MedTech Clinical Evaluation Content Lead

Biopharma Careers; Søborg; On-site; DKK 743,000 - 1,092,000; Full time

Job summary

Novo Nordisk seeks a Content Responsible for the Medical Device Clinical Evaluation process, owning SOPs, templates and training while driving standardisation and digital opportunities including AI. You’ll collaborate with the Process Manager to ensure end-user efficiency and cross‑functional knowledge sharing across drug and device areas.

You will be part of the Clinical Reporting Process Excellence department based in Søborg, contributing to inspections, audits and continuous competency

Qualifications

• PhD or Master’s degree in science or equivalent.
• Extensive experience with medical device development and/or clinical development in MedTech or pharmaceutical industry.
• Broad experience in medical writing, regulatory affairs or process ownership.
• Experience with device clinical evaluation or related deliverables and regulatory requirements is a plus.
• Strong drive, stakeholder management and a mindset for process innovation.

Responsibilities

• Act as content responsible for the Medical Device Clinical Evaluation process, including SOPs, guidance, templates and training.
• Collaborate to identify improvements to simplify and standardise the process and leverage digital opportunities incl. AI.
• Ensure cross‑functional knowledge sharing and efficient processes across therapeutic areas.
• Support quality processes across Clinical Reporting units during inspections, audits and SOP reviews.
• Serve as Clinical Reporting representative in working groups and networks; drive competency development.

Skills

Medical device development

Clinical development

Regulatory affairs

Process ownership

Stakeholder management

Education

PhD or Master’s degree in science

Job description

Novo Nordisk seeks a Content Responsible for the Medical Device Clinical Evaluation process, owning SOPs, templates and training while driving standardisation and digital opportunities including AI. You’ll collaborate with the Process Manager to ensure end-user efficiency and cross‑functional knowledge sharing across drug and device areas.

You will be part of the Clinical Reporting Process Excellence department based in Søborg, contributing to inspections, audits and continuous competency