Medical Coding Manager: MedDRA Expert & Regulatory Leader

Eisai US; Northern (KY); Hybrid; USD 100,000 - 131,000; Full time

Benefits offered by this job

Annual Incentive Plan

Benefits package

Job summary

Eisai Inc. is seeking a Medical Coding Manager in the United States to provide expert coding for clinical studies, using MedDRA and WHO Drug dictionaries and ensuring data accuracy across projects.

The role includes reviewing data listings, supporting study design and dictionary maintenance, and training clinical teams on MedDRA structures, SMQs, and SDGs while adhering to regulatory requirements.

Qualifications

• Minimum 4 years of coding experience using MedDRA and WHO Drug dictionaries.
• Health care professional with understanding of disease pathophysiology.
• Deep knowledge of MedDRA and WHO Drug Dictionaries.
• Experience with Central Coding, InForm; dsNavigator or similar tools.
• Strong written and oral communication; team oriented.

Responsibilities

• Completes medical coding activities for all study milestones and in support of evolving business practices.
• Maintains synonym lists to ensure accuracy and consistency of coded data.
• Participates in data review after dictionary migrations for consistency.
• Applies GCP principles to medical coding activities following SOPs and guidelines.
• Ensures coding meets regulatory requirements and discusses issues with study teams.

Skills

MedDRA

WHO Drug

GCP principles

Regulatory knowledge

Communication skills

Education

Bachelor's degree in life science

Tools

Central Coding

InForm

dsNavigator

Job description

Eisai Inc. is seeking a Medical Coding Manager in the United States to provide expert coding for clinical studies, using MedDRA and WHO Drug dictionaries and ensuring data accuracy across projects.

The role includes reviewing data listings, supporting study design and dictionary maintenance, and training clinical teams on MedDRA structures, SMQs, and SDGs while adhering to regulatory requirements.