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Senior Associate, Global Clinical Drug Supply Execution

Genmab

Genmab seeks a Senior Associate to support inspection readiness across late-stage clinical trials in Copenhagen. The role involves organizing clinical supply documentation, performing compliance checks, and participating in GMP and GCP inspections while developing broader clinical trial management knowledge.

Responsibilities

  • Collect, organize and maintain clinical supply documentation for inspection readiness across late-stage trials
  • Perform completeness and compliance checks of trial documentation against procedures and expectations
  • Support back-office activities during inspections, including document retrieval and request coordination
  • Assist with preparation for mock inspections, audits and health authority inspections
  • Support day-to-day trial management, distribution logistics, and procedure improvement initiatives

Requirements

  • Bachelor's degree or equivalent qualification
  • Experience with documentation, quality, or compliance in pharmaceutical, biotech, or regulated environment
  • Knowledge of GCP and GMP principles; inspection or audit readiness experience preferred
  • Detail-oriented approach with strong interest in documentation and quality
  • Ability to coordinate activities across multiple stakeholders and manage competing priorities
  • Capability to perform effectively under pressure in fast-paced settings
Ledig stilling opslået Indrykket for 4 dage siden
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