Associate Director, Medical Coding - GCO Clinical Data Management

Overview

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. We’re dedicated to addressing patients’ needs now and in the future. You’ll be part of a high-performing, inclusive culture that values fresh thinking and collaboration, with room to grow, flexibility to balance life with work, and the opportunity to improve health worldwide, together.

The Associate Director, Medical Coding is responsible for planning, leading, managing and overseeing 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.

Essential Duties & 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 lead and manage or 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 models 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.

Any equivalent combination of education, training, and/or experience that fulfills the requirements of the position will be considered.

• Education Required:
  
  Bachelor or higher degree in science or Pharm
  
  D with medical/clinical experience is required. Candidates with lesser education may qualify if experience and demonstrated skills are commensurate.
• Experience
  
  Required:
  
  Associate Director must have 10 or more years of medical coding experience in a pharmaceutical or clinical research setting. Strong management and supervisory experience in a global setting, medical coding environment within the pharmaceutical industry.
• Well versed in trends and emerging industry dynamics concerning coding in the pharmaceutical industry.
• Expert knowledge of coding dictionaries,…