Manager, TRD Project management

Job Purpose

Contribute to development, submission, approval and launch of Novartis products in Japan from technical development viewpoints.

Represent TRD in JPT and represent TRD-J in global TRD sub team.

Interact with TM-J for evaluation of early phase projects and for ESS.

Interact with PharmOps-J and/or Marketing-J for appropriate technical development and successful launch in Japan.

Major Accountabilities

Represent TRD-J in the TRD sub team for assigned projects Represent TRD in the JPT for assigned projects Assure progress (science, time, cost) on assigned project in TRD-J, share the information with global TRD, and input Japan specifics to TDP and PDC for assigned projects Lead TRD-J sub team for assigned projects Plan and monitor TRD-J contribution to project (discuss & coordinate activities within Japanese line functions). Elaborate/ monitor TRD-J budget Interact with TM-Japan for projects in assigned therapic area Evaluate early phase projects to propose Japanese input for global sPoC proposal Support preparation of ESS, e.g. drug supply, compatibility, etc. Interact with PharmOps-J and Marketing-J for appropriate technical development and successful launch in Japan for assigned projects Evaluate projects at any global stage before JPT is formed (GPT exists but JPT is not formed) for projects in assigned therapic area Support Due Diligence in Japan on demand base Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures 100% timely delivery of all training requirements including compliance

Education:

• Technical or scientific university degree

Experience/Professional requirement:       

• Experience of CMC roles in the pharmaceutical industry
• Solid knowledge of regulatory environment
• Experience of working in a global environment

English Skill:

• Fluent: oral and written

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:   https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Accessibility and Accommodation:

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.china@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network. You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account.

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.co.jp

Japan

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to midcareer.japan@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

ノバルティスは障害を持つ個人と協力し、合理的配慮を提供することをお約束します。

健康状態や障害を理由に採用プロセスのいかなる部分においても、あるいは職務の必須事項を果たすために合理的配慮が必要な場合は midcareer-r.japan@novartis.com宛てに電子メールをお送りください。その際ご依頼内容、ご連絡先、求人票の番号を明記してください。