Job Description

At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Summary

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.

Full Description

Responsible for delivering accurate and consistency 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 investigators 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).

Assist in maintenance activities for coding tools, including User Acceptance Testing (UAT) script creation and execution.

Perform periodic review of industry best practices and BMS coding guidelines to ensure alignment.

Assist with development and update of Medical Encoding best practices, SOPs and coding process documents.

Assist with the development; creation and maintenance of company specific Standardized MedDRA Queries.

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.

Must Have Requirements

Bachelor's degree required

Minimum of 5-7 years coding in clinical research and of the pharmaceutical industry

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.

Role requires the candidate to be local to the Princeton, NJ area and onsite 3 days a week. This position does not allow for full remote work.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.