Global Regulatory Specialist (GRL) and Senior RA Professional
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Søborg
Are you able to cut through complexity and drive regulatory strategies for high impact projects? Would you like to work together with experts across multiple functions in a global environment? Do you want to be part of Cardiovascular and Chronic Kidney Disease, an emergent area, where engaged people are committed to bring innovative treatment to patients across the globe?
If yes, apply now for a life-changing career! We are looking for a Global Regulatory Specialist (GRL) and a Senior RA Professional to join our team.
The position
As a Global Regulatory Specialist (GRL) or Senior RA Professional, you will support the development of regulatory strategies and executing various regulatory tasks within cross-functional project teams. This will involve interacting with a diverse array of stakeholders throughout the process.
Your main responsibilities will be focused on:
• Contributing to global regulatory strategies and tactics by providing your specialist knowledge via analysing regulatory opportunities and risks
• Developing regulatory documentation for submission to Health Authorities, e.g. meeting packages, pediatric plans and MAAs/NDAs/BLAs
• Ensuring that the project strategy is implemented in clinical trial protocols and documents supporting clinical trial applications
• Collaborating with project management, medical and non-medical specialists, statisticians, and medical writers
Your contribution in these positions is crucial for delivering cutting-edge solutions that prioritise patients, fostering innovation, and achieving excellence. This necessitates a strong sense of teamwork, collaboration, and expertise, as well as a deep commitment to sharing knowledge among your colleagues. Prepare to be immersed in an environment of talented individuals who embrace cooperation, within a culture that empowers and values humility.
Qualifications
To be a competitive candidate, you should have:
• A master’s degree in life science or similar. Having a PhD would be an advantage
• Solid and hands-on experience working within regulatory, clinical or drug development
• Good pharmaceutical industry knowledge and proficiency in interacting with regulatory authorities on an international scale
• Strong IT/digital skills
• Professional proficiency in English
As a person, you thrive in a fast-paced work environment characterised by ambiguity. You bring a can-do spirit and a healthy sense of humour to your work. You are a flexible and change-oriented person who likes to experiment and sees opportunities rather than limitations in challenging situations.
It is important for you to feel that you are part of a team and an active contributor to the success of the team. You are a skilled communicator who can collaborate as a strategic business partner at any organisational level.
About the department
RA Cardiovascular & Chronic Kidney Disease is responsible for contributing to the development of different products and projects within the cardio-vascular and chronic kidney diseases field working with a pipeline including early and late phase development projects that investigate a variety of different modalities and technologies including monoclonal antibodies and oral administered compounds.
Our department is made up of 16 dedicated and highly engaged employees with diverse background and experience. We are looking for a Global Regulatory Specialist (GRL) and a Senior RA Professional who will focus on early and mid-stage clinical development assets.
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 to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.
Contact
For further information, please contact Poul-Martin Haahr at +45 3075 4082.
Deadline
18 February 2024
To ensure an efficient and fair recruitment process, please refrain from adding a photo to 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.
If yes, apply now for a life-changing career! We are looking for a Global Regulatory Specialist (GRL) and a Senior RA Professional to join our team.
The position
As a Global Regulatory Specialist (GRL) or Senior RA Professional, you will support the development of regulatory strategies and executing various regulatory tasks within cross-functional project teams. This will involve interacting with a diverse array of stakeholders throughout the process.
Your main responsibilities will be focused on:
• Contributing to global regulatory strategies and tactics by providing your specialist knowledge via analysing regulatory opportunities and risks
• Developing regulatory documentation for submission to Health Authorities, e.g. meeting packages, pediatric plans and MAAs/NDAs/BLAs
• Ensuring that the project strategy is implemented in clinical trial protocols and documents supporting clinical trial applications
• Collaborating with project management, medical and non-medical specialists, statisticians, and medical writers
Your contribution in these positions is crucial for delivering cutting-edge solutions that prioritise patients, fostering innovation, and achieving excellence. This necessitates a strong sense of teamwork, collaboration, and expertise, as well as a deep commitment to sharing knowledge among your colleagues. Prepare to be immersed in an environment of talented individuals who embrace cooperation, within a culture that empowers and values humility.
Qualifications
To be a competitive candidate, you should have:
• A master’s degree in life science or similar. Having a PhD would be an advantage
• Solid and hands-on experience working within regulatory, clinical or drug development
• Good pharmaceutical industry knowledge and proficiency in interacting with regulatory authorities on an international scale
• Strong IT/digital skills
• Professional proficiency in English
As a person, you thrive in a fast-paced work environment characterised by ambiguity. You bring a can-do spirit and a healthy sense of humour to your work. You are a flexible and change-oriented person who likes to experiment and sees opportunities rather than limitations in challenging situations.
It is important for you to feel that you are part of a team and an active contributor to the success of the team. You are a skilled communicator who can collaborate as a strategic business partner at any organisational level.
About the department
RA Cardiovascular & Chronic Kidney Disease is responsible for contributing to the development of different products and projects within the cardio-vascular and chronic kidney diseases field working with a pipeline including early and late phase development projects that investigate a variety of different modalities and technologies including monoclonal antibodies and oral administered compounds.
Our department is made up of 16 dedicated and highly engaged employees with diverse background and experience. We are looking for a Global Regulatory Specialist (GRL) and a Senior RA Professional who will focus on early and mid-stage clinical development assets.
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 to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.
Contact
For further information, please contact Poul-Martin Haahr at +45 3075 4082.
Deadline
18 February 2024
To ensure an efficient and fair recruitment process, please refrain from adding a photo to 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.
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 1.2.2024, 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
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