Regulatory Documentation Specialist

2 days ago


Odense, Odense Kommune, Denmark Novo Nordisk AS Full time

Novo Nordisk A/S is significantly increasing its manufacturing capacity to serve more patients in the coming years. Our operation readiness team requires a dedicated Regulatory Documentation Specialist to ensure our products meet the highest standards. We are looking for an experienced Technical Writer who can work with great independence and a strong desire to improve and optimize their work area.

The Position

  • Develop training plans, standard operating procedures, job instructions, risk management plans, and regulatory impact assessments.
  • Support and coordinate the validation of processes in projects and small changes, ensuring compliance with regulations.
  • Ensure documentation meets regulatory requirements, with a focus on timely approval of internal documents and procedural changes.
  • Independently solve daily tasks, proactively collaborating with quality teams and across departments to achieve optimal solutions.
  • Contribute to process improvements, participate in audits and inspections, and actively apply cLEAN tools for continuous improvement.

Qualifications

  • MSc/BSc education in natural or technical sciences, such as mechanical or manufacturing engineering, or a related field (a minimum of technical education required).
  • Experience in the pharmaceutical or biotechnology industry, and knowledge within a production area.
  • Familiarity with electronic records.
  • Strong organizational and project management skills.
  • Good communication skills and the ability to create transparency for colleagues within the team.


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