Global Clinical Supply Manager
3 days ago
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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