Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy.
Post : Regulatory Professional I - Clinical trial Submission
Department : EU Submissions Hub
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.
Job Description
As Regulatory Professional, 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 (uploading and QC) 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
• 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).
Candidate Profile
• Bachelor´s degree, master’s degree, or Ph.D. in science, pharmaceutical or health science
• At least few years of experience in regulatory affairs or clinical trials
• Fluent written and spoken English.
• Vault RIM and Vault Clinical (Veeva platforms) knowledge would be an advantage.
On personal level :
• Strong team player
• Well organised, structured, and detailed oriented
• Have solid problem-solving capabilities
• Can keep your spirits high even when under pressure
• Skilled communicator who can cooperate at any organisational level
• Curios and like learning new things
• You love data and working in systems
• Enjoy working with people online and want to be part of virtual multi-cultural team.
Additional Information
Experience : Few years of experience
Qualification : Ph.D, M.Pharm, B.Pharm, M.Sc
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Clinical trial Submission
End Date : 9th May 2024
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