General Skills:Experienced, creative, and curious consultant, and project leaderExperience in big projects (> 1 Mio €) on upper management levelTeam player & leaderExcellent social capabilities and subject matter skillsResult-oriented and committed to added-value thoughtMediator between business and IT functionProven international mindset and experienceOpen-mindednessStructured, rational, realistic and logicalCost-conscious, efficient and effective performanceStraightforwardCooperative and communicativeSpecialized Domain Experience:Long track record (>20years) in pharmaceutical industry, primarily in Regulatory Affairs & Regulatory OperationsRegulatory Information ManagementIDMPXEVMPD, EVMPD, EVPRMGlobal Labeling, PIM, SPL/PLR and related XML, PIM concepts, PIM migrations, PIM tool know-how, implementing PIM tools, PIM introductions & trainingTranslation ManagementSubmission & content planning (regulatory events) & tracking (registrations)Regulatory Document Managemente-submission publishing (eCTD) expert
Listed skills include Regulatory Affairs, Document Management, Pharmaceutical Industry, Computer System Validation, and 45 others.