AbbVie Documentation and Compliance L06 at AbbVie managing VAULT eTMF system utilization and project managing business process improvements. Acts as SME for CDC processes and leads training and mentoring.
Responsibilities
Manages day-to-day eTMF system utilization by: -managing the implementation of VAULT eTMF system enhancements across the business -managing initial and ongoing training/coaching on system functionality and processes to all internal and external VAULT eTMF users -works collaboratively with study support colleagues to coordinate audit and inspection readiness activities related to eTMF; -works collaboratively with study support colleagues to ensure quality checks are being conducted on the eTMF
Project Manager for the planning and execution of eTMF transfers to/from external partners.
Participates in the review of and assessment of metrics/ dashboards.
Evaluates and updates work instructions related to department processes.
Project manages the process of evaluating and updating the artifact maps/Expected Document Lists.
Complies with GCP, AbbVie SOPs and functional area processes.
Reports to an Assistant/Associate Director and will have direct reports.
Qualification
Proven communicationDemonstrates problem solving skills
Required
Bachelor degree or international equivalent is required, degree related to IT/Systems preferred
With at least 6 years Pharma experience or related professional experience.
Demonstration of successful coaching/mentoring in a matrix environment.
Proven communication, organizational, project management and leadership skills.
Demonstrates problem solving skills
Competent utilization of electronic systems
Possesses a high level of core and technical competencies related to development, product, and trial master file maintenance and processes
Proven successful coaching/mentoring in a matrix environment
