Clinical Supply Chain Manager
3 days ago
We are seeking an experienced Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team in Copenhagen, DK or Princeton, NJ.
The ideal candidate will have extensive knowledge of cGMP and a focus on the level of quality in work performed. They will manage outsourcing of packaging, labeling, and distribution of clinical trial supplies for early as well as late-stage Genmab clinical trials.
The Clinical Drug Supply Manager will work closely with GMP QA and our CMOs to ensure timely packaging and labeling for our clinical trials, as well as IST and PAA for patients with cancer and other serious diseases.
About the Role
- Manage and coordinate drug supply and provide IMP for clinical trials, IST, and Pre-Approval Access Programs.
- 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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