Preferred Experience And Skills<\/p>\n<\/u><\/strong>Relevant experience in the field of Regulatory Information Management within the Pharmaceutical Industry<\/p>\n
Expertise with Regulatory Information Management Processes Registrations Data Management, Submission Planning, Submission Content Planning, Content Management, Submissions Publishing, Labeling Management<\/p>\n
Supporting implementation & maintenance of Regulatory Information Management Systems<\/p>\n
Supporting data migration, data assessment, data enrichment, data transformation and data readiness in the context of Regulatory Information Management System<\/p>\n
Reasonable understanding of Regulatory business processes Marketing Authorization Applications, License Renewals, Variations, Labeling Submissions<\/p>\n
Experience defining & implementing data standards within RIMS naming convention, reference data standards, master data standards<\/p>\n
Good understanding & experience with Veeva RIMS, data model and processes<\/p>\n
Experience with multiple RIMS platforms is an advantage: Veeva, Generis, Liquent Insight, Aris Global’s LifeSphere, Amplexor<\/p>\n
Experience with Document Management systems Documentum, FirstDoc, etc.<\/p>\n
Experience with analyzing regulatory information, designing and developing reports, visualizations on BI platforms such as Spotfire, Power BI, Qlik Sense, etc.<\/p>\n
Knowledge of ISO IDMP Standards, SPOR & EU Implementation Guide, xEVMPD, PQCMC is an advantage<\/p>\n
Ability to drive adoption of new RIMS platform within business community<\/p>\n
Effective communication, presentation and interpersonal skills, ability to collaborate and engage effectively with the entire eco system (customer, vendor, Genpact)<\/p>\n
Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines<\/p>\n
Expert on life sciences compliance and computer systems validation requirements<\/p>\n
Leads Offshore Project Delivery Teams
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