346425BR
Aug 04, 2022
Japan

Job Description

9.4 billion spend on Research and Development. That commitment resulted in 24 major regulatory approvals in 2019 in the US, EU, Japan and China.

Major Accountabilities:
-Contributes, with appropriate oversight, to all aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team.

-Contributes to all operational/clinical trial deliverables that are in scope of the specific JD, according to timelines, budget, operational procedures, quality /compliance & performance standards.
-May contribute to development of specific sections of the protocol & related documents;
-Development of study tools, guidelines & training materials;
-Implementing issue resolution plans; -May/may not be acting as point of contact for all site-related issues & procedural questions;
-Assist with program level activities (e.g., tracking of program
-Managing interactions with relevant line functions including data management, drug supply management, clinical development and/or Novartis Country Pharma Organizations;
-Managing interactions with relevant line functions including data management, drug supply management, clinical development & Novartis Country Pharma Organizations;
-Ensuring proper handling of all appropriate study start-up, conduct & close out activities including but not limited to site close out, final drug accountability & audit readiness of Trial Master File documentation (if in scope of the specific JD).
-Responsible for implementation of best practices & standards including sharing lessons learned. -Frequent internal company & external contacts. May represent organization on specific projects



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

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

Minimum requirements:
- Operations Management and Execution Project Management Collaborating across boundaries Cross Cultural Experience English Trial Planning and Feasibility Clinical Trial Set-up, Management & Conduct Regulatory Strategy

Education:
Degree in scientific or healthcare discipline.

Languages:
English (Oral and spoken), Fluent in local language (Japanese)
Global Drug Development
CD&A GDD
Japan
Tokyo
Research & Development
Full Time
Regular
No
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346425BR

Associate, JCDM

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