Manager, GPRM-Japan

327740BR
Sep 16, 2021
Japan

Job Description

プレシジョン・メディシンは、遺伝子等個人ごとの違いを考慮した予防や治療を行うことであり、患者さんにとってより有効性が高く副作用が少ない医療の提供を可能にします。
ノバルティスは、プレシジョン・メディシンのリーディングカンパニーの一つになることを目標として掲げており、ノバルティスのミッションである新しい発想で医療に貢献するために、革新的な医薬品等の開発とともに、その医薬品等の価値を最大限患者さんに届けるため、診断薬会社等と協働で診断薬(コンパニオン診断薬)の開発にも貢献しています。
私たち、メディカルデバイス&レギュラトリーイノベーションは、国内診断薬会社と強固な関係を築き、国内外の関連部門とともに診断薬の国内開発の戦略を立て、実行する業務を主に担っています。
また、近年急速に発展しているデジタル技術を活用し、より効率的・効果的な医薬品等の開発手法を確立することにも貢献しています。
私たちノバルティスの目標達成を目指し、患者さんに最適な医療を提供するため、一緒にチャレンジしていただける方を募集しています。ご興味ある方はぜひご応募ください。

Contribute to the overall activities in development and life cycle management of medical devices, companion diagnostics (CDx)/in vitro diagnostics (IVD) and digital assets, to developing and driving digital strategies, and to biomarker strategy and analysis.

Major Accountabilities:

Regulatory Strategy
1. Assist developing innovative and high quality regulatory strategies to facilitate regulatory processes in development and life cycle management and ensure registration with optimized labels that contribute to health and welfare of the Japanese nation, in collaboration with external partnerships.
2. Lead the team and manage external parthnerships (diagnostics, medical devices or digital technology companies) to align on regulatory strategies in order to fullfil business objectives and maximize the value of Novartis’s portfolio.
3. Represent RA for discussion of biomarker/medical devices/CDx/IVD/digital assets across line functions and industrial association activities.

Regulatory contribution for technical development and commercialization
1. Provide scientific and technical inputs for biomarker/diagnostic strategy/assessment in collaboration with Precision Medicine and Clinical Development.
2. Liaise closely with external partnerships (diagnostics, medical devices or digital technology companies) for biomarker/medical devices/CDx/IVD/digital assets.
3. Work as an SME for biomarker/medical devices/CDx/IVD/digital assets related aspects to support business including, policies, and procedures, and due diligence

HA interactions, Submissions and Approvals
1. Contribute to the regulatory activities in day-to-day operations for assigned projects.
2. Establish high quality and professional interactions with the Japanese HAs and obtain high credibility in responsible projects.

Managerial
1. Ensure adherence to regulations, guidelines and global/internal procedures as required.
2. Mentor RA associates on drug/device development.
3. Contribute synergy where appropriate across the team of projects at not only Japan but also globally.
4. Ensure timely, clear communications on issues/ risks/ regulatory with teams, Head of RA MD & RI-J and key stakeholders across the division internally. Global communication with RA MD & RI, Precision Medicine and with HAs also is appropriately conducted.
5. Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures
6. 100% timely delivery of all training requirements including compliance.

Minimum Requirements

Education:
• Degree in pharmacy, medicines, science, agriculture and/or pharmaceutical engineering discipline required
• Advanced degree (MS/PhD) or equivalent education/degree in life science/healthcare recommended

Experience/Professional requirement:
1. Train and mentor RA members concering drug/device development
2. Understand varied knowledge of Japan regulation
3. Possess extensive scientific knowledge of assigned area, and facilitate scientific interactions among experts relevant for drug/device development /maintaenance.
4. Address scientific issues across lines functions and implement action plans.
5. A variety of knowledge of biomarker discovery methodologies, assay technologies and molecular biology.
6. Define internal procedures for complying with effective regulatory requirements and enhancing quality and efficiency of the processes.
7. Effectively negotiate with cross functional teams and lead an agreement in the optimal solution, and manage internal/external negotiation on development strategies and business critical issues.
8. Excellent in effectively making presentation to clarify discussion items and raise key points to focus on in English.
9. Contribute drug development planning by integrating expertise in the regulatory, legal and business environments.
10. Possess extensive knowledge of global regulatory environment, and take appropriate actions to resolve issues identified in the projects that may negatively affect development strategy and progress

English Skill:
Fluent English as business language

Why consider Novartis?

817million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.

ノバルティスの製品は約8億人以上の患者さんに世界中で届けられています。
約10万の社員が世界中のノバルティスで働いており、その国籍は約147カ国に及びます。
ノバルティスファーマ株式会社は、スイス・バーゼル市に本拠を置く医薬品のグローバルリーディングカンパニー、ノバルティスの日本法人です。ノバルティスは、より充実したすこやかな毎日のために、これからの医薬品と医療の未来を描いています。詳細はホームページをご覧ください。https://www.novartis
Global Drug Development
REG AFFAIRS GDD
Japan
東京
フルタイム
正社員
いいえ
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327740BR

Manager, GPRM-Japan

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