Supply Chain Professional
2 days ago
We're seeking a seasoned Clinical Drug Supply Manager to join our team in Copenhagen, Denmark or Princeton, New Jersey.
This position requires a strong background in cGMP and a focus on delivering high-quality results.
About the Job
- Manage the coordination of drug supply and provide IMPs for clinical trials, IST, and PAA programs.
- Develop and implement English Master Labels, manage label translations without vendor involvement, and approve label designs.
- Establish and maintain distribution frameworks through service providers.
- Define necessary drug supply activities at CMOs.
- Contribute to the development and maintenance of SOPs and Work Instructions.
- Provide training to colleagues.
- Function as a subject matter expert within specific areas.
- Ensure compliance with Genmab's quality system.
Key Requirements
- Minimum three years of experience in clinical drug supply management, including setup and management of label text and ancillaries.
- Proven ability to manage stakeholders internally and externally.
- Experience working with CMOs for clinical trial supplies.
- Training in GDP, GMP, and GCP is mandatory.
- Advantageous: previous experience working with IST and PAA from a sponsor perspective.
- Strong communication skills in English, both spoken and written.
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