Senior Medical Coding Manager – MedDRA/WHO Drug Expert

Eisai US; United States; Remote; USD 99.000 - 131.000; Vollzeit

Benefits dieser Stelle

Annual Incentive Plan

Employee benefits

Zusammenfassung

Eisai US is seeking a Medical Coding Manager to provide coding expertise for clinical teams, using MedDRA and WHO Drug dictionaries. You will ensure data accuracy, support adverse event listings, and maintain coding processes globally in line with regulatory requirements.

Significant experience with MedDRA/WHO Drug, DS tools, and training duties are key. The role emphasizes collaboration with Study Directors and data management, with an annual base salary in Eisai's transparency framework.

Qualifikationen

• Minimum 4 years of coding experience using MedDRA and WHO Drug dictionaries in a pharmaceutical/biotech setting.
• Bachelor's degree or higher in life science as a requirement.

Aufgaben

• Completes medical coding activities for all study milestones and support of evolving business practices.
• Maintains synonym lists to ensure accuracy and consistency of coded data.
• Participates in data review post dictionary migrations to ensure consistency.
• Applies GCP principles to medical coding activities per SOPs and guidelines.
• Ensures coding meets regulatory requirements.
• Consults with Study Directors to resolve coding issues.
• Participates in SAE coding reconciliation and QC interactions.
• Provides training on MedDRA, SMQs, and WHO Drug to clinical teams.
• Contributes to development of training materials and job aids.
• Reviews coding process documents under development.
• Identifies gaps and proposes terms for dictionary updates.
• Monitors coding tools status and reports issues to head of Medical Coding.

Kenntnisse

MedDRA

WHO Drug dictionaries

Regulatory knowledge

GCP

Cross-functional collaboration

Data Management

Pharmacovigilance

Ausbildung

Bachelor's degree or higher in life science

Tools

InForm

dsNavigator

Jobbeschreibung

Eisai US is seeking a Medical Coding Manager to provide coding expertise for clinical teams, using MedDRA and WHO Drug dictionaries. You will ensure data accuracy, support adverse event listings, and maintain coding processes globally in line with regulatory requirements.

Significant experience with MedDRA/WHO Drug, DS tools, and training duties are key. The role emphasizes collaboration with Study Directors and data management, with an annual base salary in Eisai's transparency framework.