Semaglutide CVOT Regulatory Affairs Specialist
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Søborg
Join Regulatory Affairs and become part of an exciting environment where engaged people are committed gaining approval of Novo Nordisk’s medicines by regulatory authorities across the globe. We have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs an interesting and challenging place to work. We are currently looking for a Semaglutide Cardiovascular Outcomes Trial (CVOT) RA (Regulatory Affairs) Specialist with a strong scientific background and a genuine interest in being part of the future within cardiometabolic and renal disease. About the department
RA Semaglutide is responsible for defining and driving regulatory strategies for our Semaglutide projects in all phases of development. We are dedicated and highly engaged employees in the department belonging to the RA Semaglutide area. 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 Semaglutide 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. The job
As a Semaglutide CVOT RA Specialist you will be responsible for driving several regulatory tasks with challenging and often overlapping timelines. You will be working closely with Global Regulatory Lead during worldwide submissions. Specifically, you will have a critical responsibility in the submission and approval process, and work with the cross-functional teams toward forming strategies and responding questions to major Health Authorities, and by that, securing progress toward regulatory approvals. You will be involved in critical CVOT strategic discussions in the project, where you will be expected to contribute to regulatory strategies and tactics, be proactive and bold, challenge the discussions and contribute to business-critical decisions. You will, among others, interact with project management, medical and non-clinical specialists, statisticians, and medical writers. You could also contribute to projects for the improvement and maintenance of regulatory processes across the organisation. You will be expected to contribute to developing younger colleagues, sharing your knowledge and experience and contribute to high performance of the regulatory project team.
Qualifications
We expect you have a Master of Science degree in pharmaceutical or life sciences with 6-8 years relevant experience and/or PhD. with 4-5 years of relevant working experience. From your career you have solid experience of handling regulatory documentation for pharmaceutical development within the quality, non-clinical or clinical area. You have experience interacting directly with regulatory authorities on an international scale. You have strong negotiation skills and a sound business understanding. You also know how to set direction, lead, and motivate your team to work for joint objectives. At the same time, you are the team player who assists your colleagues. As a person you are well-organised and have solid problem-solving capabilities, just as you show a winning attitude and never lose your strategic focus. You can keep your spirits high even when under pressure. You are a skilled communicator who can work at any organisational level. Finally, you are comfortable using your fluent written and spoken English.
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/CKD, Rare Endocrine Disorders, and 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 the hiring manager: Emel Mashaki Ceyhan Phone: +45 3448 1007
Deadline
Deadline 5 February 2023.
Please note that applications will be reviewed continuously, and interviews will be planned as soon as a suitable candidate is identified. 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.
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.
RA Semaglutide is responsible for defining and driving regulatory strategies for our Semaglutide projects in all phases of development. We are dedicated and highly engaged employees in the department belonging to the RA Semaglutide area. 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 Semaglutide 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. The job
As a Semaglutide CVOT RA Specialist you will be responsible for driving several regulatory tasks with challenging and often overlapping timelines. You will be working closely with Global Regulatory Lead during worldwide submissions. Specifically, you will have a critical responsibility in the submission and approval process, and work with the cross-functional teams toward forming strategies and responding questions to major Health Authorities, and by that, securing progress toward regulatory approvals. You will be involved in critical CVOT strategic discussions in the project, where you will be expected to contribute to regulatory strategies and tactics, be proactive and bold, challenge the discussions and contribute to business-critical decisions. You will, among others, interact with project management, medical and non-clinical specialists, statisticians, and medical writers. You could also contribute to projects for the improvement and maintenance of regulatory processes across the organisation. You will be expected to contribute to developing younger colleagues, sharing your knowledge and experience and contribute to high performance of the regulatory project team.
Qualifications
We expect you have a Master of Science degree in pharmaceutical or life sciences with 6-8 years relevant experience and/or PhD. with 4-5 years of relevant working experience. From your career you have solid experience of handling regulatory documentation for pharmaceutical development within the quality, non-clinical or clinical area. You have experience interacting directly with regulatory authorities on an international scale. You have strong negotiation skills and a sound business understanding. You also know how to set direction, lead, and motivate your team to work for joint objectives. At the same time, you are the team player who assists your colleagues. As a person you are well-organised and have solid problem-solving capabilities, just as you show a winning attitude and never lose your strategic focus. You can keep your spirits high even when under pressure. You are a skilled communicator who can work at any organisational level. Finally, you are comfortable using your fluent written and spoken English.
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/CKD, Rare Endocrine Disorders, and 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 the hiring manager: Emel Mashaki Ceyhan Phone: +45 3448 1007
Deadline
Deadline 5 February 2023.
Please note that applications will be reviewed continuously, and interviews will be planned as soon as a suitable candidate is identified. 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.
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 "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 20.1.2023, 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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