Job Title: Medical Coding Specialist II
Location: United States (Remote)
About ICON plc: ICON plc is the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence.
Responsibilities:
Provide independent review of data coded by third parties ensuring consistent coding.
Oversee work outsourced to CROs through medical coding review and synonym dictionaries review.
Participate in the review and maintenance of guidance and training documentation for coding guidelines in accordance with ICH guidelines, client coding guidelines, and dictionary definitions.
Communicate issues to client medical coding leadership that require decision-making, including proposals for solutions.
Provide support to other departments concerning dictionary use and coding quality.
Collaborate on the creation and maintenance of CDM documents referencing coding-related activities.
Support and manage MedDRA and WHO Drug Dictionary upversion activities for both client and third-party vendor-operated studies.
Ensure compliance with industry quality standards, regulations, guidelines, and procedures.
Qualifications:
A degree in nursing, biology, or a health-related field.
5+ years of experience in medical coding using MedDRA and WHO Drug Dictionaries.
5+ years in the Pharmaceutical/Biotechnology industry or a CRO environment.
Knowledge of ICH/GCP guidelines and methodology.
Excellent verbal and written communication skills.
Detail-oriented with the ability to multitask, prioritize, plan, and organize tasks.
Strong team player.
Proficiency in Microsoft Office Applications.
Working knowledge of MedDRA and WHO Drug best practice documents.
Experience with coding applications (Veeva, Medidata RAVE Coder) desirable.
Experience with data warehouse tools (e.g., Elluminate, CORE).
Good understanding of Clinical Data Management processes and applicable regulatory requirements.
What ICON can offer you:
Competitive salary and benefits focusing on well-being and work-life balance.
Various annual leave entitlements and health insurance options for you and your family.
Competitive retirement planning offerings to maximize savings for the future.
Access to the Global Employee Assistance Programme (TELUS Health), offering 24-hour support.
Life assurance and flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, and discounted gym memberships.
At ICON, inclusion & belonging are fundamental to our culture and values. We are committed to providing an environment free from discrimination and harassment.
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