Are you passionate about medical devices and are you able to set direction and lead product innovation from a medical writing perspective? If yes, you might be the one we are looking for as experienced Device Medical Writer to join our team in Søborg, where you will be driving clinical documentation for medical devices and make significant impact! 

The position
We have an opening for a Senior or Specialist Medical Writer role 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 this role, 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. In this role your main tasks are to drive progress of clinical submission documents and communicate clinical data in a clear and concise manner.  In this role, you will:

Act as project or product medical writer, supporting peer medical writers, managing incoming tasks, and tracking progress to ensure deadlines are met. Manage stakeholder relationships to drive the writing process and facilitate decision-making. Work independently and as part of a cross-functional team in a dynamic environment with tight deadlines, Drive the document preparation and coordination – for clinical documents for regulatory authorities, including clinical evaluation plans, clinical evaluation reports and Q&A interactions with health authorities. You will likely also prepare related documents such as meeting packages, 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.  Have a genuine interest in scientific communication, and you know how to communicate complex information in a clear and concise manner – for this you must be thorough and structured while being pragmatic and not afraid of challenging the status quo. Have a can-do attitude. 

As such, we are globally oriented, and you will work in close collaboration with colleagues in other skill areas in Denmark and abroad. In addition to your own medical writing tasks, you will mentor and train other medical writers. You might as well work to develop and improve our internal processes and promote the sharing of better practices across areas.

 

We offer a modern work environment with flexible working and possibility to work from home some days, while your place of work will be anchored in Søborg, Denmark.

Qualifications
To be considered for this position you should:

Hold a university degree within natural or clinical/medical sciences (M.Sc., M.Sc. Pharm or equivalent) and preferably a Ph.D. with a couple of years’ experience or 3-5 years of relevant experience.  Be a clear communicator both in written and spoken English at an accomplished professional level. Have experience with preparing clinical evaluations and trial related documentation for medical devices, software as medical device, drug device combination products or in-vitro diagnostic products.  Have some knowledge about EU-MDR requirements whereas requirements for other big markets will be regarded an asset.

 

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 Regulatory, Quality & Clinical Reporting. Development is responsible for managing clinical drug and medical device development and regulatory submissions worldwide, from early development phases to market authorisation and keeping products on the market. For medical devices, main focus is on regulatory submissions for CE-marking in compliance with the EU MDR 2017/715 and FDA requirements.

Working at Novo Nordisk
Novo Nordisk is driving change to defeat diabetes and other serious chronic conditions. We use our skills, dedication and ambition to help change lives for the better for patients around the world. We strive for excellence, and for always keeping a positive and collaborative atmosphere in our daily work. 

Contact
For further information please contact Manager Stine Ostenfeldt Rasmussen (+45 3079 2590).

 

Deadline
03 March 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 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.