Senior Medical Writer
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Søborg
We currently have an opening for a Medical Writer or senior Medical Writer with focus on medical devices. This is a fantastic opportunity to combine your scientific knowledge and writing skills in an important role within Novo Nordisk. The company has been a world leader in delivering therapeutics to patients with serious chronic diseases for 100 years. 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.
The position Your main task is to communicate clinical data in a clear and concise manner. To be successful, you must be able: To take charge of document preparation, coordinate 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, Q&A interactions with regulatory authorities. You may also prepare related documents such as device clinical trial protocols, device investigator’s brochures, summary documents and other documents relating to interpretation and documentation of clinical data. We cover all medical 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.
Qualifications You have a university degree within natural or clinical/medical sciences (M.Sc., M.Sc. Pharm or equivalent) and preferably a Ph.D. You are comfortable with writing and communicating in English at an accomplished professional level. You have a genuine interest in scientific communication, and you know how to communicate complex information in a clear and concise manner. Experience with preparing clinical evaluations and trial related documentation for medical devices, software as medical device or drug device combination products will be regarded an asset, so will knowledge about EU-MDR requirements. You can work both independently and as part of a cross-functional team in a changing and dynamic environment with tight deadlines. You are 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. You have a positive can-do attitude and a good sense of humour. 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.
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 Team Lead Stine Ostenfeldt Rasmussen (+45 3079 2590) or Director Annerose Berndt (+45 3079 2041).
Deadline 05 September 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.
The position Your main task is to communicate clinical data in a clear and concise manner. To be successful, you must be able:
Qualifications
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 Team Lead Stine Ostenfeldt Rasmussen (+45 3079 2590) or Director Annerose Berndt (+45 3079 2041).
Deadline 05 September 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 17.8.2023, 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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