Senior System Manager
3 weeks ago
At Genmab, we're committed to pushing the boundaries of innovation and excellence in cancer treatment and serious diseases.
The Role
We're looking for a (Senior) System Manager to join our Digital Systems Management team, where you'll help us maintain, develop, and operate our enterprise electronic document management system (EDMS), GenDocs, covering clinical development, regulatory affairs, CMC, and QA areas in R&D.
GenDocs is a global IT system based on the Veeva Vault cloud platform, supporting daily operations in our expanding R&D organization. As a System Manager, you'll implement new IT functions and features in the systems to improve and optimize business processes, especially in the regulatory systems domain.
This role requires close collaboration with the line of business departments, understanding, and bridging their business needs to optimized systems. You'll participate in the daily system management work, configure, implement, and validate new system features and functions, and resolve daily issues and incidents from users of the systems.
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, configuring, implementing, and validating new system features 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 in a relevant field, such as Life Science, IT, or Engineering
- 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's 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's an advantage but not a requirement if you have experience with IT test tools, like HP ALM, Jira, etc.
About Genmab
- We're a biotech company committed to transforming the lives of patients through innovative cancer treatment and serious disease research
- We're passionate about pushing the boundaries of innovation and excellence in our field
- We're a team of dedicated and collaborative individuals who are passionate about making a difference
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