Job Description

Medical Coder
Job Number: 21-05744
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Medical Coder for our client in Summit, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
  • Responsibilities will include, but are not limited to: For pre-defined subset of Assets subject to client’s Processes and management in the Drug Safety Database and corresponding systems:
    • Maintain Medical Coding Processes, procedures, and training materials in compliance with GCP and GVP requirements, Client Quality Standards, and Client' Quality Management System (QMS) principles of integrated, patient-centric, and risk-based decision-making
    • Develop a consistent medical coding strategy for use across the Safety Database
    • Develop & maintain coding convention materials; liaise with functional areas and training groups in implementing coding standards
    • Review and assess the mapping of terms that are not auto-encoded
    • Manage and maintain the MedDRA synonym list
    • Lead WHO Drug Dictionary Updates coordinating with Safety Systems and Clinical as required
    • Coding Conventions Creation Review
    • Maintenance of Library of SMQs
    • Generation and review of weekly reports to support MedDRA Coding
    • Within the clinical space in collaboration, develop coding conventions required across safety and Clinical databases and develop coding conventions and associated reports to support oversight and consistency of coding for clinical trials where necessary supporting trial specific coding strategy
    • Manage the Product Dictionary (including labeling information)
    • Assist with coding efforts associated with Clinical Study Report, ISS & 120 day updates
    • Develop thorough appreciation of data analysis needs and translate to coding convention approaches
    • Execute auto-batch update of terms when necessary
    • Liaise with Lead Product Safety Physician to establish EOI search strategies
    • Maintain EOIs/Search Strategies and update as needed following semi-annual MedDRA upgrades in accordance with MSSO updates and in collaboration with Safety Systems
    • Manage the communication of key coding synonym list changes to applicable stakeholders
    • Support deployment of medical coding process by close cooperation with relevant functions
    • Provide training, support, and coaching as required
    • Provide Feedback to stakeholders regarding improper coding for AEs that require a PT change
    • Feedback/changes to all other data fields including AEs that do not require a PT change, MHIs, Indication, and lab terms
    • Contribute to RAVE Clinical coding and pooled data review
    • Support Company Product Dictionary update in accordance with Safety Systems
    • Attend PSUR search strategy meetings and input into aggregate report strategy with respect to Medical Coding developing strategy in collaboration with Safety Physicians
    • Support product and class specific coding strategy as required in accordance with Safety Physicians to enable search strategies supporting strategy and requirements associated benefit risk assessment and regulatory commitments including maintaining lists of terms of Special Circumstances in accordance with Medical Review Group strategy
    • Define Medical Coding Community of Practice (COP), including roles, operating mechanisms, communication strategies, and levels of training and access
    • Chair a coding group drawing representation from across the and external functions as required to ensure that coding practices meet business need in alignment with applicable regulatory process and mandates
    • Manage Client's interaction with the MedDRA MSSO and all associated change requests
    • Responsible for ensuring that all pre and post MedDRA upgrade tasks are completed
    • Facilitate effective co-ordination around MedDRA understanding & utilization across relevant Client groups and provide training on medical coding and WHO DD as required to staff and BPO
    • Ensure effective liaison and consistency in the use of MedDRA across Client focusing on both Staff and BPO as appropriate
    • Responsible for all aspects related to code change requests for Client
    • Liaise with Leadership Team, Therapeutic Area Heads, MRSPs, Aggregate Reports, Clinical and other functional leaders to ensure consistency of Medical coding practice and strategy
    • Establish and Maintain a Medical Coding Community of Practice 
    • Provide leadership, coaching and training  including both the technical processes and the behaviors necessary to optimize process Medical Coding execution
    • Define process monitoring methods, including data collection and analysis, metrics, and associated targets, and reporting mechanisms including quality, compliance and process effectiveness aspects
    • Support the organization during regulatory inspections or audits, which may include direct interface with inspectors/auditors and writing/reviewing responses
    • Collaborate with Cross-functional stakeholders and SMEs to drive optimal execution of process across Client and external partners as appropriate
    • Support or manage high-priority, cross-functional events
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
June Binuya
June Binuya | LinkedIn

Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. 

Application Instructions

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