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!
Genmab is searching for an energized Senior Associate to be part of Global Clinical Supply, Portfolio & Project Delivery team in Copenhagen within commute distance from our office locations to work according to your 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, 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 opportunities to develop beyond inspection readiness. Working closely with Clinical Supply Managers in the Portfolio & Project Delivery team and colleagues across the department, you will support selected operational tasks and initiatives while gaining broader exposure to clinical trial management. Through collaboration with Clinical Trial Operations and CROs, and hands-on involvement in clinical supply activities, you will further develop your GCP and clinical supply knowledge.
The position is based in Copenhagen.
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 activities related to day-to-day trial management, including coordination, follow-up and preparation of relevant material and documentation.
- Support distribution and logistics, including tasks related to shipment documentation, in alignment with the Drug Supply Managers.
- Build knowledge of especially GCP but also GMP and clinical supply activities within Global Clinical Supply, Portfolio & Project Delivery function
- Participate in maintenance and continuous improvement of procedures, tools and ways of working supporting inspection readiness and clinical supply activities.
- Responsible for being 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 GCP and GMP; 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 GCP/GMP-related activities.
- A team player with demonstrated ability to work effectively cross-functional with internal and external stakeholders.
- Strong communication skills in English - both oral and written.
The TeamYou will be part of a highly competent team focused on end-to-end trial management including planning and maintenance of supplies for clinical trials, working closely with cross-functional stakeholders in both CMC and Clinical Trial Operations.
Together with Global Clinical Supply Manufacturing and Global Clinical Supply Systems, the teams make up the Global Clinical Supply department. We foster a supportive, international, and fast-paced work environment centered on collaboration, excellence, and a can-do attitude to achieve results.
The proposed gross annual/hourly base salary range for this position, in the primary location, based on a full time schedule is:
DKK544.000,00---816.000,00
The final salary offer will depend on several factors, including your skills, qualifications, and experience.
In addition to base salary, this position is eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.
When you join Genmab, you become a part of a culture that supports your physical, financial, social, and emotional well-being. Our benefits include, but are not limited to:
- Pension
- Health insurance and wellness benefits
- Paid time off
- Employee support programs
Further details on eligibility for compensation and benefits based on the role will be provided during the recruitment process.
About 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
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