Competency Development Specialist (Denmark, Søborg)

Novo Nordisk A/S; Søborg; On-site; DKK 743,000 - 1,092,000; Full time

Job summary

Novo Nordisk A/S in Søborg, Denmark, is seeking a Content Responsible for the Medical Device Clinical Evaluation process within the Clinical Reporting Process Excellence department. The role focuses on maintaining SOPs, guidance, templates, and training for stand-alone devices and drug-device combinations, while driving standardisation and digital innovations.

The position collaborates across drug and device processes to enable integrated, fit-for-purpose clinical workflows and to support

Qualifications

• PhD or Master’s degree in science or equivalent required.
• Extensive experience with medical device development or clinical development.
• Experience in medical writing, regulatory affairs, or process ownership is a plus.
• Fluent in written and spoken English.

Responsibilities

• Content Responsible for the Medical Device Clinical Evaluation SOPs, guidance, templates and training.
• Collaborate to simplify and standardise the process and leverage digital opportunities incl. AI use.
• Support quality processes across Clinical Reporting units and assist in inspections and audits.
• Represent Clinical Reporting in working groups to drive competency development.

Skills

Medical device development

Clinical development

Medical writing

Regulatory affairs

Stakeholder management

English proficiency

Education

PhD or Master’s degree in science

Job description

Jobbeskrivelse

Placering
Søborg, Denmark

Jobkategori
Clinical Development

Are you passionate about clinical process development and eager to drive process innovation? 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 Process Excellence department. The position offers a unique opportunity to improve the medical device clinical process to leverage best practices and digital innovation to the benefit of our global organisation.

The position

In this role, you will act as Content Responsible for the Medical Device Clinical Evaluation process, maintaining and improving its Standard Operating Procedures (SOPs), guidance, templates and training for stand-alone medical devices and drug-device combination products. The focus will be on maintaining a well-functioning and compliant process for end-users as well as driving simplifying and standardisation of the process, enabling the implementing digital technologies. You will be part of the Clinical Reporting Process Excellence department and collaborate 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

• Acting as content responsible for the Medical Device Clinical Evaluation process including authoring SOPs, guidance, templates and training.
• In close collaboration with the Process Manager, identifying and implementing improvements to simplify and standardise the process for the end-users and leverage digital opportunities incl. AI use.
• Securing department, cross-organisational knowledge-sharing, and collaborating to ensure operational and efficient processes across therapeutic areas.
• Supporting quality processes across Clinical Reporting units in connection with external and internal inspections and audits, SOP review and impact assessment.
• Assisting across the Clinical Reporting Process Excellence department and functioning as Clinical Reporting representative in working groups and networks. Driving competency development in Clinical Reporting.

Skills and 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 medical device development and/or clinical development in the MedTech or pharmaceutical industry; e.g. medical writing, regulatory affairs, process ownership or other relevant work.
• Broad range of experience within different medical writing tasks, including structured authoring/content reuse. Experience in working with device clinical evaluation or related deliverables and applicable regulatory requirements is considered an advantage.
• Strong drive and proactive stakeholder management skills, and a mindset that fosters process innovation and 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 and a passion to drive change. 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 Søborg, Denmark, where we are a team of dedicated colleagues 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 incl. use of AI in Clinical Reporting Processes.

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.

What we offer

At Novo Nordisk, you’ll join a global healthcare company with a unique culture and strong results. We offer continuous learning, career development, and benefits tailored to your life and career stage.

Salary

Annual Base Salary ranges from 742,600.00 to 1,091,600.00 DKK, corresponding to the level of the position.

The placement within the salary range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge, and relevant experience.

Incentives and Benefits

The salary package may include short-term and/or long-term incentives as well as other employee benefits based on position level, location, functional area and relevant market benchmarks.

Deadline

16th September 26

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.