EU Submission Lead for Clinical Trials – RA – Novo Nordisk – Søborg

   Do you have experience working with regulatory clinical trial submissions? Are you able to take the lead and drive regulatory responses to Health Authorities and Ethics Committees and ensuring timely submissions? Then you might be our new EU Submission Lead for Clinical Trials.Join Regulatory Affairs (RA) and become part of an exciting environment where engaged people are committed to gain approval of Novo Nordisk’s Clinical Trials (CTs) across the globe.  The PositionAs EU Submission Lead you will be required to drive, coordinate and actively follow-up on several tasks with challenging and often overlapping timelines. In this role you will work closely with various submission teams across the organisation and all countries in Europe. You will be part of initial clinical trial application submissions in EU and all changes during life cycle of clinical trials. Not only you will be responsible for maintaining documents in Clinical Trial Information System (CTIS), but also data about clinical trials. Furthermore, you will play a key role in coordinating responses for request for information from Health Authorities and Ethics Committees and ensuring timely submissions in CTIS. We expect you are proactive, able to challenge the discussions and contribute to project team decisions. It is crucial that you are flexible and easily adapt to a changing job environment. As new processes for submitting CTAs (Clinical Trial Application) in EU are still under development, you will be involved in shaping the future set up while at same time providing stability for new clinical trial submissions under EU Clinical Trial regulation via CTIS.  Furthermore, you enjoy working with different IT platforms, like Veeva Vault RIM and Vault Clinical (COSMOS).  QualificationsWe expect you to have:Bachelor’s degree or a Master’s degree on Biochemistry, Pharmaceutical science, Chemical engineering or a similar university degree.Preferably minimum 3 years regulatory affairs or clinical trial experience would be a benefit.Ability to establish and maintain effective working relationships with co-workers and stakeholders.As a person you are a team player, well organised, structured and have solid problem-solving capabilities. You can keep your spirits high even when under pressure. You are detail oriented and a skilled communicator who can cooperate at any organisational level. Finally, you are comfortable using your fluent written and spoken English. About the departmentYou will be a member of a new and growing hybrid EU Submission team with colleagues in Denmark and Bangalore focusing on clinical trial submissions in EU. You will join CTA management department, which already is consisting of 9 dedicated and highly engaged employees. CTA management support clinical trial submissions globally and plays a key role in creation on submission packages.  Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting and challenging place to work.  Working at Novo NordiskAt Novo Nordisk, we use our skills, dedication, and ambition to help people with various diseases. We offer the chance to be part of a truly global and highly diverse workplace, where passion and engagement are met with opportunities for professional and personal development. ContactFor further information, please contact Fi With Gjessø, +45-30777812.  Deadline29. June 2022 Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.  At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing. 

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