Enterprise Systems Optimization Specialist

1 month ago


Copenhagen, Copenhagen, Denmark Genmab Full time

At Genmab, we're driven by a commitment to transforming the lives of patients through innovative cancer treatment.

We're seeking an experienced Enterprise Systems Optimization Specialist to join our team in maintaining, developing, and operating our enterprise electronic document management system (EDMS), GenDocs. This role will cover the clinical development, regulatory affairs, CMC, and QA areas in R&D.

The EDMS is a global IT system based on the Veeva Vault cloud platform, supporting daily operations in our dynamic and expanding R&D organization. As a key member of our Digital Systems Management team, you'll work closely with line of business departments, understanding their business needs and bridging them to optimized systems.

Your primary responsibility will be to implement new IT functions and features in the systems to improve and optimize business processes, particularly in the regulatory systems domain, such as Veeva RIM and docuBridge. You'll collaborate closely with the rest of the team, line of business departments, and vendors to achieve this goal.

This position requires a good combination of IT system knowledge, business process understanding, and experience, as well as expertise in GxP, system configuration, and validation. You'll also be responsible for handling requests, questions, or needs for help from line of business departments.

An estimated salary for this position is between $120,000 and $180,000 per year, depending on location and experience.

About the Role

  • Optimize and innovate the GenDocs system (Veeva Vaults) and related processes in line of business
  • Participate in daily system management work, including configuring, implementing, and validating new system features and functions
  • Resolve daily issues and incidents from users of the systems
  • Improve procedures, work instructions, templates, and other tools to optimize systems and related processes
  • Participate in future Veeva Vault projects as (Senior) Functional Lead or (Senior) Project Manager
  • Maintain system documentation during operation
  • Liaise with line of business departments and IT Business Partners to align plans for new features and projects
  • Prepare and participate in audits and inspections of the systems

Requirements

  • Bachelor's degree in Life Science, IT, Engineering, or similar area
  • 5-8 years' work experience in the pharmaceutical or biotech industry, with 3-5 years in a similar role as System Manager
  • Practical experience with EDMS systems and preferably Veeva Vault administrator and platform certification
  • Extensive knowledge and understanding of GxP systems, GAMP, IT validation, and test management
  • Excellent communication skills in English, written and oral

About You

  • You're passionate about transforming the lives of patients through innovative cancer treatment
  • You bring rigor and excellence to your work, believing in a rooted-in-science approach to problem-solving
  • You're a generous collaborator who can work in teams with diverse backgrounds
  • You're determined to do and be your best, taking pride in enabling the best work of others on the team

Location

We offer an agile working environment that prioritizes employee work-life balance. Our offices are designed as open, community-based spaces that foster connection among employees while being immersed in state-of-the-art laboratories.



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