Senior Manager, Global Regulatory Operations – Regulatory Systems
Genmab
full-time
Posted on:
Location Type: Hybrid
Location: Copenhagen • Denmark
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Job Level
Tech Stack
About the role
- Supporting and optimizing core Regulatory Operations systems, including Veeva Vault RIM, Toolbox, Acumen Authoring Tool, and associated health authority portals
- Ensuring effective system governance, data integrity, compliance, and end-user support
- Partnering cross-functionally to enable efficient regulatory submissions, registrations, and lifecycle management activities across global markets
- Creating and/or participating in deviations, CAPAs, Change Controls, and projects related to Regulatory Operations and Veeva RIM Vault
- Partnering with Digital Enablement team for configuration testing, UAT creation and developments, and deployment into sandboxes and PROD environments
- Developing reports for stakeholders, performing impact assessments on reports due to system enhancements, and executing updates as necessary
- Attending Core team meetings and prioritizing changes from upcoming Veeva releases and enhancements
- Processing and triaging access request tickets to the RIM Vault, ticket requests for changes and support, and working on backlog change log items
- Processing requests and creating Master Data in the RIM Vault while meeting data governance criteria
- Monitoring Application Join creation and ensure eCTD data is meeting standardization and compliance requirements
- Providing ad hoc training and hands-on support for end users
- Supporting SOP and WI authoring, reviewing and approver as needed
- Coordinating updates and creations of eLearnings
- Monitoring and responding to inquiries to RIMSupport inbox and general end user technical and process support
- Assisting with periodic internal user review, periodic external user review, and annual audit trail
- Supporting RIM Registrations activities and verifications activities
- Providing authoring support, specifically Acumen templates which includes performing quality checks and converting documents to be compliant
- Using Toolbox to assist with PDF submission-readiness
Requirements
- 8 years experience
- Bachelor's degree required
- Veeva RIM System Administrator experience required, preferably 4+ years of experience
- Veeva RIM System Administrator certification highly desirable
- Significant experience in regulatory submissions, compliance, business systems technology and process
- Experience with global submissions and Health Authority portals in multiple markets (e.g US, EU, JP and ROW)
- Experience with xEVMPD is a plus
- Demonstrates problem-solving ability, flexibility and teamwork
- Excellent verbal and written communication skills
- Excellent organizational skills, ability to multitask and with attention to detail; capable of managing multiple projects within assigned timelines
- Lorenz dB publishing tool experience is a plus.
Benefits
- flexibility to work away from the office for 20%–40% of a typical schedule
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Veeva Vault RIMregulatory submissionsdata integritycomplianceCAPAsChange ControlsMaster Data managementeCTD data standardizationAcumen Authoring ToolPDF submission-readiness
Soft Skills
problem-solvingflexibilityteamworkverbal communicationwritten communicationorganizational skillsmultitaskingattention to detailproject management
Certifications
Veeva RIM System Administrator certification