Novartis Pharmaceuticals Hiring for Principal Coding Specialist at Hyderabad, AP, India Full Time

370851BR Job ID: 370851BR Job Description: 50 Plus global studies will be the magnitude of the function to which you will be partnering as a team member. Within the Biometrics function you will be playing a key role in taking the accountability and delivering studies end to end of Data Management solutions. Will get opportunity to work on varied clinical studies of all phases which includes Interventional, Non- Interventional, Chart review, Observational, Prospective & Retrospective studies across all therapeutic areas. At Novartis NBS CONEXTS we aim to provide innovative solutions to help Novartis medical and scientific teams re-imagine medicine, Delivering cost effective and scalable competitive solutions through focus on productivity, Building assets and competitive Novartis solutions, enhancing innovation and our unique service offering, Providing leading edge quality and innovation through our expert global workforce. Your key responsibilities: Your responsibilities include, but not limited to: • Ensures that Clinical Coding is performed at a consistently high standard in the Therapeutic Area. Ensures that the Coding related sections of the Data Management Documents are updated and Coding is complete and reviewed in support of all timelines/deliverables. • Performs accurate/consistent review of coding done by coding team (ESP) in alignment with, standard coding conventions. Approves synonym list, review coding related queries, interact with different stakeholders in order to answer coding related questions. • Specific responsibility of Leading/managing synonym review/update processes and Dictionary version upgrades at trials/project level. Review coding related SOP, WP; attend various discussion forums as a coding SME. • Troubleshoots coding problems, collaborating with peers, database developers, and/or IT support as needed Effectively represents the Coding in the CTT meetings or in communications with the stakeholders. Coach, mentor and develop the new joiners technically, may serve as an SME for Coding. • Ensure complete and consistent medical term coding using appropriate standard dictionaries; ensure consistency of serious adverse event data across clinical and drug safety databases. Ensure up-to-date and accurate tracking of report status and progress of medical coding activities for allocated trials and be proactive to ensure smooth and successful timely locking of databases. • Ensure timely completion of coding related document archiving; as necessary; respond to Health Authority/FDA/audit requests pertaining to project-specific coding issues. Participate in the development of a Data Management organization through his/her leadership role within the DM Group for Data Sciences. • Participate in clinical & non-clinical special projects. May assist in hiring, coaching, training, and mentoring of other Data Management staff. nnnn Position Title: Principal Coding Specialist Minimum requirements: Minimum Requirements: • 8 or more years of experience in drug development with at least 6 years performing Clinical coding activities (end to end) and good understanding of data management activities • Experience in managing outsourced studies or working for a CRO. Demonstrated ability to adapt to different coding technologies • Expert level of knowledge of medical terminology, including medical conditions and medications • Project management skills .Strong attention to detail. • Strong verbal and written communication skills, including ability to author Coding conventions, SOPs/WPs, and training materials • Ability to work independently, under pressure, and in an environment where flexibility is required. • Understanding of clinical trials methodology, GCP, system validation requirements, and coding tools. Why Novartis? 769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network. Job Type: Full Time Country: India Work Location: Hyderabad, AP Functional Area: Research & Development Division: Operations Business Unit: CONEXTS Employment Type: Regular Company/Legal Entity: Nov Hltcr Shared Services Ind Commitment to Diversity & Inclusion:: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Shift Work: No Early Talent: No