Job DescriptionEisai Inc. seeks an Associate Director (AD), Medical Coding to work onsite at our Woodcliff Lake, NJ location.The Associate Director, Medical Coding is an expert in the industry standard medical coding dictionaries, preferably with experience in legacy coding terminologies (WHO ART, COSTART). They perform coding using both MedDRA and WHO Drug, ensuring accuracy and consistency of the coded data both within a study and across protocols. They review coded items across studies within a project and across therapeutic areas to ensure consistency and compliance with Eisai Coding Guidelines. This individual will be responsible for multiple studies both within and across multiple compounds ensuring coding is complete in order to meet all study timelines and in support of planned NDAs/sNDAs and interim analyses. In addition, the AD Medical Coding will review and approve coding the assignments by the coding managers providing feedback, as well as participating/leading the weekly coding consistency reviews. The AD Medical Coding is also responsible for the periodic review of synonym/autosuggestion lists and participates in dictionary upgrade preparations.The AD Medical Coding Manager acts as a resource to the study teams on dictionary and coding- related issues and provides expertise in the use of the dictionaries to identify events, conditions and medications of interest for study analyses. They support Biostatistics and Statistical Programming in the leveling of dictionary versions in legacy data sets and, as necessary, coding/recoding of legacy data to be included in submissions to health authorities. This individual ensures medical coding deliverables follow the regulatory authorities requirements globally. The AD Medical Coding monitors changing regulatory requirements for the submission of coded data and escalates to the affected department management. The AD interacts as a Point of Contact (POC) with the coding dictionary vendors on multiple topics including, but not limited to, subscription renewals, change requests, evaluation of coding tools, and downloading of dictionary files/documentation.The AD Medical Coding monitors the performance of the Eisai coding tools, reports issues to vendor support for identification and monitors progress of the resolutions. They work with Eisai IT, NBG Data Operations and the coding tool vendors participates in testing and validation activities as the Medical Coding Subject Matter Expert (SME), evaluates the Eisai coding tools for maximum efficiency, opportunities for process improvement and appropriate use of resources.In addition, the AD Medical Coding participates in the development and maintenance of coding related process documents and job aids and provides support to, and mentoring of, the coding managers as needed.Job QualificationsThe successful candidate must have the following skills and background:10 or more years of medical coding experience for clinical trials in a pharmaceutical or biotechnology company.A health care professional with understanding of the pathophysiology of diseases, preferably with prior work experience in a health care institution.Expert knowledge of MedDRA and WHO Drug dictionaries.Prior experience in submitting change requests, reviewing proposed complex changes from the coding dictionary vendors [MSSO, Uppsala Monitoring Centre].Experience in creating and maintaining search groupings using the coding dictionaries to identify Events of Interest or medications, is preferred.Experience with Oracle Central Coding, Inform or other coding applications.Prior experience working with technical teams including vendor support, coding set up, dictionary migration and resolution of systems issues.Ability to work both independently and collaboratively in a team environment.Excellent oral and written communication skills.Knowledge of industry best practices, regulatory requirements and Good Clinical Practice (GCP).Experience working with study teams including educating teams on coding processes, along with the structure and use of the coding dictionaries.Experience in training and mentoring of staff.Experience in the development and maintenance of process documents [SOPs, SWPs, guidelines].Ability to build successful relationships with cross-functional team members.Data Management and/or Pharmacovigilance experience is a plus.Prior experience working with a delegated data management process a plus.Embracing and contributing to our culture of process improvements with a focus on streamlining processes to add value in the support of our business needs.HS Diploma and certification or licensure with significant experience in an allied health care field is required.Bachelor's degree or higher in a life science (e.g. Nursing, Pharmacy) is preferred.This position will be based at our Woodcliff Lake offices and is an onsite (not remote) working position. Relocation is not provided. Associated topics: account, biller, cbo, coding, collector, desk, medical biller, medical coding, medical transcriptionist, transcription medical
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.