Associate Director, Medical Coding
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
Seeking an experienced Clinical Research encoding specialist to be responsible for the management of industry standard terminologies (MedDRA, UMC WHO-Drug) along with the oversight of coding for major project or programs.
- Responsible for delivering accurate and consistent medical coding for all assigned protocols within established timelines and in compliance with all processes, guidelines and conventions.
- Oversight of the review and approval of coded terms in clinical trials designated for coding with MedDRA ensuring that coding is clear, appropriate and complete based upon the investigator's entry on the CRF and in compliance with all processes, guidelines and conventions.
- Establishes and maintains communications between GPV&E, clinical and vendors to ensure MedDRA mapping consistency between AWARE, TMS and CRO systems.
- Establish and enforce the versioning strategy and timeline for routine version updates for industry standard dictionaries (MedDRA, UMC WHO-Drug).
- Support maintenance activities for coding tools, including User Acceptance Testing (UAT) script creation and execution.
- Perform periodic review of industry best practices and coordinate the review and updating of BMS coding guidelines to ensure alignment.
- Assist with development and update of Medical Encoding best practices, SOPs and coding process documents.
- Creating and maintaining company specific Standardized MedDRA Queries and company specific Standardized Drug Groupings in partnership with medial and clinical data reporting and analytics functions.
- Provide ad hoc medical coding expertise in support of regulatory activities (e.g. periodic safety updates, submissions, etc.).
- Ensure effective quality oversight and management of external partners (e.g. Functional Service Providers, CROs, etc.) performing medical coding services on behalf of BMS.
- Knowledge of general clinical research and of the pharmaceutical industry. Thorough understanding of Regulations, GCP, ICH Guidelines as they apply to coding of medical terminology.
- Minimum of 7 years relevant industry experience.
- Bachelor's degree in the Life Sciences, RN, or RPh
- Experience with hierarchical dictionary reporting dictionaries; MedDRA and UMC WHO-Drug.
- Thorough understanding of the versioning of MedDRA and UMC WHO-Drug
- Complete understand of the construction, versioning and maintenance of MedDRA company Standardized MedDRA Queries (SMQs)
- Understanding of medical concepts, biology and chemistry in support of medical encoding
- Thorough understanding of regulations, GCP, ICH Guidelines as they apply to coding of medical terminology.
- Complete understand of the construction, versioning and maintenance of UMC WHO-Drug company Standardized Drug Groupings (SDGs)
Ideal Candidates Would Also Have:
- Experience with encoding computer systems: Oracle Clinical, Thesaurus Management System (TMS), dsNavigator, or Medidata Rave and/or Coder.