Senior System Manager

4 weeks ago

Copenhagen, Copenhagen, Denmark Genmab Full time

At Genmab, we're committed to building extraordinary futures together, by developing innovative antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases.

The Role

We're seeking a (Senior) System Manager to help us maintain, develop, and operate 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.

Key Responsibilities

  • Lead and contribute to the optimization and innovation of the GenDocs system (Veeva Vaults) and docuBridge, and their related processes in line of business
  • Participate in the daily system management work, for example configure, implement and validate new system feature and functions
  • Participate in the resolution of daily issues and incidents from users of the systems
  • Continue to improve procedures, work instructions, templates, and other tools to optimize the systems and related processes for operating and maintaining the systems
  • Participate in future Veeva Vault projects as (Senior) Functional Lead, or as (Senior) Project Manager
  • Maintain the system documentation during the operation of the systems
  • Liaise with line of business departments and IT Business Partners to align plans for new features and projects for the future development of the systems
  • Prepare and participate during audits and inspections of the systems

Requirements

  • We expect that you have a bachelor's degree e.g. in Life Science, IT, Engineering or similar area
  • You have at least 5-8 years of work experience from the pharmaceutical or biotech industry, and 3-5 years' experience from a similar role as system manager
  • You have practical work experience with EDMS systems, and preferably Veeva Vault administrator and platform certification
  • It is an advantage if you have worked or collaborated with regulatory affairs, clinical development, pharmacovigilance, or a similar line of business areas during your career
  • You have extensive knowledge and understanding of GxP systems, GAMP, IT validation, and test management
  • You have participated in IT GxP projects, either as project SME, (Senior) Functional Lead, or (Senior) Project Manager
  • You have excellent communication skills in English, written and oral
  • It is an advantage but not a requirement if you have experience with IT test tools, like HP ALM, Jira, etc.

About Genmab

Genmab is a biotechnology company that leverages the effectiveness of an agile working environment 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.

What We Offer

  • A dynamic and expanding R&D organization
  • A global IT system in Genmab based on the Veeva Vault cloud platform
  • Opportunities for professional growth and development
  • A collaborative and innovative work environment

How to Apply

Interested candidates should submit their application, including a cover letter and resume, to the contact information provided.

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