Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since then we have rapidly grown to become a fully integrated pharmaceutical business. Eisai’s areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.
Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company’s areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs.
Eisai recognizes that we are the Company’s greatest asset. To this, Eisai is committed to providing us an enabling and empowering work environment that allows us to grow and thrive. In our diverse organization, we adhere to a strict commitment to our values of Integrity, Respect, Professionalism, Quality and Teamwork. We therefore invite you to explore this job opportunity or any others that may match your qualifications and interests.
Under the guidance of the Senior Director, Coding & Medical Data Science within the Oncology Business Group (OBG), the Medical Coding Manager performs review of selected codes assigned by first pass coders using MedDRA and WHO-Drug Dictionaries (WHODD). This role is responsible for ensuring accuracy and consistency of coded data within and across protocols and ensures that medical coding deliverables follow regulatory authority requirements at the global platform. This role will also code terms if the first pass coders are having difficulty.
Responsibilities include but are not limited to perform medical coding activities from CRF review of codable pages to coding approval by the Clinical Study Director at Database lock.
Supports the Coding guidelines to ensure this is consistent with the MSSO and UMC guidelines and across OBG processes. Contributes to the synonym-lists to ensure accuracy and consistency of the coded data. Applies GCP principles to ensure all medical coding activities follow SOPs, SWPs and associated guidelines. Participates in SAE coding reconciliation.
Collaborates with colleagues within the study teams across therapeutic areas on coding-related matter especially System –related issues or SAE reconciliation. Consults with Study Directors to resolve medical coding issues/querie, if necessary. Interface with Data Operations during study build coding set up, dictionary migration and resolution on systems issue.
Responsibility includes ability to generate search groupings of similar terms for Adverse Events of Interest or medication of interest.
Interacts with Clinical Safety Data Review group in Review of AESI and take on quality check of clinical summaries if needed.
The Medical Coding Manager may also be responsible for training, advising and providing direction for Medical Coding contractors.
• Ensures completion of medical coding activities from CRF review of codable pages to coding review and final sign-off of coding approval form by the Clinical Study Director.
• Performs detailed review of selected codes assigned by first pass coder using MedDRA and WHODD any other company dictionary
• Posts coding query and generates coding listings for review to Study Directors
• Generates grouping of terms for Adverse Events of Interest or Medications of Interest and Interacts with Clinical Safety Data Review team in review of the AESI data
• Contributes to Oncology coding convention, dictionary upversioning and synonym list
• Coordinates with Data Operations in Study Startup of coding in clinical database and Coding set –up in Coding Environment. Identify and coordinates technical issues regarding coding
• Participates in the development and implementation of department standards and documents as needed
• Bachelor’s degree in relevant biological science or healthcare field
• Minimum of 5 years of experience as a Medical Coder.
• Minimum of 5 years of experience using MedDRA, WHODD, I/J Review, Inform, ds-Navigator, Excel, and Central Coding or other coding tools.
• Requires 4 years of experience supporting Oncology studies and reviewing codeable Case Report Forms; managing CRO global team and supporting Oncology studies; using technical skills such as dictionary manager and setting algorithms (which may have been obtained concurrently).
• Experience handling end to end clinical trials independently.
Here at Eisai, we are rewarded with highly competitive salaries, incentive awards, a comprehensive benefits package (Medical, Dental, Prescription and Vision Plans) 401k, Flexible Spending Accounts, Life and Disability Insurance, and other great programs.
Eisai is committed to a policy of equal employment opportunity for all employees and applicants. The Company also strives for a work environment free from discrimination and harassment. It is Eisai’s policy to comply with all applicable federal, state and local laws and regulations regarding nondiscrimination in employment and not to discriminate against any employee or applicant for employment on the basis of any protected status, including, but not limited to, race, color, national origin, religion, sex, age, disability, pregnancy, ancestry, creed, alienage or citizenship status, sexual orientation, gender identity and expression, marital status, military/veteran status, genetic information, or any other protected characteristic as established by law.
Eisai is an Equal Opportunity Employer – Minority / Female / Disability / Vet from tblHiringOrgDefaults
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Location/Region: Westwood, NJ (07675)