Medical Coding Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Perform medical coding tasks for all study milestones and evolving business practices.

• Code and recode adverse events, concomitant medications, and other data points utilizing MedDRA and WHO Drug dictionaries.

• Review coded data listings to ensure accuracy and consistency within and across studies and projects.

• Liaise with clinical representatives to address inquiries from quality-control data reviews.

• Provide guidance to clinical teams on dictionary and coding matters, including Standard MedDRA Queries and Standard Drug Groupings.

• Engage in the development of adverse events of special interest listings and other dictionary-term compilations.

• Ensure that medical coding deliverables adhere to study timelines and global regulatory standards.

• Act as a representative for Medical Coding on clinical teams.

• Review study protocols to assist with study design, database construction, and planned analyses.

• Contribute to the creation of coding process documents, including Coding Guidelines.

• Maintain synonym lists and evaluate data following dictionary migrations.

• Implement GCP principles while adhering to SOPs, SWPs, and related guidelines.

• Consult with Medical Study Directors and reviewers to resolve coding issues and inquiries.

• Participate in SAE coding reconciliation with Data Management and Pharmacovigilance.

• Provide medical coding training and contribute to training materials and job aids.

• Review coding process documents that are currently in development.

• Identify deficiencies in coding dictionaries and suggest terms to dictionary vendors.

• Monitor coding tools and report any technical issues impacting timelines or quality to Medical Coding leadership and/or Data Operations.

⛳️ Requirements

• A minimum of 4 years of coding experience using MedDRA and WHO Drug dictionaries in a pharmaceutical or biotechnology environment.

• A healthcare professional with a solid understanding of disease pathophysiology.

• Extensive knowledge of MedDRA and WHO Drug Dictionaries.

• Previous experience with Central Coding and InForm; familiarity with dsNavigator or other coding applications is an added advantage.

• Capability to work independently with minimal supervision in a collaborative team setting.

• Exceptional oral and written communication skills.

• Understanding of industry best practices, regulatory standards, and GCP.

• Ability to cultivate successful relationships with cross-functional team members.

• Commitment to enhancing processes, streamlining operations, and delivering value.

• A Bachelor’s degree or higher in a life science field, such as Nursing or Pharmacy, or equivalent licensure along with significant experience in an allied healthcare domain.

• Experience in Data Management and/or Pharmacovigilance is a plus.

🏝️ Benefits

• Eligibility to take part in the Eisai Inc. Annual Incentive Plan.

• Eligibility to join Company employee benefit programs.

• Additional benefits may be available for this position.