Global Clinical Supply Manager

3 days ago


Copenhagen, Copenhagen, Denmark Genmab AS Full time
About the Position

We are seeking a Global Clinical Supply Manager to join our team in Copenhagen, DK or Princeton, NJ. As a key member of our Global Clinical Drug Supply Operations department, you will be responsible for managing and coordinating drug supply and providing IMP for clinical trials, IST, and Pre-Approval Access Programs.

Key Responsibilities:

  • Manage and coordinate drug supply and provide IMP for clinical trials, IST, and Pre-Approval Access Programs.
  • Manage and coordinate ancillaries, pre-medication, and comparators for clinical trials.
  • Set up English Master Label, manage label translation without vendor and approval of label proofs/designs.
  • Manage set-up of distribution framework through service providers.
  • Define appropriate drug supply activities at CMO necessary for providing drug supplies for clinical trials.
  • Contribute to maintenance of SOPs and Work Instructions in the department.
  • Perform training of other team members.
  • Function as Subject Matter Expert within relevant areas.
  • Responsible for being compliant with Genmab's quality system.

Requirements:

  • At least 3 years' experience in handling clinical drug supply, including setting up label text and handling of ancillaries.
  • Ability to manage stakeholders internally and externally.
  • Experience working with CMO for clinical trial supplies.
  • Training in GDP, GMP, and GCP is a requirement.
  • Experience working with IST and PAA from a Sponsor perspective will be an advantage.
  • Excellent communication skills in English - both oral and written.


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