Associate Medical Coding Director – Biotechnology Oncology

Associate Medical Coding Director – Biotechnology Oncology

Requirements

• BS/BA degree with related health science background (e.g. Nursing, Pharmacy) and a minimum of 11 years of related experience; or,
• MS/MA degree with related health science background (e.g. Nursing, Pharmacy) and a minimum of 9 years of related experience; or,
• PhD in related discipline and a minimum of 5 years of related experience, or;
• Equivalent combination of education and experience.
• May require certification in assigned area.
• 10+ years of related experience and/or combination of experience and education/training.
• 10+ years of pharmaceutical/biotechnology/CRO in Medical Dictionary Coding, Clinical Data Management and project management.
• Advanced knowledge of ICH-GCP guidelines and applicable drug development regulations.
• Strong understanding of drug development and clinical trial execution, including other required functional areas involved in clinical trials.
• Must have a strong understanding and utilization of medical terminology.
• Experience in coding medical data (adverse events and concomitant medications) and understanding of the clinical coding process is required. Working knowledge of MedDRA, and WHODrug is strongly required.
• Experience with Clinical trial data systems and/or EDC coding tools is required with Medidata Coder experience preferred.

Responsibilities

• Provides and enables solutions for complex problem solving that align with the Exelixis values.
• Establishes Program(s) or Portfolio level dictionary coding strategies and is accountable for the management of vendor partnerships to maximize effectiveness and maintain budgets.
• Leads clinical trial coding deliverables and activities that support Exelixis regulatory commitments including submission of safety data.
• Provides coding expertise and capability in support of global development programs.
• Serves as a medical coding subject matter expert within Exelixis.
• Partners with stakeholders including CDM Systems and Digital Transformation to optimize technology that supports efficient dictionary management processes and with Global Patient Safety and Clinical Development for oversight of vendor coding quality.
• Develops and maintains Exelixis coding conventions to ensure consistency across studies and programs.
• Reviews program and study-level clinical trials, serious adverse events (SAE), concomitant medications, and other relevant coded data performed by vendors for quality and consistency.

Preferred Qualifications

• Ability to prioritize and multi-task successfully in a fast-paced and changing environment.
• Excellent interpersonal and communication skills, both written and oral, including ability to develop strong relationships with internal and external stakeholders.
• Excellent organizational skills with strong attention to detail; proven ability to handle multiple tasks efficiently, effectively, and timely.
• Demonstrated ability to think strategically across the organization.
• Self-motivated, calm under pressure and adaptable to a dynamic environment with the ability to support successful change.
• Must be detail-oriented with the ability to handle multiple projects and priorities.
• Demonstrates effective interpersonal and communication skills.
• Ability to contribute to the definition and timely achievement of area projects and goals and serve as a representative for Coding on cross functional projects.
• Problem solving skills should involve identification of problems and proper escalation.
• Must be able to work independently as well as in a team environment and effectively collaborate with stakeholders for effective outcomes.