Associate Director, Medical Coding - GCO Clinical Data Management

Role Summary

The Associate Director, Medical Coding is responsible to plan, lead, manage and oversee the medical coding infrastructure and activities of Teva’s development programs across all indications from Phase I to Phase IV, in terms of cost, quality, timeliness and efficiency, while assuring patient safety and data quality and integrity.

Responsibilities

• Leads, manages, and oversees activities related to the delivery of complete, accurate and consistent medical coding for all supported clinical trials for reporting and analysis.
• Supervises direct reports who are responsible to lead and manage and provide oversight of coding tasks performed by outsourced service providers to ensure milestones, deliverables, quality, and timelines are met.
• Ensures all coding activities and deliverables for all studies are completed in line with business requirements, company objectives, within budget and in accordance with regulatory requirements.
• Develops and maintains related processes, guidelines and conventions and coding infrastructures.
• Develops and maintains coding infrastructure for both internal and external coding model to provide coding and oversight activities, including administration of relevant internal coding systems where applicable.
• Develops and maintains internal coding reports to assist in providing coding oversight reviews and consistency checks for quality coding deliverables.
• Develops, maintains, and ensures compliance of global coding MedDRA and WHODrug coding conventions to promote consistency, accuracy, and quality coding. Ensures relevant training and ongoing support to internal and external coding teams.
• Leads the department development of SOPs, procedural documentation, and continuous process improvement in collaboration with Strategic Planning and Process Management and relevant stakeholders.
• Identifies areas for innovation and potential supporting technologies.
• Acts as Business Owner and Point of Contact for Company Global MedDRA and WHODrug dictionary licenses, renewals, budgets, and relevant user access to dictionary files.
• Maintains and develops dictionary version implementation plans for supported clinical development studies and the integrated clinical safety database, as necessary, in accordance with SOPs, guidelines and standard conventions.
• Supports collaboration, communication, coordination, and prioritization within the department, across the organization, and with services partners.
• Leads initiatives and represents GCO/Data Management as a key stakeholder in global cross-functional initiatives.
• Recruits, selects, develops, trains, manages, motivates, coaches, and appraises the performance of direct reports. Builds team commitment to goals and creates a positive and productive culture within the team.
• Follows Teva Safety, Health, and Environmental policies and procedures.
• Performs other duties as requested by management and conducts special projects as assigned.

Qualifications

• Required: Bachelor or higher degree in science or PharmD with medical/clinical experience (candidates with lesser education may qualify if experience and demonstrated skills are commensurate).
• Required: 10+ years of medical coding experience in a pharmaceutical or clinical research setting.
• Required: Strong management and supervisory experience in a global setting, medical coding environment within the pharmaceutical industry.
• Preferred: Well versed in trends and emerging industry dynamics concerning coding in the pharmaceutical industry.
• Preferred: Expert knowledge of coding dictionaries, coding applications and industry standards, including but not limited to: MedDRA, WHODrug, SMQs, SDGs, MVAT, CAT, WHODrug Insight, MedDRA Web-based browser.
• Preferred: Working knowledge of various coding systems applications, including but not limited to Rave Coder, Veeva Vault, TMS, etc.
• Required: Extensive knowledge of GCPs and ICH guidelines.
• Preferred: Strong experience in vendor and CRO management in the pharmaceutical industry.
• Preferred: Experience in process improvement and design as well as project management and budget expertise.
• Preferred: Good Information Technologies orientation.
• Required: Excellent written and oral communication skills.
• Preferred: Proven success working in a virtual, global, and multi-cultural environment.

Skills

• MedDRA, WHODrug, SMQs, SDGs, MVAT, CAT, WHODrug Insight, MedDRA Web-based browser
• Rave Coder, Veeva Vault, TMS
• GCPs and ICH guidelines
• Vendor and CRO management
• Process improvement and design
• Project management and budgeting
• Information Technologies orientation
• Excellent written and oral communication
• Ability to work effectively in a virtual, global, and multi-cultural environment

Education

• Bachelor or higher degree in science or PharmD with medical/clinical experience