Genevieve Lötter

Clinical Operations professional with 8+ years in regulated pharmaceutical environments. Skilled in TMF maintenance, regulatory submissions, and GCP-compliant documentation across global teams. Proficient in SAP and Veeva with a strong track record of audit-ready documentation.

Marketing Assistant / Clinical & Executive Support - Organon South Africa (Pty) Ltd - Women's Health Division

(2021-01 - 2024-06)

• Managed clinical trial documentation, regulatory submission packages, and TMF maintenance to ensure inspection-readiness
• Operated SAP and Veeva Systems to execute documentation workflows, approvals, and version control at scale
• Collaborated with cross-functional global teams to deliver study-related milestones in compliance with GCP and ICH guidelines

Administrative Assistant - MSD (Pty) Ltd - Gauteng

(2017-01 - 2021-01)

• Delivered end-to-end administrative and compliance support across regulatory, commercial, and financial documentation streams
• Managed SAP-based purchase orders, vendor onboarding, and approval tracking in alignment with pharmaceutical SOPs
• Coordinated global cross-functional meetings and maintained audit-ready records under strict document retention standards

Digital Marketing Degree - Digital Marketing - Red & Yellow Creative School of Business The Exceptional PA, EA & Administrative Professional - Administrative Professional Development - Marc Evans