GCP Advisor Specialist for Clinical Inspections, R&D Quality
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Søborg
Do you dream of using your solid GCP knowledge, process optimisation skills and quality mind-set in a highly professional and engaged global environment? Can you bring a ‘can-do’ attitude to successfully lead the clinical inspection process – keeping calm under pressure and with an ability to spread that calmness to people around you? Then you could be our new GCP Advisor Specialist. About the area
Clinical Inspections is one of three sister departments in Clinical Quality & Compliance, which is part of R&D Quality in Novo Nordisk.
We play a vital role in supporting the drug development process to ensure high quality as well as fit-for-purpose processes.
In Novo Nordisk, we have an ambitious drug development program, and we work in a global setting with focus on delivering viable products that make a difference to patients and ultimately benefit society. The position
The open position is in the Clinical Inspections department, located in Søborg. You will be part of a team that supports the global clinical organization before, during and after inspections and provides leadership and guidance to reach the best possible outcome of our inspections. The department core activities consist of: • Leading the clinical inspection process – providing training, tools, and support
• Hosting or co-hosting sponsor GCP inspections from health authorities
• Facilitating that solid CAPAs are defined and implemented for inspection findings
• Knowledge sharing to the global organization on inspection findings and learnings
• Charing global inspection readiness activities As we support the global organization, some travel should be expected (on average around 10 days per year). Apart from these core activities, you will also have cross-functional responsibilities within the Clinical Quality & Compliance Area. Here, we support the trial teams globally in a proactive manner, ensuring that Novo Nordisk is in compliance with GCP and other relevant external and internal requirements in an optimal way.
We participate in improvement projects, we provide GCP advice and training, we handle potential serious breaches and ensure proper follow-up on findings from GCP Audits. You will be part of a dynamic area, where the positions offer high impact, and where you are expected to take ownership and responsibility for setting the right quality level in the global organisation. Qualifications
You have a degree in pharmacy, medicine, science or similar and a strong command of written and spoken English.
You have a minimum of 5 years of experience in clinical research and drug development, as well as solid knowledge of GCP and other relevant regulations.
Experience within clinical quality assurance, trial management/monitoring, GCP Audits or Inspections is required. You are a team player with strong communication and interpersonal skills. You have a flexible mindset and thrive with a schedule that can be difficult to predict.
Finally, you have a strong ability to keep calm under pressure and can work with people around youto spread that calmness. Millions rely on us
To work for Novo Nordisk, you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer you to be a part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development. Contact
For further information, please contact Pia Pamperin at +45 3075 9337. Deadline June 18th, 2023, Please note that applications will be reviewed continuously, and interviews will be planned as soon as a suitable candidate is identified. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We will be screening, interviewing and hiring on an ongoing basis.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Clinical Inspections is one of three sister departments in Clinical Quality & Compliance, which is part of R&D Quality in Novo Nordisk.
We play a vital role in supporting the drug development process to ensure high quality as well as fit-for-purpose processes.
In Novo Nordisk, we have an ambitious drug development program, and we work in a global setting with focus on delivering viable products that make a difference to patients and ultimately benefit society. The position
The open position is in the Clinical Inspections department, located in Søborg. You will be part of a team that supports the global clinical organization before, during and after inspections and provides leadership and guidance to reach the best possible outcome of our inspections. The department core activities consist of: • Leading the clinical inspection process – providing training, tools, and support
• Hosting or co-hosting sponsor GCP inspections from health authorities
• Facilitating that solid CAPAs are defined and implemented for inspection findings
• Knowledge sharing to the global organization on inspection findings and learnings
• Charing global inspection readiness activities As we support the global organization, some travel should be expected (on average around 10 days per year). Apart from these core activities, you will also have cross-functional responsibilities within the Clinical Quality & Compliance Area. Here, we support the trial teams globally in a proactive manner, ensuring that Novo Nordisk is in compliance with GCP and other relevant external and internal requirements in an optimal way.
We participate in improvement projects, we provide GCP advice and training, we handle potential serious breaches and ensure proper follow-up on findings from GCP Audits. You will be part of a dynamic area, where the positions offer high impact, and where you are expected to take ownership and responsibility for setting the right quality level in the global organisation. Qualifications
You have a degree in pharmacy, medicine, science or similar and a strong command of written and spoken English.
You have a minimum of 5 years of experience in clinical research and drug development, as well as solid knowledge of GCP and other relevant regulations.
Experience within clinical quality assurance, trial management/monitoring, GCP Audits or Inspections is required. You are a team player with strong communication and interpersonal skills. You have a flexible mindset and thrive with a schedule that can be difficult to predict.
Finally, you have a strong ability to keep calm under pressure and can work with people around youto spread that calmness. Millions rely on us
To work for Novo Nordisk, you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer you to be a part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development. Contact
For further information, please contact Pia Pamperin at +45 3075 9337. Deadline June 18th, 2023, Please note that applications will be reviewed continuously, and interviews will be planned as soon as a suitable candidate is identified. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We will be screening, interviewing and hiring on an ongoing basis.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 5.6.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Søborg
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