Function Lead Medical Coding

Responsibilities

• Define, maintain and implement the outsourcing strategy and processes for global Medical Coding services in clinical studies including definition of performance and quality measures including MedDRA and WHODrug
• Direct and oversee the operations of Medical Coding service vendors
• In close contact with vendors, continuously transform learnings from oversight to collaboration enhancements
• Specify, develop and implement SAS programs and macros in support of all medical coding, oversight and dictionary maintenance tasks. In close collaboration with partner functions you will ensure that medical coding systems meet business requirements and drive continuous system enhancements
• Monitor the regulatory requirements and system landscape in the area of Medical Coding for required adaptations and possible enhancements of internal processes, outsourcing strategy and systems.

Requirements

• Master’s degree in life science area with technical focus or bachelor’s degree in same area with equivalent on-the-job experience
• Several years of experience in the area of Medical Coding (MedDRA and WHODrug) and/or analysis/interpretation of coded data, including use/development of medical dictionary searches
• Solid analytical and SAS programming skills
• Experience in clinical trial databases and/or pharmacovigilance databases
• Ideally experience In Vendor management and oversight
• Firm knowledge of regulatory environment in pharmacovigilance and Good Clinical Practice
• Excellent networking and communication skills and fluent in written and spoken English