Medical Coding Mgr

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease.

About the role

The Medical Coding Manager provides medical coding expertise to clinical teams by coding and recoding adverse events, concomitant medications, and other data points using MedDRA and WHO Drug dictionaries. This role reviews coded data listings for accuracy and consistency within a study, within a project, and across projects, and follows up with clinical representatives regarding questions arising from QC data review.

The Medical Coding Manager acts as a resource to clinical teams on dictionary and coding-related issues, including the use of Standard MedDRA Queries (SMQs) and Standard Drug Groupings (SDGs). This role participates in developing adverse events of special interest (AESI) listings and other dictionary term lists for identifying subjects of interest under senior supervision. The Manager ensures medical coding deliverables meet study timelines and comply with global regulatory requirements while representing Medical Coding on clinical teams.

The role involves reviewing study protocols to support study design, database build, and planned analyses utilizing dictionary coding. The Manager also contributes to the development and maintenance of coding process documents, such as Coding Guidelines.

Responsibilities

• Completes medical coding activities for all study milestones and evolving business practices.
• Maintains synonym lists to ensure accuracy and consistency of coded data.
• Participates in data review post-dictionary migrations to ensure consistency in migrated data.
• Applies GCP principles to medical coding activities following SOPs, SWPs, and related guidelines.
• Ensures coding meets all regulatory authorities’ requirements.
• Consults with medical Study Directors and reviewers to resolve medical coding issues or queries.
• Participates in SAE coding reconciliation, responding to questions from Data Management and Pharmacovigilance.
• Provides training relevant to the medical coding function to clinical team members (e.g., MedDRA structure, SMQs, WHO Drug).
• Provides input into the development of training materials and job aids.
• Reviews coding process documents under development.
• Identifies gaps in coding dictionaries and proposes terms for consideration to be submitted to dictionary vendors.
• Assists in monitoring the status of coding tools and reports technical issues that could impact timelines and quality of coding.

Requirements

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

Pay

The annual base salary range for this role is $99,900–$131,100. Final pay determinations depend on factors including experience level, education, knowledge, and skills. This position is eligible to participate in Eisai Inc.’s Annual Incentive Plan.

Benefits

Employees are eligible to participate in Company employee benefit programs. Additional information on compensation and benefits is available at Eisai Careers. Certain other benefits may also be available for this position.