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Do you dream of using your solid Good Clinical Practice (GCP) knowledge, process optimisation skills and quality mind-set in a highly professional and engaged global environment? Can you bring a positive attitude to successfully lead the clinical inspection process while remaining calm under pressure?
Then you could be our new GCP Advisor Specialist for Clinical Inspections, Research & Development (R&D) Quality. Apply now for this exciting job opportunity!
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 main activities consist of:
Apart from these core activities, you will also have cross-functional responsibilities within the Clinical Quality & Compliance Area in R&D Quality. Here, we support the trial teams globally in a proactive manner, ensuring that Novo Nordisk follows 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.
Qualifications
To be successful in this role, you need to have:
As a person, you are proactive, courageous and have strong communication and interpersonal skills. Being organised, quality-conscious, and detail-oriented without losing the big picture is also important. You are a team player and thrive working across departments in an international organisation. Not least, you are flexible by nature and can see yourself thriving 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 you to spread that calmness.
About the area
R&D Quality is part of the development organisation at Novo Nordisk, and 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.
In R&D Quality, we are responsible for our Quality Management System, we provide GCP support globally, we lead the GCP inspections, we perform vendor assessments, assess, and try to impact external clinical requirements and provide advanced GCP training to the global organisation. We take active part in cross organisational improvement projects and provide general quality and compliance support to our global organisation.
Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.
Contact
For further information, please contact Pia Pamperin, Manager Clinical Inspections at +45 3075 9337.
Deadline
06 November 2022. We will be screening, interviewing, and hiring on an ongoing basis.
You do not need to attach a cover letter to your application, but please include a few sentences about your motivation in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
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.
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Then you could be our new GCP Advisor Specialist for Clinical Inspections, Research & Development (R&D) Quality. Apply now for this exciting job opportunity!
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 main 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 Corrective and Preventive Actions (CAPAs) are defined and implemented for inspection findings
- Knowledge sharing to the global organization on inspection findings and learnings
- Charing global inspection readiness activities
Apart from these core activities, you will also have cross-functional responsibilities within the Clinical Quality & Compliance Area in R&D Quality. Here, we support the trial teams globally in a proactive manner, ensuring that Novo Nordisk follows 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.
Qualifications
To be successful in this role, you need to have:
- Academic degree in pharmacy, medicine, science or similar
- Minimum of 5 years of experience in clinical research and drug development
- Solid knowledge of GCP and other relevant regulations
- Proven experience within clinical quality assurance, trial management/monitoring, GCP audits or inspections
- Strong command of written and spoken English
As a person, you are proactive, courageous and have strong communication and interpersonal skills. Being organised, quality-conscious, and detail-oriented without losing the big picture is also important. You are a team player and thrive working across departments in an international organisation. Not least, you are flexible by nature and can see yourself thriving 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 you to spread that calmness.
About the area
R&D Quality is part of the development organisation at Novo Nordisk, and 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.
In R&D Quality, we are responsible for our Quality Management System, we provide GCP support globally, we lead the GCP inspections, we perform vendor assessments, assess, and try to impact external clinical requirements and provide advanced GCP training to the global organisation. We take active part in cross organisational improvement projects and provide general quality and compliance support to our global organisation.
Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.
Contact
For further information, please contact Pia Pamperin, Manager Clinical Inspections at +45 3075 9337.
Deadline
06 November 2022. We will be screening, interviewing, and hiring on an ongoing basis.
You do not need to attach a cover letter to your application, but please include a few sentences about your motivation in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
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.
Print job Send to e-mail
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 19.10.2022, 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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Statistik over udbudte jobs som øvrige i Søborg
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Statistik over udbudte øvrige i Søborg over tid
| Dato | Alle jobs som øvrige |
|---|---|
| 2. juli 2024 | 69 |
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| 30. juni 2024 | 71 |
| 29. juni 2024 | 71 |
| 28. juni 2024 | 75 |
| 27. juni 2024 | 72 |
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| 6. juni 2024 | 59 |
| 5. juni 2024 | 55 |
| 4. juni 2024 | 55 |
| 3. juni 2024 | 55 |
| 2. juni 2024 | 57 |