Senior Manager Coding

Role & responsibilities

• Implement medical coding strategy and execute operational plans in alignment with Data Management objectives, regulatory requirements, and organizational priorities.
• Ensure accurate, consistent, and timely coding of clinical data utilizing MedDRA and WHODrug dictionaries in accordance with company standards, study-specific conventions, and regulatory requirements.
• Provide oversight of medical coding activities performed by internal staff and CRO partners, including coding study setup, user acceptance testing (UAT), coding assignments, query management, synonym management, SAE reconciliation, and review of coding deliverables.
• Perform and review medical coding activities, as needed, to support high-priority studies, complex coding scenarios, quality reviews, and issue resolution.
• Develop, maintain, and ensure consistent application of therapeutic area and study-specific coding conventions.
• Support the creation and maintenance of search groupings (e.g., SMQs, CMQs, FMQs, SDGs, CDGs) to facilitate identification of adverse events of special interest (AESIs) and prohibited medications.
• Monitor coding quality, timelines, metrics, and key performance indicators, implementing actions to address risks, issues, and opportunities for improvement.
• Oversee implementation, maintenance, and governance of MedDRA and WHODrug dictionaries across clinical studies, including version upgrades, impact assessments, change control, and maintenance of source files.
• Assess operational and regulatory impacts of dictionary updates and coordinate recoding activities as appropriate.

Preferred candidate profile

• Minimum of 8+ years of experience in biotechnology, pharmaceutical, or health-related industry including at least 5-7 years of direct Medical Coding
• experience. Minimum of 3 years of people management experience is required.
• Demonstrated experience leading Medical Coding teams and coding operations is strongly preferred.