Manager of Clinical Drug Distribution
15 hours ago
We're looking for a skilled Clinical Drug Supply Manager to join our team in Copenhagen, Denmark or Princeton, New Jersey.
This role involves managing clinical trial supplies, collaborating with CMOs, and ensuring compliance with quality standards.
About the Team
- You'll be part of a highly competent team focused on packaging and labeling of supplies for clinical trials.
- You'll work closely with the Global Clinical Drug Supply Planning team and our CMOs.
Responsibilities
- Coordinate drug supply and provide Investigational Medicinal Products (IMPs) for clinical trials, Investigator-Sponsored Trials (IST), and Pre-Approval Access (PAA) programs.
- Establish English Master Labels, oversee label translations, and approve label designs without vendor involvement.
- Set up distribution frameworks through service providers.
- Determine necessary drug supply activities at Contract Manufacturing Organizations (CMOs).
- Collaborate on Standard Operating Procedures (SOPs) and Work Instructions in the department.
- Train colleagues on relevant topics.
- Serve as a subject matter expert within specific areas.
- Maintain Genmab's quality system compliance.
What We're Looking For
- A minimum of three years of experience in clinical drug supply management, including setup and management of label text and ancillaries.
- Effective stakeholder management skills, both internal and external.
- Experience working with CMOs for clinical trial supplies.
- Training in Good Distribution Practice (GDP), Good Manufacturing Practice (GMP), and Good Clinical Practice (GCP) is required.
- Previous experience working with IST and PAA from a sponsor perspective would be advantageous.
- Exceptional communication skills in English, both spoken and written.
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