Medical Coding Manager

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Eisai US

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1995

💊 Pharmaceuticals

🏥 Healthcare

Pharmaceuticals • Healthcare

Eisai US is the United States arm of Eisai Inc. , a global pharmaceutical company focused on researching, developing, manufacturing and commercializing medicines — particularly in neurology (including Alzheimer’s disease) and oncology. With nearly 40 years of U. S. R&D and manufacturing presence, Eisai US runs clinical trials, patient support programs, community involvement and corporate responsibility initiatives under its “human health care” mission, and emphasizes a science-driven pipeline and collaborations to address areas of high medical need.

📋 Description

• Complete medical coding activities for all study milestones and evolving business practices • Code and recode adverse events, concomitant medications, and other data points using MedDRA and WHO Drug dictionaries • Review coded data listings for accuracy and consistency within studies, projects, and across projects • Follow up with clinical representatives regarding questions from quality-control data reviews • Advise clinical teams on dictionary and coding issues, including Standard MedDRA Queries and Standard Drug Groupings • Participate in developing adverse events of special interest listings and other dictionary-term lists • Ensure medical coding deliverables meet study timelines and global regulatory requirements • Represent Medical Coding on clinical teams • Review study protocols to support study design, database build, and planned analyses • Contribute to coding process documents, including Coding Guidelines • Maintain synonym lists and review data after dictionary migrations • Apply GCP principles while following SOPs, SWPs, and related guidelines • Consult with Medical Study Directors and reviewers to resolve coding issues and queries • Participate in SAE coding reconciliation with Data Management and Pharmacovigilance • Provide medical coding training and input into training materials and job aids • Review coding process documents under development • Identify gaps in coding dictionaries and propose terms to dictionary vendors • Monitor coding tools and report technical issues affecting timelines or quality to Medical Coding leadership and/or Data Operations

🎯 Requirements

• Minimum 4 years of coding experience using MedDRA and WHO Drug dictionaries in a pharmaceutical or biotechnology company • Health care professional with understanding of disease pathophysiology • In-depth knowledge of MedDRA and WHO Drug Dictionaries • Prior experience with Central Coding and InForm; dsNavigator or other coding applications additionally beneficial • Ability to work with minimal supervision in a team environment • Excellent oral and written communication • Knowledge of industry best practices, regulatory requirements, and GCP • Ability to build successful relationships with cross-functional team members • Commitment to process improvement, streamlining processes, and adding value • Bachelor's degree or higher in a life science, such as Nursing or Pharmacy, or equivalent licensure and significant experience in an allied health care field • Data Management and/or Pharmacovigilance experience is a plus

🏖️ Benefits

• Eligibility to participate in the Eisai Inc. Annual Incentive Plan • Eligibility to participate in Company employee benefit programs • Certain other benefits may be available for this position