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Do you dream of using your solid GCP (Good Clinical Practice) knowledge, process optimisation skills and quality mind-set in a highly professional and engaged global environment? Can you bring a ‘can-do’ attitude to support high quality in the development of innovative treatments for patients?
Then you could be our new Senior GCP Advisor in Clinical Quality. Apply now for this exciting job opportunity!
The position
The open position is in our Clinical Quality department in R&D (Research & Development) Quality. You will be part of a team that supports the global clinical organization with monitoring and trending of clinical quality data from Novo Nordisk’s clinical trials. The team is also responsible for handling and approval of action plans for GCP audit findings.
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, provide GCP advice and training, 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 a cademic degree in pharmacy, medicine, science, or similar and minimum 5 years of experience in clinical research and drug development.
In addition, you also need the following:
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.
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 department
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.
R&D Quality is part of the Development organisation in 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 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 & 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 Mathias Madsen, Manager of the Clinical Quality Department at +45 30755579 or Lisbeth Bonefeld, Director of Clinical Quality & Compliance at +45 30758096.
Deadline
13 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 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 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 Senior GCP Advisor in Clinical Quality. Apply now for this exciting job opportunity!
The position
The open position is in our Clinical Quality department in R&D (Research & Development) Quality. You will be part of a team that supports the global clinical organization with monitoring and trending of clinical quality data from Novo Nordisk’s clinical trials. The team is also responsible for handling and approval of action plans for GCP audit findings.
The main activities consist of:
- Perform the monitoring of clinical quality data to identify any potential trends that needs to be proactively addressed in the global clinical development organization
- Participate in creating the development road map for the systems and tools used to perform the monitoring of clinical quality data
- Work with global stakeholders on mitigating any identified trends
- Drive and ensure that action plans of a sufficient quality are developed for relevant GCP audit findings
- Participate in the continued optimization of the CAPA (Corrective and Preventive Actions) process and ensure an efficient collaboration with relevant stakeholders
- Share knowledge within the organization in the pursuit of continued improvement based on lessons learned from the outcomes of GCP audit findings
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, provide GCP advice and training, 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 a cademic degree in pharmacy, medicine, science, or similar and minimum 5 years of experience in clinical research and drug development.
In addition, you also need the following:
- Solid knowledge of GCP and other relevant regulations
- Proven experience within clinical quality assurance, trial management/monitoring, GCP audits or inspections
- Preferably experience with quality data monitoring/trending and experience with software development
- 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.
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 department
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.
R&D Quality is part of the Development organisation in 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 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 & 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 Mathias Madsen, Manager of the Clinical Quality Department at +45 30755579 or Lisbeth Bonefeld, Director of Clinical Quality & Compliance at +45 30758096.
Deadline
13 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 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 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 28.10.2022, 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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