MedDRA/WHO Drug Coding SME - Clinical Data Quality Lead

Fortrea; United States; Remote; USD 100,000 - 165,000; Full time

Job summary

Fortrea is seeking a Medical Coding SME to ensure high-quality, consistent coded clinical data across multicenter studies. You’ll partner with Clinical Data Management and global stakeholders to align coding across programs.

You’ll lead MedDRA and WHO Drug dictionary upversioning, oversee third‑party coding activities, and identify opportunities for improvement. Requires 5+ years of Medical Coding experience in pharma, biotech or CRO, with fluent English.

Qualifications

• 5+ years of medical coding experience using MedDRA and WHO Drug.
• 5+ years within pharma, biotech, or CRO environments.
• Bachelor’s degree in Life Sciences, Nursing, Biology, Health Sciences, or related field.
• Strong understanding of Clinical Data Management and ICH/GCP.
• Experience reviewing coded clinical data and resolving quality or consistency issues.
• Fluent English and strong communication skills.

Responsibilities

• Serve as a Medical Coding SME across clinical development studies.
• Review coding quality and consistency using MedDRA and WHO Drug.
• Provide oversight and quality review of third-party coding activities.
• Lead MedDRA and WHO Drug dictionary upversioning.
• Identify coding issues, trends, and opportunities for continuous improvement.
• Partner with Clinical Data Management and cross-functional teams on coding standards and conventions.

Skills

Medical Coding

MedDRA

WHO Drug

Clinical Data Management

ICH/GCP

English fluency

Education

Bachelor's degree in Life Sciences

Tools

Veeva

Medidata RAVE Coder

Elluminate

CORE

Job description

Fortrea is seeking a Medical Coding SME to ensure high-quality, consistent coded clinical data across multicenter studies. You’ll partner with Clinical Data Management and global stakeholders to align coding across programs.

You’ll lead MedDRA and WHO Drug dictionary upversioning, oversee third‑party coding activities, and identify opportunities for improvement. Requires 5+ years of Medical Coding experience in pharma, biotech or CRO, with fluent English.