Senior Clinical Supply Associate
4 weeks ago
We are seeking a highly skilled Senior Clinical Drug Supply Associate to join our Global Clinical Drug Supply Operations team in Copenhagen or Princeton. As a key member of our team, you will play a central role in the execution of tasks related to packaging, labeling, and distribution of clinical trial supplies for early and late-stage clinical trials, IST, and PAA for patients with cancer and other serious diseases.
Key Responsibilities- Creation and review of clinical labels from English Master Label to translation and proofreading.
- Ordering products via CMOs and sourcing vendors for use in clinical trials as per relevant legislation.
- Review and approval of Master Batch Records generated by our CMOs to ensure compliance with cGMP.
- Maintenance of batch overview, including batch release overview, as per alignment with Global Clinical Drug Supply Planning and GMP QA.
- Evaluation of temperature excursions reported by our CMOs and clinical sites.
- Batch reconciliation and oversight of destruction of product at our CMOs.
- Stakeholder engagement and collaboration related to drug supply operations, including GMP QA and CMOs/vendors for packaging, labeling, and distribution.
- Support for trouble shooting and execution of risk mitigation plans.
- Training of colleagues in Global Clinical Drug Supply Operations.
- Support for inspection and audit preparation and execution.
- Participation in maintenance of SOPs.
- Compliance with Genmab's quality system.
- Minimum of a Bachelor's degree or equivalent.
- Advantage with 2+ years' experience in handling clinical drug supply, including setup of label text, handling of ancillaries, distribution with cold chain management from CMO, Biotech or Pharma companies.
- Experience in working with CMO for clinical trial supplies.
- Knowledge and understanding of GMP, GDP, and GCP.
- Proven experience working in teams.
- Ability to work successfully under pressure in a fast-paced environment and with tight timelines.
- Ability to be proactive, enthusiastic, and goal-oriented.
- A team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders to support the execution of tasks.
- Strong communication skills in English - both oral and written.
As a Senior Clinical Drug Supply Associate at Genmab, you will have the opportunity to work in a dynamic and innovative environment with a team of highly skilled professionals. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
Genmab is an equal opportunities employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and supportive work environment that values diversity and promotes equal opportunities for all employees.
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Senior Clinical Supply Associate
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab is seeking a highly skilled Senior Clinical Drug Supply Associate to join our Global Clinical Drug Supply Operations team in Copenhagen or Princeton. As a key member of our team, you will play a crucial role in the execution of tasks related to packaging, labeling, and distribution of clinical trial supplies for early and late-stage...
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