Regulatory Professional – Clinical Trial Submissions, EU
Novo Nordisk
full-time
Posted on:
Location Type: Hybrid
Location: Søborg • Denmark
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Tech Stack
About the role
- Play a crucial role in driving, coordinating, and actively following up on multiple tasks with challenging timelines.
- Working on process optimisation for CTA submissions within a team and stakeholders from other teams.
- 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.
- Ensuring timely submissions in CTIS and contributing to project team decisions.
- Shaping the future setup of new processes for submitting Clinical Trial Applications (CTAs).
- Collaborating with different IT platforms, such as Veeva Vault RIM and Vault Clinical (COSMOS).
Requirements
- Master’s degree in life science or relevant field.
- + 5 years of experience in working with clinical trials and submissions.
- EU Clinical Trial Regulation 536/2024 (EU CTR) understanding and experience.
- Experience in working with Vault RIM and Vault Clinical (Veeva platforms), it’s a plus.
- Experience working with Clinical Trial Information System (CTIS) (how to upload documents and knowledge of full CTIS structure for Part I and part II) – is a big advantage.
- Fluency in written and spoken English.
- Experience with improvement of work flows/optimisation projects.
Benefits
- Opportunities to learn and develop
- Inclusive recruitment process and equality of opportunity for all job applicants
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial application submissionsprocess optimisationdocument managementdata accuracyworkflow improvementCTIS structure knowledgeEU Clinical Trial Regulation 536/2024clinical trial submissions experiencestakeholder coordinationinformation request management
Soft Skills
communicationcollaborationorganizational skillstime managementproblem-solvingteam coordinationattention to detailadaptabilityleadershipinitiative
Certifications
Master’s degree in life scienceclinical trial certificationregulatory affairs certificationproject management certificationGCP certificationclinical research certificationdata management certificationquality assurance certificationrisk management certificationmedical writing certification