Global Regulatory Coordinator
hace 5 días
Job Summary
The Global Regulatory Coordinator will be responsible for ensuring quality and compliant protocol registrations and results postings, as well as alignment with global registries.
About Us
Novartis Farmacéutica is a leading pharmaceutical company that strives to reimagine medicine and improve people's lives. Our purpose is to become the most valued and trusted medicines company in the world.
Why Work with Us?
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Responsibilities
- Stay current with global policies & regulations and operational application to ensure harmonization of Novartis transparency processes and standards.
- Independently represent Novartis to internal stakeholders and develop effective working relationships with global and country multidisciplinary leaders.
- Maintain Standard Operating Procedures and prepare for external & internal audits.
- Apply a continuous improvement mindset to drive best practices and productive processes.
- Demonstrate proficiency in Good Clinical Practice, Regulatory Processes, and clinical trial designs.
- Lead multidisciplinary teams in matrix environments and adapt to changing external environments.
Requirements
Bachelor's degree in a scientific discipline is preferred, and minimum 3 years pharmaceutical industry experience is required, including knowledge in disclosure.
Detailed knowledge of drug development, experience in writing protocols, and expertise in multiple clinical indications and/or therapy areas are desired.
Proven development skills in responsible positions within Clinical Research & Development, Data Management, Project Management, Medical Writing, Regulatory Affairs or related areas are essential.
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