Regulatory Document Preparation Specialist

1 week ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

Take on the role of Regulatory Document Preparation Specialist at Novo Nordisk A/S and play a crucial part in driving the preparation of complex clinical documents that meet regulatory requirements.

About Us

Novo Nordisk A/S is a leading healthcare company focused on defeating diabetes and other serious chronic conditions. We value continuous learning, being bold, and striving for simplicity.

In this role, you will:

  • Lead the preparation of regulatory documents, including study protocols, informed consent forms, investigator's brochures, PIPs, clinical summaries, paediatric plans, briefing packages, and responses to health agency questions.
  • Collaborate with other job functions across Development to ensure accurate reporting of source information and data.
  • Represent Clinical Reporting on cross-functional project teams and provide guidance on regulatory document requirements and optimal data presentation.
Key Responsibilities
  • Drive the preparation of regulatory documents, ensuring adherence to regulatory requirements.
  • Develop and improve internal processes, promoting the sharing of best practices across areas.
  • Mentor and train other medical writers, ensuring high-quality documents within your team and across the organization.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.



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