Clinical Supply Chain Manager
2 weeks ago
The Clinical Drug Supply Manager role at Genmab involves overseeing the outsourcing of packaging, labelling, and distribution of clinical trial supplies for early and late-stage trials.
The successful candidate will be responsible for managing stakeholders, setting up label text, and coordinating ancillaries, pre-medication, and comparators for clinical trials.
Responsibilities:
- 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 with out 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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