347426BR
Jun 21, 2022
China

Job Description

500+ Ongoing clinical trials;160+ Projects in clinical development;80+ Major submissions planned 2020-
2022. Novartis GDD (Global Drug Development) oversees the development of new medicines
discovered by our researchers and partners. It drives breakthrough innovations to improve and extend
the lives of millions.

Your key responsibilities:
Your responsibilities include, but are not limited to:
· To write and/or edit under guidance high quality clinical and safety documents: non registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Clinical Trial Registration Documents or Patient Narratives
· May act as documentation consultant in CTTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.
· May act as liaison between CTTs and publishing teams to ensure timely delivery of final documents for publishing. · Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt

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

What you’ll bring to the role:
· Operations Management and Execution
· Project Management
· Representing the organization
· Collaborating across boundaries
· English



Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Join our Novartis network: If this role is not suitable to your experience or career goals but
you wish to stay connected to hear more about Novartis and our career opportunities, follow us via Novartis Group WeChat Recruitment Account.
Global Drug Development
GDO GDD
China
Shanghai
Research & Development
Full Time
Regular
No
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347426BR

Regulatory Writer

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