Senior Medical Coding Specialist – Sponsor Dedicated

About the role

The Senior Medical Coding Specialist works within a sponsor‑dedicated model, partnering with sponsor stakeholders and cross‑functional clinical data management teams to provide medical coding expertise, oversight, and quality review across clinical development studies. This position acts as the Medical Coding Subject Matter Expert (SME) ensuring consistent, high‑quality coded clinical data using MedDRA and WHO Drug dictionaries.

Key responsibilities

• Provide technical expertise on medical coding, dictionary management and coding quality.
• Independently review clinical data coded by third parties and oversee outsourced coding activities.
• Identify and communicate coding quality issues, propose solutions and support sponsor‑level decisions.
• Maintain and update coding guidance, training documentation and study‑specific conventions.
• Manage MedDRA and WHO Drug Dictionary up‑version activities across studies.
• Collaborate with Clinical Data Management and other functions to ensure consistent handling of coded data.
• Monitor coding quality metrics, contribute to continuous‑improvement initiatives and process standardisation.

Required profile

• Bachelor’s degree in Nursing, Biology, Life Sciences, Health Sciences or related field.
• 5+ years of medical coding experience using MedDRA and WHO Drug dictionaries in pharma/biotech or CRO settings.
• Strong knowledge of ICH/GCP guidelines, regulatory requirements and clinical data management processes.
• Excellent written and verbal English communication skills.
• Ability to work independently, manage multiple priorities and collaborate globally.

Required skills

• MedDRA and WHO Drug Dictionary expertise.
• Clinical coding applications (e.g., Veeva, Medidata RAVE Coder).
• Clinical data warehouse tools (Elluminate, CORE).
• Proficiency with Microsoft Office suite.
• Understanding of coding best‑practice documentation and up‑versioning procedures.