(Senior) Medical Writer
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Søborg
Are you able to combine your scientific knowledge and writing skills? And would you like to be a part of a company which has been a world leader in delivering therapeutics to patients with serious chronic diseases for 100 years? If yes and yes, then we currently have an opening for a Medical Writer or senior Medical Writer with focus on medical devices. Apply now! About the department You will join us in Clinical Reporting, which includes the medical writing function at Novo Nordisk. We are part of Development and anchored in the Submission & Life Cycle Management area. Development is responsible for managing clinical drug and medical device development and regulatory submissions worldwide, from early development phases to market authorisation. For medical devices, main focus is on regulatory submissions for CE-marking in compliance with the EU MDR 2017/715. In Clinical Reporting we are approximately 70 medical writers and clinical publishers, and we pride ourselves on diversity and professionalism. The position
In the role as Medical Writer, you will work as a strategic partner in a dynamic environment within Development to bring ground-breaking treatments and their corresponding delivery solutions to patients worldwide through the planning and preparation of a broad range of regulatory documents. This role will have special focus on regulatory documents for medical devices, including for instance clinical evaluation plans and clinical evaluation reports. Your main task will be:
• Communicating clinical data in a clear and concise manner
• Taking charge of document preparation
• Coordinating activities and work in cross-disciplinary teams The clinical documents you prepare are intended for regulatory authorities and comprise of clinical evaluation plans, clinical evaluation reports, yet with time could also include Q&A interactions with regulatory authorities, preparation of device investigator’s brochures, summary documents and other documents covering interpretation and documentation of clinical data. We cover all clinical device development projects within Novo Nordisk’s product portfolio. As such, we are globally oriented, and the Medical Writer will work in close collaboration with colleagues in other skill areas in Denmark and abroad. Your place of work will be in Søborg, Denmark.
Qualifications Our ideal candidate:
• Has university degree within natural or clinical/medical sciences (preferably an Ph.D)
• Is comfortable with writing and communicating in English at an accomplished professional level
• Possess a genuine interest in scientific communication, and know how to communicate complex information in a clear and concise manner Experience with writing of clinical evaluations for medical devices, software as medical device or drug device combination products will be regarded an asset, so will knowledge about EU-MDR requirements. We are looking for someone who can work both independently, and as part of a cross-functional team, in a changing and dynamic environment with tight deadlines. You should be good at planning, coordinating and managing stakeholders to drive the writing process and to facilitate decision making. You are thorough and structured while being pragmatic and not afraid of challenging the status quo, and in the meantime you have a positive can-do attitude and a good sense of humour. 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 Annerose Berndt - +45 30 79 20 41. Deadline 31 January 2023 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.
In the role as Medical Writer, you will work as a strategic partner in a dynamic environment within Development to bring ground-breaking treatments and their corresponding delivery solutions to patients worldwide through the planning and preparation of a broad range of regulatory documents. This role will have special focus on regulatory documents for medical devices, including for instance clinical evaluation plans and clinical evaluation reports. Your main task will be:
• Communicating clinical data in a clear and concise manner
• Taking charge of document preparation
• Coordinating activities and work in cross-disciplinary teams The clinical documents you prepare are intended for regulatory authorities and comprise of clinical evaluation plans, clinical evaluation reports, yet with time could also include Q&A interactions with regulatory authorities, preparation of device investigator’s brochures, summary documents and other documents covering interpretation and documentation of clinical data. We cover all clinical device development projects within Novo Nordisk’s product portfolio. As such, we are globally oriented, and the Medical Writer will work in close collaboration with colleagues in other skill areas in Denmark and abroad. Your place of work will be in Søborg, Denmark.
Qualifications Our ideal candidate:
• Has university degree within natural or clinical/medical sciences (preferably an Ph.D)
• Is comfortable with writing and communicating in English at an accomplished professional level
• Possess a genuine interest in scientific communication, and know how to communicate complex information in a clear and concise manner Experience with writing of clinical evaluations for medical devices, software as medical device or drug device combination products will be regarded an asset, so will knowledge about EU-MDR requirements. We are looking for someone who can work both independently, and as part of a cross-functional team, in a changing and dynamic environment with tight deadlines. You should be good at planning, coordinating and managing stakeholders to drive the writing process and to facilitate decision making. You are thorough and structured while being pragmatic and not afraid of challenging the status quo, and in the meantime you have a positive can-do attitude and a good sense of humour. 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 Annerose Berndt - +45 30 79 20 41. Deadline 31 January 2023 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 "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 19.1.2023, 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.
- Forretningsudvikler
- Søborg
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