Senior Medical Writer (Denmark, Søborg)

Jobbeskrivelse
Placering
Søborg, Denmark

Jobkategori
Clinical Development

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We have an opening for an experienced Medical Writer with focus on medical devices.

Do you want to combine your scientific knowledge and writing skills in an important role within Novo Nordisk? Then this is a fantastic opportunity for you to work for the company that has been a world leader in delivering therapeutics to patients with serious chronic diseases for 100 years.

As a Senior 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.

Apply now for a life-changing career!

The position
In the role of Senior Medical Writer your main task is to communicate clinical data in a clear and concise manner. Other responsibilities will include:

• Stakeholder management to drive the writing process and facilitate decision-making - you can work both independently and as part of a cross-functional team in a changing and dynamic environment with tight deadlines.

• Take charge of document preparation and coordination - the clinical documents you prepare are intended for regulatory authorities and comprise of clinical evaluation plans, clinical evaluation reports, post market clinical follow-up plans, post market clinical follow-up reports and Q&A interactions with health authorities.

• Prepare related documents such as device clinical investigation protocols, device investigator’s brochures, summary documents, and other documents relating to the interpretation and documentation of clinical data. We cover all medical device development projects within Novo Nordisk’s product portfolio.

• Act as project or product medical writer which includes support to peer medical writers, keeping an overview of incoming tasks and track of progress across deliverables to ensure that deadlines are met.

As such, we are globally oriented, and as a Senior Medical Writer 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.

Qualifications
As a person, you have a genuine interest in scientific communication, and you know how to communicate complex information clearly and concisely – for this, you must be thorough and structured while being pragmatic and not afraid of challenging the status quo, with a can-do attitude.

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. and/or 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 devices, 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 authorization, and keeping products on the market. For medical devices, the main focus is on regulatory submissions for CE-marking in compliance with the EU MDR 2017/715 yet also supports other main markets.

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.

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

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

Deadline
24 November 2024.

You do not need to attach a cover letter to your application, yet 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 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.