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