Senior Medical Coding Specialist | Sponsor-Dedicated

About the role

The Senior Medical Coding Specialist will work within a sponsor-dedicated model, partnering closely with sponsor stakeholders and cross-functional clinical data management teams to provide medical coding expertise, oversight, and quality review across clinical development studies.

This role serves as a Medical Coding Subject Matter Expert (SME) responsible for ensuring the quality and consistency of coded clinical data using MedDRA and WHO Drug dictionaries. The position provides independent review of coding performed by third parties, supports oversight of outsourced medical coding activities, manages dictionary upversion activities, and provides guidance on dictionary use and coding quality.

The Senior Manager, Medical Coding will collaborate with Clinical Data Management and other relevant functions to support high-quality, compliant medical coding practices in accordance with applicable regulations, industry standards, coding guidelines, and study requirements.

Summary of Responsibilities

• Serve as a Medical Coding SME, providing technical expertise and guidance related to medical coding, dictionary management, and coding quality.
• Perform independent review of clinical data coded by third parties to ensure consistent and high-quality coding.
• Support oversight of outsourced medical coding activities through medical coding review and synonym dictionary review.
• Review coding outputs and proactively identify coding quality issues, inconsistencies, or areas requiring further evaluation.
• Review and maintain guidance and training documentation supporting coding conventions and guidelines in accordance with applicable ICH guidelines, coding standards, and dictionary definitions.
• Identify and communicate medical coding issues requiring sponsor-level decisions and provide proposed solutions, as appropriate.
• Provide support and subject matter expertise to other functions regarding dictionary use and coding quality.
• Collaborate with Clinical Data Management and other cross-functional stakeholders on the creation, review, and maintenance of documents referencing medical coding activities.
• Support and manage MedDRA and WHO Drug Dictionary up version activities across applicable studies, including studies where coding activities are performed by third parties.
• Support the development, review, and application of study-specific coding conventions and specifications, as applicable.
• Collaborate with relevant clinical development functions to promote consistent and cohesive handling of coded clinical data.
• Monitor medical coding quality and contribute to applicable metrics, trend identification, and continuous improvement activities.
• Identify potential coding process improvements and contribute to implementation of effective, standardized practices.
• Ensure medical coding activities are conducted in compliance with applicable industry quality standards, regulations, guidelines, and procedures.
• Maintain current technical expertise through applicable training and awareness of evolving medical coding practices, terminology dictionaries, and industry guidance.
• Participate in process improvement activities and other medical coding initiatives as assigned.

Qualifications (Minimum Required)

• Bachelor's degree in Nursing, Biology, Life Sciences, Health Sciences, or another health-related discipline.
• Fluent in English, both written and verbal.
• Strong written and verbal communication skills.
• Strong attention to detail with demonstrated prioritization, planning, organizational, and multitasking skills.
• Ability to collaborate effectively within global and cross-functional teams.

Experience (Minimum Required)

• 5+ years of medical coding experience using MedDRA and WHO Drug dictionaries.
• 5+ years of experience within the pharmaceutical, biotechnology, and/or CRO environment.
• Strong knowledge of medical coding processes and standardized medical coding dictionaries.
• Working knowledge of MedDRA and WHO Drug best practice documentation.
• Knowledge of ICH/GCP guidelines and methodology and applicable regulatory requirements.
• Good understanding of Clinical Data Management processes and their relationship with medical coding activities.
• Experience reviewing coded clinical data and identifying coding quality or consistency issues.
• Ability to provide technical guidance and collaborate effectively with Clinical Data Management and other clinical development stakeholders.
• Strong analytical and problem-solving skills with the ability to evaluate coding issues and propose appropriate solutions.
• Ability to work independently and manage multiple priorities within a global clinical development environment.
• Proficiency with Microsoft Office applications.

Preferred Qualifications Include

• Experience with clinical coding applications. Veeva and Medidata RAVE Coder experience is desirable.
• Experience with clinical data warehouse tools such as Elluminate and CORE.
• Experience overseeing or reviewing medical coding activities performed by third-party providers or CRO teams.
• Experience with MedDRA and WHO Drug Dictionary upversioning.
• Experience developing, reviewing, or maintaining coding conventions, guidance, or training documentation.
• MedDRA certification or equivalent advanced medical coding training is preferred.

Physical Demands/Work Environment

• Office and/or home-based work environment, as applicable.
• Ability to collaborate effectively within global, virtual, and cross-functional teams.

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