Global Regulatory Publishing Specialist

1 month ago


London, Greater London, United Kingdom Novartis Full time
Global Regulatory Publishing Specialist

At Novartis, we're committed to reimagining medicine to improve and extend people's lives. Our Regulatory Operations Team is dedicated to delivering high-quality clinical documents and submissions that meet global regulatory requirements.

Key Responsibilities
  • Accountable for the preparation, publishing, and verification of clinical documents and submissions, ensuring compliance with worldwide regulatory requirements.
  • Collaborate with cross-functional teams, including Regulatory Affair Managers, Clinical Trial Leads, and Safety and Quality associates, to ensure seamless submission processes.
  • Support the implementation of new technology, tools, and processes to enhance global submission efficiency and quality.
  • Develop and maintain expertise in electronic clinical document publishing standards, formats, and global regulatory submission publishing standards.
Requirements
  • Bachelor's degree in life sciences or relevant discipline.
  • Proven experience in clinical report and global submission dossier publishing/compilation in the pharmaceutical or related industry.
  • Working knowledge of publishing tools, global submission validation tools, and Document Management systems.
  • Fluency in English and strong communication and business writing skills.
What We Offer

Novartis is committed to building an outstanding, inclusive work environment and diverse team representative of the patients and communities we serve. We offer a dynamic and supportive work environment, opportunities for growth and development, and a competitive compensation package.



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