EU Submission Lead for Clinical Trials
2 weeks ago
The position
As an EU Submission Lead for Clinical Trials, you will play a crucial role in driving, coordinating, and actively following up on multiple tasks with challenging timelines. Your responsibilities will include: Working closely with various submission teams across the organization and all countries in Europe Managing initial clinical trial application submissions in the EU according to the Clinical Trial Regulation (EU CTR) and all changes during the life cycle of clinical trials Maintaining documents in the Clinical Trial Information System (CTIS) and ensuring accurate data about clinical trials Coordinating responses for requests for information from Health Authorities and Ethics Committees, and ensuring timely submissions in CTIS, and contributing to project team decisions Shaping the future setup of new processes for submitting Clinical Trial Applications (CTAs) in the EU Collaborating with different IT platforms, such as Veeva Vault RIM and Vault Clinical (COSMOS) This position is based in Denmark, within our office located in Søborg. Qualifications As a person, you bring exceptional qualities to the team, including strong organizational skills, adept problem-solving abilities, and excellent communication skills. Your positive outlook and ability to inspire others under pressure contribute to effective collaboration across all levels of the organization. With a curious mindset and a passion for learning, you eagerly embrace growth opportunities. Additionally, you thrive in virtual multicultural environments, demonstrating genuine enthusiasm for collaborating with diverse online teams. Other qualifications include Bachelor´s degree, master’s degree, or Ph.D. in science, pharmaceutical or health science At least 2 years of experience in regulatory affairs or clinical trials Vault RIM and Vault Clinical (Veeva platforms) knowledge would be an advantage Fluent written and spoken English About the department 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. Working at Novo Nordisk At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.-
EU Submission Lead for Clinical Trials
2 weeks ago
Søborg, Denmark Novo Nordisk AS Full timeAre you ready to play a crucial role in driving and coordinating multiple tasks with challenging timelines? Do you have experience in regulatory affairs or clinical trials? We are looking for a motivated EU Submission Lead for Clinical Trials to join our newly established virtual team in Novo Nordisk. If you are passionate about making a difference in the...
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