Senior Quality Consultant for Clinical Research Excellence
5 days ago
At Novo Nordisk A/S, we are committed to delivering high-quality drug development processes that meet regulatory requirements.
Job DescriptionThis is an exciting opportunity to work as a Principal GCP Advisor in our Clinical Quality Management System (QMS) department. As a key member of the team, you will be responsible for ensuring regulatory compliance when transforming written standard operating procedures (SOPs) into seamless digital / system-based processes.
You will provide quality and process guidance to our Corporate Vice President for R&D Quality and support colleagues working within the Establish Clinical Evidence process by ensuring direction for compliance with GCP and regulatory requirements.
- Key Responsibilities:
- Supporting the digitalisation of key processes and procedures
- Verifying and approving Standard Operating Procedures (SOPs) and ensuring compliance with external & internal requirements
- Ensuring global consistency and compliance in clinical development processes through process documentation, information sharing, and guidance
- Being the quality partner for improvement projects
- Providing support to stakeholders inside and outside R&D Quality during GCP inspections as applicable
- Attending stakeholder meetings and raise/present/discuss relevant quality concerns
- Handling and processing external clinical requirements impacting the clinical area
The ideal candidate will have a strong command of written and spoken English, a master degree in nursing, pharmacy, medicine, science or similar, and at least 12 years of experience in clinical research and drug development. In addition, the candidate should have subject matter expertise of GCP and other relevant regulations such as the EMA Guideline on computerised systems and electronic data in clinical trials.
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob Description:">We are seeking a highly skilled Senior GCP Advisor to join our Clinical QMS department. As a key member of the team, you will be responsible for ensuring compliance with GCP and regulatory requirements.The successful candidate will have at least 8 years of experience in clinical research and drug development, as well as a strong knowledge...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeSelect how often (in days) to receive an alert: Create AlertGCP Advisor Specialist: Drive Excellence in Clinical Quality Process ManagementCategory: QualityLocation: Søborg, Capital Region of Denmark, DKLooking for a dynamic and challenging role within clinical process management? Do you thrive when using your in-depth GCP knowledge, process optimisation...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeSelect how often (in days) to receive an alert: Create Alert GCP Advisor Specialist: Drive Excellence in Clinical Quality Process Management Category: Quality Location: Søborg, Capital Region of Denmark, DK Looking for a dynamic and challenging role within clinical process management? Do you thrive when using your in-depth GCP knowledge, process...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeNovo Nordisk A/S is a dynamic company in an even more dynamic industry. We are seeking a highly skilled Principal GCP Advisor to join our Clinical Quality Management System (QMS) department.About the TeamAs a key member of the team, you will be responsible for ensuring regulatory compliance when transforming written standard operating procedures (SOPs) into...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeSelect how often (in days) to receive an alert: Create Alert Principal GCP Advisor to Drive Digital Quality Excellence Category: Quality Location: Søborg, Capital Region of Denmark, DK Looking for a dynamic and challenging role within clinical process management? Do you thrive when using your expertise in GCP, process optimisation skills and quality...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeSelect how often (in days) to receive an alert: Create AlertPrincipal GCP Advisor to Drive Digital Quality ExcellenceCategory: QualityLocation: Søborg, Capital Region of Denmark, DKLooking for a dynamic and challenging role within clinical process management? Do you thrive when using your expertise in GCP, process optimisation skills and quality mind-set in...
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