Clinical Writer Specialist

2 weeks ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time
About the Job

We are seeking an experienced Clinical Writer to join our team at Novo Nordisk. As a key member of our Clinical Reporting department, you will play a vital role in driving the preparation of complex clinical documents and acting as a project manager.

Your primary responsibility will be to lead tasks such as planning, development, and oversight 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 according to business needs.

As a Clinical Writer Specialist, you will represent Clinical Reporting on cross-functional project teams and provide guidance on regulatory document requirements and optimal data presentation.



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