Medical Coding Mgr

Eisai US · United States

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 that is 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. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Medical Coding Manager provides medical coding expertise to clinical teams by coding/recoding of adverse events, concomitant medications and other data points using MedDRA and WHO Drug dictionaries. This role reviews the coded data listings for accuracy and consistency within a study, within a project, and across projects, and follows up with clinical representative(s) as to questions arising from the QC data review. The Medical Coding Manager acts as a resource to the clinical teams on dictionary and coding related issues including, but not limited to, use of the Standard MedDRA Queries (SMQs) and Standard Drug Groupings (SDGs). This role participates in the development of adverse events of special interest (AESI) listings, and other lists of dictionary terms for use in identifying subjects of interest, under the supervision of a senior group member. This role ensures medical coding deliverables meet study timelines and follow regulatory authorities’ requirements globally and represents Medical Coding on the clinical teams. The Manager reviews study protocols in order to support the study design, database build and planned analyses utilizing the dictionary coding and contributes to the development and maintenance of coding process documents, e.g. Coding Guidelines. The Medical Coding Manager provides medical coding expertise to clinical teams by coding/recoding of adverse events, concomitant medications and other data points using MedDRA and WHO Drug dictionaries. This role reviews the coded data listings for accuracy and consistency within a study, within a project, and across projects, and follows up with clinical representative(s) as to questions arising from the QC data review. The Medical Coding Manager acts as a resource to the clinical teams on dictionary and coding related issues including, but not limited to, use of the Standard MedDRA Queries (SMQs) and Standard Drug Groupings (SDGs). This role participates in the development of adverse events of special interest (AESI) listings, and other lists of dictionary terms for use in identifying subjects of interest, under the supervision of a senior group member. This role ensures medical coding deliverables meet study timelines and follow regulatory authorities’ requirements globally and represents Medical Coding on the clinical teams. The Manager reviews study protocols in order to support the study design, database build and planned analyses utilizing the dictionary coding and contributes to the development and maintenance of coding process documents, e.g. Coding Guidelines. Essential Functions

• Completes medical coding activities for all study milestones and in 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 in the 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/queries. Participates in SAE coding reconciliation, responding to questions from Data Management and Pharmacovigilance. Provides training relevant to medical coding function to clinical team members as needed, 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 the coding dictionaries, proposing terms to the group for consideration to be submitted to the dictionary vendors.
• Assists in monitoring the status of the coding tools, reports technical issues that could impact times lines and quality of coding to the head of Medical Coding and/or Data Operations.

• Minimum 4 years of coding experience using MedDRA and WHO Drug dictionaries in a pharmaceutical or biotechnology company.
• A health care professional with understanding of the pathophysiology of disease.
• In-depth knowledge of MedDRA and WHO Drug Dictionaries.
• Prior experience with Central Coding, InForm; additional: dsNavigator or other coding applications.
• 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.
• Embracing and contributing to our culture of 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 in lieu of a degree, equivalent licensure and significant experience in an allied health care field.
• Data Management and/or Pharmacovigilance experience is a plus.