Clinical Reporting competency development specialist within Devices (Denmark, Søborg)

Jobbeskrivelse
Placering
Søborg, Denmark

Jobkategori
Clinical Development

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Are you passionate about clinical process development and eager to drive process innovation and digitalisation? Do you have a profound understanding of device clinical development and an end-to-end mindset?

If so, then you might be our new colleague in the Clinical Reporting Office. The position offers a unique opportunity to work with Device Clinical Processes to leverage best practices and digital innovation to the benefit of our global organisation.

Apply now for this life-changing job opportunity!

The position
In this role, you will act as a SOP responsible for the Medical Device clinical process that covers stand-alone Medical Devices, Software as Medical Devices and Drug-Device combination products. The main process focus will be on regulatory compliance towards submissions for CE-marking in accordance with EU MDR 20217/715, however, SOP and related templates will also accommodate other main markets.

For this role, you will need to be a pragmatic thinker who is able to align compliance and industry standards, and to continuously ensure development of our processes, while implementing digital technologies. You will act as a representative and coordinator in connection with external inspections and internal audits.

In Clinical Reporting we are currently in establishing the device integration across our processes. As such, you will be expected to provide important input to clinical processes across drug and device to facilitate and build integrated processes and a fit-for-purpose approach.

Your main tasks will include:

• Content responsible for a process including authoring Standard Operating Procedures (SOP), guidance and templates
• Setting strategic direction for the process and digital possibilities, and guide the leadership team accordingly
• Securing department, cross-organisational and global knowledge-sharing, and collaboration to ensure operational and efficient processes across therapeutic areas
• Supporting global quality processes for global Clinical Reporting units in connection with inspections and audits, SOP review and impact assessment
• Functioning as Clinical Reporting representative in different internal and external working groups and networks, and assist across Clinical Reporting Office
• Drive competency development in Clinical Reporting.

Qualifications
To be successful in this position, you need to have the following:

• PhD or Master´s degree in science or equivalent
• Extensive and broad experience with device clinical development in the MedTech or pharmaceutical industry; including medical writing, Regulatory Affairs, process ownership or other relevant work
• Experience with a broad range of different medical writing tasks, including structured authoring/content reuse
• Strong experience with regulatory requirements within device clinical development
• A mindset that fosters process innovation and a fit for purpose solutions
• Fluent in written and spoken English

As a person, you are a natural team player, thrive in a complex work environment and bring a can-do-spirit. You are a flexible and change-oriented person with strong analytical skills, who can work independently on larger tasks. Further, it is important for you to be an active contributor to the success of the entire team.

About the department
The position is based in the Clinical Reporting Office in Søborg, Denmark, where we are a team of dedicated colleagues being committed to ensuring competency among our global colleagues who work on our drug and device development projects. Additionally, we have a shared interest in innovation and digitalisation of the processes within Clinical Reporting.

Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific re-search, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

Contact
For further information, please reach out to Director, Klaus Kjær Laigaard, at +45 30793894, or Medical Writing Manager, Stine Ostenfeldt Rasmussen, at +45 30792590.

Deadline
27 November, 2024.

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.

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.