Novartis

M.Sc., M Pharm. B.Sc. Prepares / supports the preparation of highly complex scientific documents to meet highest quality standards. Initiates, implements and champions process improvement techniques.

Deliver non-interventional studies, research collaborations, and investigator-initiated trials, managing spend and forecasts. Represent Study Management operations at Therapy Area Medical Affairs Team meetings.

Support initiatives to maintain or improve quality performance and compliance of Novartis PV activities including case processing, medical safety, risk management, Health Authority reporting, PV IT systems and device vigilance. Champion the quality mindset.

Minimum Bachelors degree in Life Sciences or Pharmaceutical Sciences required. Masters / other advanced degree or MBA in business administration or a scientific field preferred.

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.