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Would you like to join Regulatory Affairs (RA) and become part of an exciting environment where engaged people are committed gaining approval of Novo Nordisk’s medicines by regulatory authorities worldwide? Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting and challenging place to work. Apply today and join us for a life-changing career.
The position
As a Regulatory Professional you will be required to drive, coordinate and actively follow-up on several tasks with challenging and often overlapping timelines. You will be a member of cross functional project teams including study groups and submission teams, and as such, interact with a variety of stakeholders from different departments in Novo Nordisk. You will participate in the development of regulatory documentation for submission to Health Authorities, including briefing packages for meetings with Health Authorities, clinical trial applications, clinical trial protocols and reports and regulatory files for marketing authorisation. Furthermore, you will be expected to provide regulatory input, be proactive, challenge the discussions and contribute to project team decisions. You will among others interact with medical and non-clinical specialists, statisticians, and medical writers. You will report to the Director of RA Diabetes and Obesity II department and take active part in department related activities, including improvement projects across RA.
Qualifications
We expect you to have a university degree in life science and 1-4 years of regulatory affairs experience or other relevant drug development experience.
As a person you are a team player, well organized and have solid problem-solving capabilities, just as you show a can-do attitude and never lose your strategic focus. You can keep your spirits high even when under pressure. You are a skilled communicator who can cooperate at any organizational level. Finally, you are comfortable using your fluent written and spoken English daily.
About the department
In the RA Diabetes and Obesity II department, we are responsible for regulatory strategies for diabetes and obesity projects, in both early and late stage of development. We are 11 dedicated and highly engaged employees in the department belonging to the area of RA Diabetes & Obesity that includes three different departments. We work as an integrated part of the global development and research projects and play a key role in the cross-functional teams. We are responsible for the regulatory strategy and provide regulatory expertise and tactics to the product development plans. We drive label development, health authority interactions and clinical trial applications. We have a strong collaboration with our affiliates and global stakeholders in the regulatory teams. We are currently looking for a new colleague who is enthusiastic about working in a dynamic environment on worldwide submissions and approvals of new medicines.
Working at Novo Nordisk
At Novo Nordisk, we use our skills, dedication, and ambition to help people with chronic diseases such as Diabetes, Obesity, NASH, CVD, Rare Endocrine Disorders as well as Rare Blood Disorders. We offer the chance to be part of a truly global and highly diverse workplace, where passion and engagement are met with opportunities for professional and personal development.
Contact
For further information, please contact Magdalena Jayatissa at +45 3075 4249.
Deadline
6 November 2022 but the candidates will be invited for interviews on an on-going 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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The position
As a Regulatory Professional you will be required to drive, coordinate and actively follow-up on several tasks with challenging and often overlapping timelines. You will be a member of cross functional project teams including study groups and submission teams, and as such, interact with a variety of stakeholders from different departments in Novo Nordisk. You will participate in the development of regulatory documentation for submission to Health Authorities, including briefing packages for meetings with Health Authorities, clinical trial applications, clinical trial protocols and reports and regulatory files for marketing authorisation. Furthermore, you will be expected to provide regulatory input, be proactive, challenge the discussions and contribute to project team decisions. You will among others interact with medical and non-clinical specialists, statisticians, and medical writers. You will report to the Director of RA Diabetes and Obesity II department and take active part in department related activities, including improvement projects across RA.
Qualifications
We expect you to have a university degree in life science and 1-4 years of regulatory affairs experience or other relevant drug development experience.
As a person you are a team player, well organized and have solid problem-solving capabilities, just as you show a can-do attitude and never lose your strategic focus. You can keep your spirits high even when under pressure. You are a skilled communicator who can cooperate at any organizational level. Finally, you are comfortable using your fluent written and spoken English daily.
About the department
In the RA Diabetes and Obesity II department, we are responsible for regulatory strategies for diabetes and obesity projects, in both early and late stage of development. We are 11 dedicated and highly engaged employees in the department belonging to the area of RA Diabetes & Obesity that includes three different departments. We work as an integrated part of the global development and research projects and play a key role in the cross-functional teams. We are responsible for the regulatory strategy and provide regulatory expertise and tactics to the product development plans. We drive label development, health authority interactions and clinical trial applications. We have a strong collaboration with our affiliates and global stakeholders in the regulatory teams. We are currently looking for a new colleague who is enthusiastic about working in a dynamic environment on worldwide submissions and approvals of new medicines.
Working at Novo Nordisk
At Novo Nordisk, we use our skills, dedication, and ambition to help people with chronic diseases such as Diabetes, Obesity, NASH, CVD, Rare Endocrine Disorders as well as Rare Blood Disorders. We offer the chance to be part of a truly global and highly diverse workplace, where passion and engagement are met with opportunities for professional and personal development.
Contact
For further information, please contact Magdalena Jayatissa at +45 3075 4249.
Deadline
6 November 2022 but the candidates will be invited for interviews on an on-going 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 10.10.2022, 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 |
| 1. juli 2024 | 66 |
| 30. juni 2024 | 71 |
| 29. juni 2024 | 71 |
| 28. juni 2024 | 75 |
| 27. juni 2024 | 72 |
| 26. juni 2024 | 70 |
| 25. juni 2024 | 71 |
| 24. juni 2024 | 70 |
| 23. juni 2024 | 71 |
| 22. juni 2024 | 71 |
| 21. juni 2024 | 72 |
| 20. juni 2024 | 73 |
| 19. juni 2024 | 71 |
| 18. juni 2024 | 67 |
| 17. juni 2024 | 65 |
| 16. juni 2024 | 71 |
| 15. juni 2024 | 71 |
| 14. juni 2024 | 71 |
| 13. juni 2024 | 68 |
| 12. juni 2024 | 64 |
| 11. juni 2024 | 65 |
| 10. juni 2024 | 63 |
| 9. juni 2024 | 66 |
| 8. juni 2024 | 66 |
| 7. juni 2024 | 63 |
| 6. juni 2024 | 59 |
| 5. juni 2024 | 55 |
| 4. juni 2024 | 55 |
| 3. juni 2024 | 55 |
| 2. juni 2024 | 57 |