Novartis

Perform and document scientific experiments in the laboratory for drug substances and drug products in collaboration with multifunctional project teams. Contribute to maintenance of lab instruments / day-to-day operations.

Principal Clinical Data Standards Specialist is responsible for the development, maintenance and implementation of Industry CDISC and regulatory compliant Clinical Data Standards, providing expert support to business users and teams on their use in line with the Clinical Data Standards strategy.

Develop business plans and implement related activities like customer events, sales & marketing campaigns, sales presentations necessary to achieve agreed objectives.

Contributes and support the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports.

Supplier qualification: Ensures a valid Quality Agreement in line with the requirements of the Novartis global template is in place and continuously amended to the business needs.

BTech / Masters in Technology or Masters in Business Administration. The Execution QA comprehensively reviews rendering quality, Metadata, Content Matrices. Novartis

Working in partnership with the Client Engagement team, Medical Communications, and the Writing delivery team for a designated client group/therapeutic area (TA) / brand, this role will be responsible for delivering and supporting scientific excellence of Medical Communications services across their accounts

Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation and publication of REG CMC documentation for submissions to Health Authorities.

Designs and coordinates the overall direction of clinical development projects. Coordinates activities of associates and investigators to ensure compliance with protocol and overall pre-clinical objectives. Maintains a high level of professional expertise through familiarity with clinical literature and participates in project team meetings