Novo Nordisk

Maintain regular communication with internal stakeholders to gather business requirements, support strategic pricing projects, and ensure customer satisfaction through quality support

Support affiliates in updating local requirements based on regulatory agencies guidance and input from affiliates, distributors. Manage working relationships with key stakeholders. Ensure compliance with regulatory requirements and provide strategic product direction to teams.

As an Associate Global Scientific Advisor, you will Provide timely, accurate and credible scientific and medical input for a variety of projects pertaining to scientific communication around Novo Nordisk’s products. Collaborate closely and communicate effectively with various cross-functional stakeholders including colleagues from the US affiliate, global medical affairs, and other functional areas. Engage in dialogue with Key Opinion Leaders (KOLs) in different settings with focus on medical and scientific information. Prepare presentations for Novo Nordisk standalone events and international medical congresses.

Performing medical writing tasks for trial and/or non-trial activities within clinical reporting including but not limited to preparation of Protocols, Clinical Trial Reports CTRs, Non-interventional study reports NSRs, Layperson Summary LPS, Investigator Brochure and Regulatory response documents. PhD, MSc, MPharm, PharmD

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.