Experience in global drug development regulations, regulatory submissions, lifecycle management, compliance,
business systems technology and process.
Knowledge and experience with industry standards is required. Experience with applying knowledge of information management involving undefined frameworks with medium technical complexity and defined scope.
Understanding regulatory publishing and information management tools is preferred. Experience with Veeva RIM strongly preferred.
Experience with Project management and Business process improvement Applications
Support with SCP rollout
Create support materials for workshops/user support
Provide process-specific end-user support during roll-out
Evaluate business processes/training materials to identify opportunities for efficiencies/clarification.
PM support (either from this resource or existing Identified PM)
Acumen Templates
Submissions readiness and templates roll-out
BAU activities
Support with end user enquiries (technical or regulatory in nature), as part of migration and ad hoc
Sheds/GRACE/Archive enrichment review, critical data evaluation based on Regulatory expertise
Support with Annex H-Business Partner Agreement report reconciliation
Support in the identification and execution of materials to support user engagement activities