Medical Coding Manager

Medical Coding Manager Overview

• The Medical Coding Manager provides expertise in coding adverse events, medications, and data points using MedDRA and WHO Drug dictionaries.
• Ensures accuracy and consistency of coded data across studies and projects, adhering to regulatory requirements globally.
• Acts as a resource for clinical teams on dictionary and coding-related issues, including Standard MedDRA Queries and Drug Groupings.
• Supports study design and database build by reviewing protocols and contributing to coding process documentation.
• Participates in the development of adverse events of special interest listings and dictionary term lists under supervision.
• Provides training to clinical team members on coding functions, including MedDRA structure and WHO Drug guidelines.
• Monitors coding tools and reports technical issues to ensure timelines and quality standards are met.
• Collaborates with cross-functional teams to resolve coding queries and ensure successful project outcomes.

Medical Coding Manager Key Responsibilities & Duties

• Complete medical coding activities for study milestones, ensuring adherence to GCP principles and regulatory requirements.
• Maintain synonym lists for accuracy and consistency of coded data across projects and studies.
• Participate in data reviews post dictionary migrations to ensure consistency and quality of migrated data.
• Consult with medical study directors to resolve coding issues and queries effectively.
• Provide training and develop materials relevant to medical coding functions for clinical teams.
• Identify gaps in coding dictionaries and propose terms for submission to dictionary vendors.
• Monitor coding tools and report technical issues to ensure timelines and quality standards are maintained.
• Collaborate with pharmacovigilance and data management teams for SAE coding reconciliation and related activities.

Medical Coding Manager Job Requirements

• Bachelor's degree in life sciences or equivalent licensure with significant healthcare experience.
• Minimum 4 years of coding experience using MedDRA and WHO Drug dictionaries in pharmaceutical or biotechnology settings.
• Proficiency in Central Coding, InForm, and dsNavigator or similar coding applications.
• In-depth knowledge of MedDRA and WHO Drug dictionaries and their applications.
• Strong understanding of GCP principles, regulatory requirements, and industry best practices.
• Excellent communication skills and ability to work collaboratively in a team environment.
• Experience in data management and pharmacovigilance is a plus.
• Commitment to process improvement and streamlining workflows for added value.