Senior Associate, Global Clinical Drug Supply Systems

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! The Role Genmab is searching for an energized Senior Associate to be part of Global Clinical Supply Systems in Plainsboro, NJ within commute distance to our office location to work according to an in-office or hybrid work arrangement. With an impressive pipeline and many ongoing clinical trials, you will have a central role in supporting inspection readiness across our late-stage clinical development portfolio. Your work will help ensure that documentation is complete, compliant and readily available to support the successful execution of business-critical GMP and GCP inspections. You will support inspection readiness activities within Global Clinical Supply Systems, collecting, organizing and performing completeness and compliance checks of trial-specific documentation. During inspections, you will participate in back-office activities and help ensure timely retrieval and follow-up of requested information. The role also offers an opportunity to develop beyond inspection readiness. You will work closely with the Head of Global Clinical Supply Systems along with other team members to support selected functional initiatives, providing exposure to broader activities across the organization and vendor network. In parallel, you will have the opportunity to build your GMP, GCP, and clinical supply knowledge by learning and supporting selected operational activities. The position reports to the Director, Head of Global Clinical Supply Systems or Associate Director, IRT Management based in Plainsboro, NJ. Responsibilities Support inspection readiness across late-stage clinical trials by collecting, organizing and maintaining relevant clinical supply documentation. Perform completeness and compliance checks of trial-specific documentation against applicable procedures and inspection-readiness expectations. Participate in back-office activities during GMP and GCP inspections, including document retrieval, request coordination and tracking of responses and follow-up items. Support preparation for mock inspections, audits and health authority inspections, including compilation and review of supporting documentation for completeness and readiness. Support the Head of Global Clinical Supply Systems with selected functional initiatives and tasks across the organization. Support activities related to our IRT/RTSM vendor network, including coordination, follow-up and preparation of relevant material and documentation. Build knowledge of GMP, GCP, and clinical supply activities within Global Clinical Supply. Participate in maintenance and continuous improvement of procedures, tools and ways of working supporting inspection readiness and clinical supply activities. Responsible to be compliant with Genmab´s quality system. Requirements Minimum a bachelor’s degree or equivalent. Some experience working with documentation, quality or compliance activities in the pharmaceutical, biotech, clinical research or another regulated environment is an advantage. Knowledge and understanding of GMP and GCP; experience with in…

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