Medical Coe - Regional Bt Manager
Provide tools and solutions to improve the Clinical Research & Regulatory Affairs functions within the LA/AfME region, seeking to optimize the Medical area global/regional processes• Regulatory Tracking Management System (RTMS) - Provide automated capabilities & controls to optimize the PGP Regulatory product submission processes at a country level. Implementation for Latin America, AfME and a various Asia countries (over 20 countries rolled out). Over 7.000 submissions processes currently supported (New Registrations, Renewals, Variations and PGM Transfers).• Promotional Material Approval Workflow Latin America - Optimize the Regional Promotional Material Approval processes, from the initial PM development stage, through the validation, review & final approval phases, assuring adherence & compliance to existing quality corporate standards and current SOPs. Implementation for ACTs in Mexico, Dubai and NYHQ, as well as Colombia, Ecuador, Peru, Chile & Bolivia. Ongoing rollouts in South Africa and Costa Rica.• Investigational Product Management (IPM) - Optimize the Inventory Control process of Drug/Supplies used in LA Clinical Trials. Solution implemented for Colombia and Venezuela.• Introduce Collaboration tool (Enlace LA) to Regulatory areas in Latin America (14 countries) to foster sharing & collaboration around LPDs, CDS and Regional Artworks in local languagesComplement & support DMi global projects & activities• Adequate MBSS Argus support model (HP regional service desk) in Latin America, considering limited access to Pfizer Global Service Desk tools• Leverage Embrace – CTRM communications • Support user requests for over 10 global medical applications