Senior Clinical Supply Associate
4 hours ago
Genmab 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 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.
- Reviewing and approving Master Batch Records generated by our CMOs to ensure compliance with cGMP.
- Maintaining batch overview, including batch release overview, as per alignment with Global Clinical Drug Supply Planning and GMP QA.
- Evaluating temperature excursions reported by our CMOs and clinical sites.
- Performing batch reconciliation and overseeing destruction of product at our CMOs.
- Engaging with stakeholders and collaborating with GMP QA and CMOs/vendors for packaging, labeling, and distribution.
- Supporting trouble shooting and execution of risk mitigation plans.
- Training colleagues in Global Clinical Drug Supply Operations.
- Supporting inspection and audit preparation and execution.
- Participating in maintenance of SOPs.
- Ensuring 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 setting up 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 high pace while having fun and focus on one team spirit both within and outside the team and department. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
How to ApplyIf you are a motivated and experienced professional looking for a new challenge, please upload your CV and cover letter, including your motivation for this position. We screen candidates on a continuous basis and call in for interviews.
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