Clinical Supplies Specialist
6 days ago
At Novo Nordisk A/S, we are seeking a dedicated Clinical Supplies Set-up Professional to support our clinical trial supply operations.
The Position
As a Clinical Supplies Set-up Professional, you will be part of a team responsible for preparing clinical trials for supply execution. Your primary responsibilities will include:
- Ensuring clinical supply input to clinical trial protocols
- Creating trial master data, clinical label text, and trial-specific manuals for clinical sites and aligned with product specifications and regulatory requirements
- Ensuring documents are ready for clinical trial application to authorities
To succeed in this role, you will establish and maintain collaboration with various stakeholders across Novo Nordisk. Additionally, you will work with experienced colleagues to develop and improve processes.
Qualifications
To be successful in this position, you have:
- A MSc degree in Natural, Health, or Pharmaceutical Sciences or similar
- Experience in the pharma industry is a plus
- A quality mindset and experience with regulatory requirements, e.g., GCP and GMP
- Data-driven, analytical, and methodical capabilities with flair for IT systems and tools
- Excellent collaboration and communication skills with fluency in English
As a person, you take pride in consistently delivering high-quality work on time and in a proactive manner. You can prioritize your assignments in an ever-changing and dynamic environment. You are a team player who aspires to continuously learn and take challenges as opportunities to grow.
About the Department
The Clinical Supplies Trial Set-up department consists of six teams who prepare clinical trials for supply execution by forecasting product demand, simulating trial supply execution, setting up supply systems, and preparing regulatory documents for CTA.
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