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Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: careers.bms.com/working-with-us .
BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.
Functional Area Description
Global Development Operations (GDO) is accountable for the execution and management of R&D development studies. Global Data Management and Centralized Monitoring (GDMCM) is accountable for the data capture, integration, review, quality, and governance for studies spanning the R&D Portfolio
Position Summary / Objective
Clinical Research Associate Director, Medical Coding will be responsible for the management of industry standard terminologies (MedDRA, UMC WHODrug) along with the oversight of coding for major projects or programs. Drives the update and development of coding guidelines and versioning related activities. Responsible for the development and refinement of medical coding processes and procedures.
This role reports to the Director, Medical Coding
Position Responsibilities
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Responsible for delivering accurate and consistent medical coding for all assigned protocols within established timelines and in compliance with all processes, guidelines, and conventions.
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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.
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Establishes and maintains communications between safety, clinical and vendors to ensure MedDRA mapping consistency between AWARE, TMS and CRO systems.
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Support maintenance activities for coding tools, including User Acceptance Testing (UAT) including script creation and execution.
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Perform periodic review of industry best practices and coordinate the review and updating of BMS guidelines to ensure alignment.
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Assist with the development of Medical Coding best practices, SOPs and coding process documents.
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Creating and maintaining company specific Standardized MedDRA Queries and company specific standardized drug groupings in partnership with medical, clinical, and other key functions.
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Provide ad hoc medical coding expertise in support of regulatory activities (e.g., periodic safety updates, submissions, etc.).
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Ensure effective quality oversight and management of external partners (e.g., Functional Service Providers, CROs, etc.) performing medical coding services on behalf of BMS.
(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)
Degree Requirements
Bachelor’s degree in the Life Sciences, RN, or RPh.
Experience Requirements
Minimum of 7 years relevant industry experience.
Key Competency Requirements
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Experience with hierarchical dictionary reporting dictionaries; MedDRA and UMC WHODrug.
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Thorough understanding of versioning of MedDRA and UMC WHODrug
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Complete understanding of the construction, versioning, and maintenance of MedDRA and Standardized MedDRA Queries (SMQs)
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Complete understanding of the construction, versioning, and maintenance of UMC WHODrug and Standardized Drug Groupings (SDGs)
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Thorough understanding of regulations, GCP, ICH Guidelines as they apply to coding of medical terminology.
#HYDDD #LI-Hybrid
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected] . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol Myers Squibb
Req Number: R1571215
Updated: 2023-07-20 03:59:43.652 UTC
Location: Hyderabad,India
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
