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Regulatory Affairs Manager Clinical Trials

2 weeks ago

Copenhagen, Copenhagen, Denmark Genmab AS Full time

Job Overview

We are seeking a detail-oriented and organized individual to join our Clinical Trial Disclosure & Transparency team at Genmab A/S. As a Regulatory Affairs Manager Clinical Trials, you will be responsible for ensuring high-quality disclosure of clinical trial information and overseeing the relationship with our disclosure vendor(s) to ensure efficiency and compliance.

Your Key Responsibilities

  • Manage public disclosure of clinical trial protocols, results, and document redaction.
  • Develop and maintain timelines for protocol registration and results disclosure on platforms such as ClinicalTrials.gov and EU CTIS.
  • Collaborate with cross-functional teams to implement new transparency requirements.
  • Oversee relationships with disclosure vendors to ensure efficiency and compliance.

Requirements

  • Previous experience with clinical trial disclosure.
  • Bachelor's degree minimum.
  • 1-3+ years of pharmaceutical industry experience with a good understanding of clinical development.
  • Excellent written and verbal communication skills.

About Us

Genmab is an international biotechnology company with a strong commitment to innovation and collaboration.