Device Clinical Process Excellence Specialist

Novo Nordisk A/S; Denmark; Remote; 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. You will maintain SOPs, guidance, templates and training for stand-alone medical devices and drug-device combinations, driving a compliant and user-friendly process and enabling digital technologies.

The role sits in the Clinical Reporting Process Excellence department, collaborating to integrate clinical processes across drug and device lines, and contributing to global

Qualifications

• PhD or Master's degree in science or equivalent.
• Experience with medical device development and/or clinical development in MedTech or pharmaceutical industry.
• Experience with medical writing, regulatory affairs, process ownership or related work.
• Fluent in written and spoken English.

Responsibilities

• Act as content responsible for the Medical Device Clinical Evaluation process including authoring SOPs, guidance, templates and training.
• Identify and implement improvements to simplify and standardise the process and leverage digital opportunities incl. AI use.
• Secure department knowledge-sharing and ensure efficient processes across therapeutic areas.
• Support quality processes across Clinical Reporting units during inspections and audits.
• Act as Clinical Reporting representative in working groups and drive competency development.

Skills

English proficiency

Process improvement

Stakeholder management

Clinical process development

Education

PhD or Master's degree in science

Job description

Novo Nordisk A/S in Søborg, Denmark, is seeking a Content Responsible for the Medical Device Clinical Evaluation process. You will maintain SOPs, guidance, templates and training for stand-alone medical devices and drug-device combinations, driving a compliant and user-friendly process and enabling digital technologies.

The role sits in the Clinical Reporting Process Excellence department, collaborating to integrate clinical processes across drug and device lines, and contributing to global