Bristol-Myers Squibb Company

Clinical Coding Terminology Administrator

Location
Princeton, NJ, US
Posted
May 12, 2018
Ref
R1121657
Required Education
Bachelors Degree
Position Type
Full time
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.

Establish and enforce the versioning strategy and timeline for routine version updates for industry standard terminologies (MedDRA, UMC WHO-Drug). Develop and maintain coding guidelines for MedDRA and UMC WHO-Drug based upon industry best practice documents. Oversight of the review and approvals of reported terms in clinical trials designated for MedDRA and UMC WHO-Drug. Ensures that the coding is clear, appropriate and complete as per investigator's entry on the CRF based on compliance with SOP and Coding Guidelines. Qualitative analysis which ensures the consistency and accuracy of coding at the protocol, project and synonym table. Develop and maintain coding related business process documents.

Knowledge of general clinical research, data management, and of the pharmaceutical industry. Thorough understanding of regulations, GCP, ICH Guidelines as they apply to coding of medical terminology.

• Minimum of 7-10 years coding in clinical research and of the pharmaceutical industry

• Knowledge equivalent to that attained with a Bachelor's degree in the Life Sciences

• Experience with hierarchical reporting dictionaries; MedDRA and UMC WHO-Drug.

• Thorough understanding of the of MedDRA and UMC WHO-Drug Dictionary hierarchy and structure

• Complete understanding of the construction, versioning and maintenance of MedDRA company Standardized MedDRA Queries (SMQs)

• Complete understanding of MedDRA Points to Consider and the application of PTC in company coding guidelines and conventions

• 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 understanding of the construction, versioning and maintenance of UMC WHO-Drug company Standardized Drug Groupings (SDGs).

Kn Knowledge or experience using TMS 4.6.1, TMS 5.1, Oracle Clinical, Rave, Rave Coder, J-Review