337014BR
Jan 23, 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 author, review and manage high quality clinical and safety documents: complex Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Risk Management Plans (RMP), submission documents (e.g., summaries of clinical efficacy and safety, summaries of clinical pharmacology and biopharmaceutics).
· Core member of Clinical Trial Team (CTT) / contributor to Safety Management Team.
· Major contributor to planning of data analyses and presentation used in CSRs and submission documents.
· Documentation specialist in CTTs and CSTs to ensure compliance of documentation to internal company standards and external regulatory guidelines. Provide content expertise and guidance for clinical portions of the CTD.
· Program Writer ensuring adequate medical writing resources are available for assigned program and consistency between documents. Extended member of International Clinical Team (ICT)
· Lead Writer for simple submissions, contributing to key messaging and pooling strategy, providing content guidance, and ensuring compliance of documentation to internal company standards and external regulatory guidelines. Core member of Clinical Submission Team (CST).
· Contribute to process improvement in DE and/or cross-functional initiatives or activities. Coach and/or mentor less experienced writers.
· Leader in cross-functional communication to optimize feedback and input towards high quality documents. Maintain audit, SOP and training compliance.

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:
· Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.
·≥ 4 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus in-depth knowledge of medical writing processes.
· Advanced knowledge of and experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements). Advanced knowledge of and repeat experience in global registration of drugs (complex submissions).
· Excellent communication skills (written, verbal, presentations). Advanced knowledge of biostatistics principles.
· Strong ability to prioritize and manage multiple demands and projects. Ability to define and solve complex problems (“Problem-solver”)
· Broad knowledge and future oriented perspective
· Ability to drive and manage organizational and team performance across cultures. Proven track record in matrix environment
· Some experience in managing global, cross-functional teams or simple global projects. Ability to motivate and coach people.

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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337014BR

Senior Regulatory Writer

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