Compliance and Publishing Expert

5 days ago


London, Greater London, United Kingdom Novartis Full time

We are seeking a highly skilled Compliance and Publishing Expert to join our Regulatory Operations Team at Novartis. In this role, you will be responsible for ensuring compliance with worldwide Health Authority requirements, internal working practices, and guidelines for clinical deliverables and global regulatory submissions.

Key Responsibilities:
  • Publish high-quality clinical deliverables and global submission outputs per agreed timelines and in compliance with worldwide Health Authority requirements, internal working practices, and guidelines.
  • Support the implementation of new technology, tools, and processes, contribute to ongoing initiatives, and training, and help identify continuous improvement opportunities.
Requirements:
  • Bachelor's degree in life sciences or relevant discipline.
  • Fluency in English.
  • Clinical Report and Global Submission dossier publishing/compilation experience in the pharmaceutical or related industry.
  • Experience with electronic clinical document publishing standards/formats, electronic and global regulatory submission publishing standards/formats (e.g. eCTD, EU CTR).
  • Working knowledge of publishing tools (e.g., DXC, eCTD Xpress, Veeva), global submission validation tools, Document Management systems, Toolbox, HA electronic submission gateways, IRIS, CTIS, MS Office tools.
  • Familiarity with global Clinical and Regulatory HA requirements (e.g.,
  • Strong interpersonal and project management skills, and experience working in a complex, global cross-functional organization.
Estimated Salary: $120,000 - $150,000 per year

This role offers a competitive salary and benefits package, including health insurance, retirement plan, and paid time off.



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