Looking for a dynamic and challenging role within clinical process management? Do you thrive when using your in depth GCP knowledge, process optimisation skills and quality mind-set in a highly professional and engaged global environment? If so, then we have the perfect opportunity for you!
Apply now and join a great team where focus is on collaboration, individual development and complex problem solving.
About the Department
The Clinical Quality Management System (QMS) department is one of four sister departments in Clinical Quality, which is part of R&D Quality at Novo Nordisk. We play a vital role in supporting the drug development process to ensure high quality as well as fit-for-purpose processes. At 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
As a GCP Advisor Specialist in our Clinical QMS department, your primary responsibility is to manage updates to our standard operating procedures (SOP’s) covering the Establish Clinical Evidence process by ensuring compliance with GCP and regulatory requirements. Furthermore, you will be handling new external requirements and taking lead on impact assessments in cooperation with the NN process manager and topic lead.
You will be serving as a quality and process advisor, where you will support colleagues and projects regarding quality and ensuring a quality mind-set. Your continuous focus on quality improvement will be an essential aspect of your job.
Your main responsibilities will include:
You will be part of a dynamic and hybrid team with colleagues working from Denmark and India. This position is based in Søborg, Denmark. The position offers high impact, flexibility, and you are expected to take ownership and responsibility for setting the right quality level in the global organisation.
Qualifications
You have a degree in nursing, pharmacy, medicine, science or similar and a strong command of written and spoken English. You have at least 8 years of experience in clinical research and drug development, as well as a strong knowledge of GCP and other relevant regulations. Experience within clinical quality assurance, trial management/monitoring, or GCP Audits is an advantage.
To excel in this role, we are looking for someone with the following qualifications:
Working at Novo Nordisk
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world.
Contact
For further information, please contact Kate Bruun Lunding at +45 3077 5507 or get to know us better by visiting www.novonordisk.com/careers
Deadline
5 May 2024
We will be screening and interviewing on an ongoing basis.
We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us! Together, we go further.
Together, we're life changing.
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