Novo Nordisk

Conduct in-depth research and analysis of rare disease markets, including competitive landscape, market dynamics, and emerging trends. Develop and maintain a comprehensive understanding of the rare disease market, including key players, product portfolios, and future opportunities. Collaborate with cross-functional teams to gather and synthesise relevant data and insights to support strategic decision-making.

Responsible for identifying and driving improvement projects within Deviations, CR handling, and other relevant processes, together with the process manager. Derive KPIs for the QMS and measure performance and put in place improvements.

The CRA is as such responsible for recruitment at site level. The CRA thereby delivers results that have a direct impact on the successful completion of the clinical programme.

As Regulatory Professional, the candidate will be responsible for making the timely submissions to the Health Authorities worldwide. The candidate is expected to establish and maintain the CMC part of the core regulatory file. Further responsibilities include Life Cycle Management.

Communicate clinical data clearly and concisely, contributing to process improvements, knowledge sharing, and skill building. Mentor and train other medical writers as needed, while maintaining good relationships with stakeholders and colleagues.

As Regulatory Professional II, the candidate will be responsible for making the timely submissions to the Health Authorities worldwide.

You will be a member of a newly established virtual team - EU Submission Hub with colleagues in Denmark, Portugal, Poland and Bangalore focusing on clinical trial submissions in EU. EU Submission Hub is part of Submission Management department, who is responsible for electronic submissions to Health Authorities including New Drug Applications and Life Cycle submissions.

As a CDC Trial Manager is the main accountable person in making sure that deliverables are met as per project timelines, within budget and complying with Protocol, country regulatory requirements, Helsinki Declaration, GCP, Good Clinical Practice, and NN SOPs Standard Operating Procedures. bachelor degree in life science, pharmacy, or nursing qualification or equivalent.