Global Regulatory Compliance and Risk Oversight
14 months
Role: Risk Analyst
Client: Johnson & Johnson
Project Size: $30M
Description:
Conducted regulatory compliance and risk review activities across global clinical sites using Veeva QMS. Standardized change control processes and ensured consistent audit preparedness. Helped the organization achieve 0 critical FDA findings during inspections.
Skills Used
- Regulatory audit readiness
- Risk assessment
- Veeva QMS,
- Global compliance documentation
- FDA/EMA audit processes