Regulatory Systems Management Expert
1 month ago
Genmab is a global biotechnology company that develops innovative antibody therapeutics. Our team of experts strives to transform the lives of patients with cancer and other serious diseases.
We are currently seeking a skilled Regulatory Systems Management Expert to join our team. This is an exciting opportunity for a motivated professional to take on a key role in maintaining, developing, and operating our enterprise electronic document management system (EDMS).
The EDMS, GenDocs, is a critical component of our regulatory affairs and clinical development operations. As a Regulatory Systems Management Expert, you will work closely with our cross-functional teams to ensure seamless integration and compliance with regulatory requirements.
You will be responsible for implementing new IT functions and features in the systems to improve business processes, especially in the regulatory systems domain. Your expertise will be instrumental in bridging the gap between line-of-business departments and optimized systems.
This role requires a unique blend of IT system knowledge, business process understanding, and experience with GxP systems, GAMP, IT validation, and test management. If you have a passion for innovation and excellence, we encourage you to apply for this challenging and rewarding opportunity.
About the Role
- Lead and contribute to the optimization and innovation of the GenDocs system and related processes.
- Participate in daily system management work, configuring, implementing, and validating new system features and functions.
- Resolve daily issues and incidents from users of the systems.
- Continue to improve procedures, work instructions, templates, and other tools to optimize systems and related processes.
- Participate in future Veeva Vault projects as a functional lead or 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 field.
- At least 5-8 years of work experience in the pharmaceutical or biotech industry, with 3-5 years' experience in a similar role.
- Practical work experience with EDMS systems, preferably Veeva Vault administrator and platform certification.
- Experience working with regulatory affairs, clinical development, pharmacovigilance, or similar line-of-business areas.
- Extensive knowledge and understanding of GxP systems, GAMP, IT validation, and test management.
- Participation in IT GxP projects, either as a project SME, functional lead, or project manager.
- Excellent communication skills in English, written and oral.
Salary Range: €80,000 - €120,000 per annum, depending on experience and qualifications.
Location: Copenhagen, Denmark; Utrecht, Netherlands; Princeton, NJ, USA.
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