Global Regulatory Publishing Specialist

3 weeks 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 at the forefront of this mission, and we're seeking a talented Global Regulatory Publishing Specialist to join our team.

This role offers a unique blend of hybrid working and collaboration with our global teams. As a Global Regulatory Publishing Specialist, you'll be accountable for publishing, verification, dispatch, and coordination of HA compliant, worldwide HA submissions in support of Novartis global product portfolios.

You'll work closely with our cross-functional teams to produce high-quality, clinical deliverables and global submission outputs per agreed timelines and in compliance with worldwide HA requirements, internal working practices, and guidelines.

We're looking for a skilled professional with experience in clinical report and global submission dossier publishing/compilation in the pharmaceutical or related industry. You'll have a strong working knowledge of publishing tools, global submission validation tools, Document Management systems, and HA electronic submission gateways.

As a Global Regulatory Publishing Specialist, you'll have the opportunity to contribute to ongoing initiatives and training, and help identify continuous improvement opportunities. If you're passionate about regulatory publishing and have a strong commitment to quality and excellence, we encourage you to apply.

Key Responsibilities
  • Electronically prepare, publish, quality review, validate, dispatch, and archive clinical deliverables and global regulatory submissions
  • Produce high-quality, clinical deliverables and global submission outputs per agreed timelines and in compliance with worldwide HA requirements
  • Support the implementation of new technology, tools, and processes
  • Contribute to ongoing initiatives and training
  • Help identify continuous improvement opportunities
Requirements
  • Bachelor's degree in life sciences or relevant discipline
  • Clinical report and global submission dossier publishing/compilation experience in the pharmaceutical or related industry
  • Working knowledge of publishing tools, global submission validation tools, Document Management systems, and HA electronic submission gateways
  • Strong interpersonal and project management skills
  • Strong communication and business writing skills
  • Fluency in English
What We Offer

At Novartis, we offer a dynamic and inclusive work environment, with opportunities for professional growth and development. We're committed to building a diverse team that reflects the patients and communities we serve.

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