Regulatory Document Preparation Specialist
1 week ago
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 UsNovo 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.
- 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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Gladsaxe, Gladsaxe Municipality, Denmark beBee Careers Full timeJob OverviewWe are seeking an experienced Clinical Document Specialist to drive the preparation of complex clinical documents and oversee project management.This role requires expertise in planning, development, and oversight of regulatory documents, including study protocols, informed consent forms, investigator's brochures, PIPs, clinical summaries,...
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