Expert Regulatory Writer (80-100*)

329360BR
Oct 11, 2021
Switzerland

Job Description

160+ projects in development including over 60 new molecular entities, 26 major approvals, reaching over 769 million patients! And that’s just in 2020. This is your chance to help reimagine medicine in 2021.
Novartis is looking for dedicated individuals to join our Regulatory Writing team and contribute to developing our pipeline of drugs and biologics into innovative therapies for our patients worldwide. Read on for details about the role and how you can join a world-class organization at the forefront of the industry and how you can further your career In this role, you will write, review and/or manage the production of high quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. You will provide authoritative documentation-related consultancy to other line functions. You will coach/mentor and/or train less experienced writers.

Your responsibilities will include:
• Author, review and/or independently manage high quality clinical and safety documents for health authorities.
• Lead writing team for complex submissions, contributing to key messaging and pooling strategy, providing expert content guidance for) clinical submission documents, contributing to statistical analysis plans and presentation of outputs, and ensuring compliance of documentation to internal company standards and external regulatory guidelines.
• Provide content and strategic expertise on the clinical portions of the CTD to cross-functional teams.
• Program Writer for large and/or complex programs ensuring adequate medical writing resources are available for assigned program and consistency between documents.
• Lead process improvement in Regulatory Writing and Submissions and cross-functional initiatives and/or activities.
• Coach and/or mentor less experienced writers.

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

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Global Drug Development
GDO GDD
Switzerland
Basel
Research & Development
Full Time
Regular
No
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329360BR

Expert Regulatory Writer (80-100*)

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