Associate, PHAD-Japan Group

326637BR
Japan

Job Description

1. Act as PHAD-Japan representative of TRD-Japan sub team for development and submission in Japan
- Review and prepare protocols & reports for method validation, stability, any other required technical studies.
- Input Japan need to Global test procedure.
- Prepare Japanese specifications & test methods based on Global test procedure considering Japanese regulation (e.g. JP).
- Review and provide technical and scientific input to J-NDA documents such as Module3 and QOS.
- Responsible for reviewing/preparing of protocols and reports for compatibility testing required for Japanese clinical studies.
- Provide technical information required from CR, TOX and so on.
2. Act as technical experts in supporting other LFs in Japan
- As supporting MKT-J, prepare and review protocols/ reports for special stability testing and compatibility testing of marketed products.
- Provide technical information required from MKT-J or other related groups.
- Support RA CMC-J to manage change control timely by providing technical input to variation submission documents and/or response documents to HA inquiries.
3. SOPs and Development manuals
- Review and input Japan need into Global SOPs and Development manuals.
- Prepare SOPs and manuals required in Japan locally.
4. Act as QC function for clinical sample release in Japan
- Conduct release testing of clinical samples according to SOPs and the other related regulations.
- Sample Management of QC samples for releasing of clinical samples and other technical samples including Medical devices within PHAD-J.
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:
• Advanced technical or scientific university degree

Experience/Professional requirement:
• Preferably 3 years’ experience in the pharmaceutical industry
• Basic knowledge of analytical science and/or formulation development, or equivalent
• Basic knowledge of Japanese pharmaceutical regulation and quality management

English Skill:
• Fluent Japanese and Business Level English (mandatory)

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
Global Drug Development
TECHNICAL R & D GDD
Japan
東京
フルタイム
正社員
いいえ
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326637BR

Associate, PHAD-Japan Group

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