Regulatory Systems Management Lead

5 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time
About the Position
The System Manager will be responsible for implementing new IT functions and features in GenDocs to improve and optimize business processes, especially in regulatory systems management. The ideal candidate will have extensive experience with EDMS systems, preferably Veeva Vault administration and platform certification, as well as a strong understanding of GxP systems, GAMP, IT validation, and test management. Experience with IT GxP projects and excellent communication skills in English are essential. The position involves close interaction with various stakeholders, including end-users, vendors, and external partners, requiring a pragmatic attitude to handle requests, questions, or needs for help from line of business departments.

Responsibilities
  • Implement new IT functions and features in GenDocs to improve and optimize business processes, especially in regulatory systems management.
  • Configure, implement, and validate new system features and functions.
  • Resolve daily issues and incidents from users of the systems.


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