Submission Manager
Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger
Søborg
Are you passionate about clinical trial submissions? Do you possess a talent for oversee-ing project management and ensuring compliance with global requirements? If so, we have an exciting opportunity for you to join our team as a Submission Manager at Novo Nordisk. This is a great opportunity to be part of defining our future processes and make a difference for clinical trials teams. Read more and apply today for a life-changing ca-reer. The position As a Submission Manager at Novo Nordisk, you will lead and be accountable for the submission of initial Clinical Trial Applications (CTAs) and amendments to Health Authorities (HAs) and Ethics Committees (ECs) in alignment with business needs and priorities. This new role has been introduced to strengthen the current process and establish a center of excellence. We are looking for 4 people to join our team, and these positions will be based in Søborg, Denmark. You will collaborate closely with various stakeholders across Development and Affiliate to ensure timely and compliant submissions on a global scale. Your key responsibilities will include: Leading the CTA submission process effectively and applying best practices to en-sure timely submission of CTAs. Ensuring CTA submission is in compliance with all applicable requirements world-wide and driving better practice and consistency across trials. Coordinating the preparation and monitoring the compilation of CTA documents for submission of initial CTAs and amendments. Providing daily support to the team in analysis and problem-solving related to CTA submission activities. Providing continuous input to CTA process and system improvements to drive best practice and efficiency gains across CTA submissions. Qualification
To succeed in this role, you should: Hold a Bachelor's or Master's degree in Life Science or a relevant field. Have experience within the pharmaceutical or medical device industry. Demonstrate project management expertise and experience in managing tri-als/projects. Exhibit experience in cross-functional organizational work, representing trial man-agement views. Possess extensive experience in all operational aspects of start-up, planning, con-duct, and finalization of CTAs. Be proficient in English. As a person, you bring strong project management skills to the table, along with flexibility and cross-cultural awareness. You have the ability to inspire and motivate stakeholders, and your overall overview and analytical capabilities are exemplary. Moreover, your good communication, presentation, negotiation, and influential skills make you a valuable asset. Additionally, you possess the ability and willingness to adjust quickly to new situations in a continuously developing environment. About the department You will be part of a dynamic and dedicated team responsible for running all clinical devel-opment activities from initial planning of clinical trials towards authority submission. CTA Manage-ment is a department in constant development, and we are working closely with our stakeholders to continuously improve our processes to adapt and ensure compliance with the increasingly complex regulatory environment.
We offer interesting and challenging assignments and good opportunities for continuous personal and professional development. 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 experi-mentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufactur-ing, marketing and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Henriette Westphal, Associate Director at +. Deadline
5 January 2025. 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. 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.
To succeed in this role, you should:
We offer interesting and challenging assignments and good opportunities for continuous personal and professional development. 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 experi-mentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufactur-ing, marketing and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Henriette Westphal, Associate Director at +. Deadline
5 January 2025. 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. 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 "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 10.12.2024, 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.
- Apoteker
- Søborg
Lignende jobs
-
CLOSED - Regulatory Affairs Specialist
THE POSITION IS CLOSED AND DO NOT ACCEPT APPLICATIONSCerebriu, an award-winning health-tech startup, is at the forefront of revolutionizing the field of radiology through cutting-edge AI softwa..Få mere info- Apoteker
- København
-
CLOSED - Executive Management Assistant at Xellia ...
THE POSITION IS CLOSED AND DO NOT ACCEPT APPLICATIONS NO LONGERAre you ready to make a difference and play a crucial role in an organization dedicated to saving lives? Are you the person who ca..Få mere info- Apoteker
- København
-
Manager, Global Regulatory Affairs, Operations, Su...
At [xxxxx], we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and th..Få mere info- Apoteker
- København
-
Vigilance Specialist, Global Regulatory Affairs
Are you the go-to person when it comes to reporting requirements for medical devices? Would you like to play a key role in maintaining [xxxxx]’s continuous regulatory compliance by co-owning the vig..Få mere info- Apoteker
- Ballerup
Statistik over udbudte jobs som apotekere i Søborg
Herunder ser du udviklingen i udbudte apoteker i Søborg over tid. Bemærk at jobs der ikke har en bestemt geografi ikke er medtaget i tabellen. I den første kolonne ser du datoen. I den næste kolonne ser du det samlede antal apotekere.
Se flere statistikker her:
Statistik over udbudte apotekere i Søborg over tid
| Dato | Alle jobs som apotekere |
|---|---|
| 18. januar 2025 | 7 |
| 17. januar 2025 | 7 |
| 16. januar 2025 | 7 |
| 15. januar 2025 | 7 |
| 14. januar 2025 | 7 |
| 13. januar 2025 | 6 |
| 12. januar 2025 | 10 |
| 11. januar 2025 | 10 |
| 10. januar 2025 | 10 |
| 9. januar 2025 | 9 |
| 8. januar 2025 | 7 |
| 7. januar 2025 | 7 |
| 6. januar 2025 | 7 |
| 5. januar 2025 | 9 |
| 4. januar 2025 | 9 |
| 3. januar 2025 | 9 |
| 2. januar 2025 | 9 |
| 1. januar 2025 | 10 |
| 31. december 2024 | 10 |
| 30. december 2024 | 10 |
| 29. december 2024 | 11 |
| 28. december 2024 | 11 |
| 27. december 2024 | 11 |
| 26. december 2024 | 11 |
| 25. december 2024 | 11 |
| 24. december 2024 | 12 |
| 23. december 2024 | 12 |
| 22. december 2024 | 12 |
| 21. december 2024 | 12 |
| 20. december 2024 | 12 |
| 19. december 2024 | 10 |