System Manager, Regulatory Systems Management, Veeva RIM Professional
11 hours ago
Company Overview
">Genmab is an international biotechnology company committed to improving the lives of patients through innovative and differentiated antibody therapeutics.
With a core purpose guiding its unstoppable team, Genmab strives towards transforming the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines by 2030.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
">Job Description
">As a System Manager in Digital Systems Management, you will implement new IT functions and features in the systems to improve and optimize business processes, especially in the regulatory systems domain, like Veeva RIM and docuBridge.
This will be done in close collaboration with the rest of the team, line of business departments, and vendors of the systems.
You will act as a functional lead where you participate and contribute to the configuration and development of the systems with different SMEs from line of business, the vendor, and our own team.
An important part of the role is to be in near contact with line of business departments to handle their requests, questions, or need for help.
This requires a good combination of IT system knowledge, business process understanding and experience, and experience with GxP, system configuration, and validation.
">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 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 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.">
Personal Requirements
">- ">
- Ability to work independently as well as in teams.">
- Service minded and meeting challenges with a smile and a positive mindset.">
- Pragmatic attitude, able to balance, and see other people's perspective.">
- Take responsibility and have a personal drive.">
- Structured and systematic, and can adapt the level of right detail to the context.">
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