Functional Skills
Project Management
Business Planning
Content Marketing
Compliance and risk
Communications
Clinical Operations
Software Skills
Microsoft Office
ARGUS
Veeva Vault
InForm Electronic Data Capture
Medidata Rave CTMS
Rave Electronic Data Capture
Oracle Clinical Remote Data Capture
Certifications
CHCCertified in Healthcare Compliance
CMPECertified Medical Practice Executive
Sector Experience
Healthcare
Life Sciences & Pharma
Languages
English
Spanish
Experience
MGConsult
Corporate Strategy & Development
Medical Director, Commercial & Scientific Consultant
1/2019 - Present
Support to Pharmaceutical Quality Systems compliance with the following main responsibility addressed and focus on: Scientific Communications, Pharma Regulations, Pharmacovigilance Guidance. Regulatory Affairs, Clinical Competency (GCP), PV inspection (GVP), Medical Writing, QA systems and control, SOP redaction and review, Risk analysis, Audit planning, Dossier review.
PQE Group
Management Consulting
Senior Auditor, Executive Consultant
5/2020 - Present
Support to Pharmaceutical Quality Systems compliance with the following main responsibility addressed and focus on: Quality Assurance systems and control, Audit planning, Pharmacovigilance Guidance and Inspection (GVP), Clinical Research Guidance and Inspection (GCP), Medical and Regulatory Affairs in different regions of the world (Eurasian, FDA, Canada, LATAM, Asian, etc)
NIIT
Management Consulting
Executive Trainer & Consultant
1/2022 - Present
Guide high performance teams into Clinical Research excellence
Contribute to evaluate and define training resources and materials
Contribute to evaluate and define training resources and materials