Clinical Reporting competency development specialist within Devices

at  Novo Nordisk

Clinical Reporting competency development specialist within Devices
Category: Clinical Development
Location:Søborg, Capital Region of Denmark, DK
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!

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.

• 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