An accomplished records and information management specialist with proven skill set including 16 years’ experience within records retention and information management. Focus on health authority audit preparedness, compliance, security, and lifecycle management requirements of key company proprietary media encompassing all GXP documentation. Actively liaise with internal areas and external groups including CMOs and CROs to ensure accurate retrieval of Regulatory, Clinical, QA, and Pharmacovigilance media as required. Practice accurate and effective paper and EDMS tracking of global records including regulatory applications, clinical CTAs, pharmacovigilance and safety, guidelines, SOPs, and reference materials. Self-motivated team player with effective verbal and written communication skills.

Highlights:

• Filing
• Management
• Quality
• Quality Assurance
• Quality Control
• Retention
• Document Management
• Documentation
• Information Technology
• Records and Information Management
• Regulatory
• Operations
• Record Coordinator
• Compliance
• Regulatory Operations