対して、貢献する
- プロジェクトに関わる規制当局（PMDA等）との会議にDSRDの代表として参加する
■ 薬事関連資料（IB, CTDなど）の作成及び当局からの照会事項、対面相談の対応等
- 非臨床に関連する規制文書（PMDA相談、CTPN,CTDなど）を作成しGlobal担当者と協力してPMDAの質問に対応する
- グローバル規制文書に、日本での規制を適応させ包括的な非臨床評価を行う
- 文書のレビュー等を含めて、非臨床分野の規制文書の作成をタイムラインに合わせて実施する
- Globalの担当者と協力して、日本の基準に基づいた規制文書のコンテンツ、フォーマットに責任を持つ
■ Global部門の開発戦略に基づいた、日本での非臨床研究開発戦略の立案と実行
- 日本での非臨床研究開発戦略を立案・実行
- 日本でのリスクマネジメント戦略を立案、実行
■ 非臨床研究開発の専門分野における日本における情報発信
- 臨床試験開始をサポートするための非臨床試験の実施の必要性について、インターナル・エクスターナルインフルエンス戦略を立案・実行する
■ 日本のサイエンスの現状を調査・情報収集し、Global非臨床研究開発部門にOpen Innovationとして紹介、共同研究の機会の構築
２．応募資格/ Qualifications
【資格・能力要件/ Desired Behavioral and Technical Skills】
■ 医学・薬学・生物学系の修士課程以上の大学院修了者／獣医師
■ International薬事ガイドラインおよび安全性評価に関する知識
■ 医薬品の薬事関連文書作成スキル
■ 英語での文書作成およびコミュニケーションスキル （業務を遂行する上で必要なレベル）
■ New modalities分野の科学知識
■ 良好なコミュニケーション能力
【職務経験】
■ マトリックスおよび複数ラインでの協業ができること
■ 医薬品研究開発の実務経験者
■ 動物実験の実務経験者（毒性試験等）
■Globalでの薬事申請業務経験者
【勤務地】 東京本社
【募集人員】1名 / No. of posting: 1
Office Worker (日本 Japan)
Work Location Assignment: Hybrid
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Regulatory AffairsBreakthroughs that change patients’ lives
Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.
Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:
“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.
“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.
“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.
Our Values
To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.
Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.
Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.
Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.
Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.
Pfizer Research & Development
Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.
With an unwavering commitment to innovation, we use a multidisciplinary approach that blends scientific expertise, cutting-edge technologies, and strategic collaborations, igniting a powerful engine that propels groundbreaking discoveries into life-saving treatments for patients in need.
Through our relentless pursuit of progress, we envision a future where cutting-edge medicines pave the way to healthier, happier lives worldwide.
Benefits at Pfizer
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.
Our Competitive Benefits Programs help our colleagues by:
- Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
- Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
- Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.
- And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
For U.S. based jobs, view an overview of Pfizer’s U.S. benefits program (opens in a new window)