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’s 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:

• Independently write and QC/review patient narratives.
• Independently lead narrative projects. May coach other writers.
• Follow and track clinical trial milestones and resource requirements for assigned projects.
• Act independently as document consultant in clinical trial teams to ensure
• Compliance of documentation to internal company standards and external regulatory guidelines.
• Act as liaison between clinical trial teams and publishing to ensure timely delivery of final documents for publishing.
• Support process improvement initiatives. Maintain audit, SOP and training compliance.
  
  

Commitment to Diversity & Inclusion:

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

Minimum Requirements

• At least 2 years of relevant experience.
• Good document creation and editing skills.
• Basic knowledge of clinical documentation.
• Good project management skills.
• Basic knowledge of clinical development.

Apply through this Link