Novo Nordisk

Regulatory Professional – Clinical Trial Submissions, EU

Novo Nordisk

full-time

Posted on:

Location Type: Hybrid

Location: Warsaw • Poland

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Tech Stack

Vault

About the role

  • 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 workflows/optimisation projects.
Benefits
  • Opportunities to learn and develop
  • Health insurance
  • Retirement plans
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 lifecycle managementinformation request coordinationsubmission timelines management
Soft Skills
collaborationcommunicationstakeholder managementteamworkorganizational skillsproblem-solvingattention to detailadaptabilityleadershipproject decision contribution
Certifications
Master’s degree in life science or relevant field