At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
The role
Genmab is looking for an additional System Compliance Manager for our enterprise electronic document management system (EDMS) – GenDocs, covering the clinical development, regulatory affairs, CMC, and QA areas in R&D.
GenDocs is a global IT system in Genmab based on the Veeva Vault cloud platform and it supports daily operations in our dynamic and expanding R&D organization.
Digital Systems Management is a global IT application team located in US and in Europe which supports, develops, and innovates IT systems, primarily Veeva Vaults, and processes in R&D. We do this by working closely together with the line of business departments, understanding, and bridging their business needs to optimized systems.
As a System Compliance Manager in Digital Systems Management, you will be improving and developing the IT compliance of the GenDocs system and the associated business and administration processes around the system.
This will be done in close collaboration with the rest of the team by for example updating system related documentation, conducting periodic reviews, investigating issues or new requirements, improving, and updating processes for operating and maintaining the system, participating in new Veeva projects as Validation Lead/SME, participating as Migration Lead for migration projects, preparing and participating in audits and inspections of the GenDocs system, etc.
A part of the role will also be dedicated to system management work, for example configuring, implementing, and validating new system features, to ensure your knowledge and skills of the system are continuously maintained.
This is a great opportunity for you to work and develop your competences and skills within an IT system team and get first-hand experience of how a biotech company operates. The position also involves communication with external vendors, and with end users in line of business through projects, network groups, daily tasks etc.
Responsibilities
Requirements
Moreover, you meet the following personal requirements:
About You
Locations
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.
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