Job Description

900! That is the approximate number of individual regulatory documents the dynamic team at Regulatory Writing and Submissions (RWS) planned, developed and wrote. And that\xe2\x80\x99s just in 2019! Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians and project managers across 6 countries and support Novartis in its mission to bring innovative medicines to patients worldwide. You will collaborate with colleagues from Statistics, Data Management and Clinical Development and have the opportunity to analyze data and derive key messaging to secure approvals from Health Authorities. Read on for details about the role and how you can join a world-class organization at the forefront of the industry to advance your career.

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.

• Core member of Clinical Trial Team (CTT) / contributor to Safety Management Team. Documentation specialist in CTTs and Clinical Submission Teams (CST) to ensure compliance of documentation to internal company standards and external regulatory guidelines.

• Program Writer ensuring adequate medical writing resources are available for assigned program and consistency between documents.

• 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.

• Contribute to process improvement in RWS 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.