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 RoleGenmab 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.ResponsibilitiesSupport 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 Genmabs quality system.RequirementsMinimum a bachelor’s degree or equivalent.2-3 years experience working with documentation, quality or compliance activities in the pharmaceutical, biotech, clinical research or another regulated environment is an advantage.IRT or systems knowledge strongly preferredKnowledge and understanding of GMP and GCP; experience with inspection or audit readiness is an advantage.Strong interest in documentation, quality and compliance, with a structured and detail-oriented approach to your work.Ability to coordinate activities, maintain structure and follow up on actions involving multiple stakeholders.Ability to work successfully under pressure in a fast-paced environment and with tight timelines, including during inspections.Ability to be proactive, enthusiastic, curious and goal orientated, with a willingness to learn new GMP-related activities.A team player with demonstrated ability to work effectively with internal and external stakeholders, including CMOs and vendors.Strong communication skills in English - both oral and written.The TeamYou will be part of a highly competent team focused on GMP, GCP, and computerized system management with a strong focus on quality, inspection readiness and successful collaboration with our internal stakeholders and vendors.Together with Global Clinical Supply Portfolio & Project Delivery and Global Clinical Supply Manufacturing, the teams make up the Global Clinical Supply department.We have an international and informal working environment with a high pace, strong one-team spirit and close collaboration across functions.ApplicationHas this sparked your interest? Then we encourage you to upload your CV and cover letter including your motivation for this position. We screen candidates on a continuous basis and call in for interviews.Fully remote applicants will not be considered, so please indicate if you are willing to relocate if you’re not currently living in commute distance.For US based candidates, the proposed salary band for this position is as follows:$82,480.00---$123,720.00The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:401(k) Plan: 100% match on the first 6% of contributionsHealth Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insuranceVoluntary Plans: Critical illness, accident, and hospital indemnity insuranceTime Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leaveSupport Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being supportAdditional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses Further details on eligibility for compensation and benefits based on role will be provided during the recruitment processAbout GenmabGenmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.Job SummaryJob number: R17997Profession: Development