Clinical Process Innovator — Medical Device Evaluation

Cari; Denmark; Remote; DKK 743,000 - 1,092,000; Full time

Job summary

Novo Nordisk in Søborg, Denmark, seeks a Content Responsible for the Medical Device Clinical Evaluation process. You will maintain SOPs, guidance, templates and training for stand-alone devices and device-drug combos, ensuring a compliant, end-user oriented process and enabling digital innovations.

You will collaborate across Clinical Reporting Process Excellence to drive standardisation, knowledge-sharing, and input to clinical processes across drugs and devices.

Qualifications

• Extensive experience with medical device development and/or clinical development in MedTech or pharma.
• Experience in medical writing, regulatory affairs, or process ownership.
• Experience with medical writing tasks, including structured authoring.
• Strong drive and proactive stakeholder management, fostering process innovation.
• Fluent in written and spoken English.

Responsibilities

• Acting as content responsible for the Medical Device Clinical Evaluation process including authoring SOPs, guidance, templates and training.
• Collaborating to simplify and standardise the process and leverage digital opportunities incl. AI use.
• Securing cross-organisational knowledge-sharing and ensuring efficient processes across therapeutic areas.
• Supporting quality processes across Clinical Reporting units in connection with inspections and audits.
• Assisting the department and representing Clinical Reporting in working groups and networks.

Skills

Medical device development

Clinical development

Medical writing

Regulatory affairs

Process ownership

Structured authoring

Content reuse

English proficiency

Education

PhD or Master's degree in science or equivalent

Job description

Novo Nordisk in Søborg, Denmark, seeks a Content Responsible for the Medical Device Clinical Evaluation process. You will maintain SOPs, guidance, templates and training for stand-alone devices and device-drug combos, ensuring a compliant, end-user oriented process and enabling digital innovations.

You will collaborate across Clinical Reporting Process Excellence to drive standardisation, knowledge-sharing, and input to clinical processes across drugs and devices.