Novartis Life Sciences Clinical Scientific Expert – I Recruitment

900! That is the approximate number of individual regulatory documents the dynamic team at Regulatory Writing and Submissions (RWS) planned, developed and wrote. And that’s just in 2019! Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians and project managers across 6 countries and support Novartis in its mission to bring innovative medicines to patients worldwide. You will collaborate with colleagues from Statistics, Data Management and Clinical Development and have the opportunity to analyze data and derive key messaging to secure approvals from Health Authorities. Read on for details about the role and how you can join a world-class organization at the forefront

of the industry to advance your career.

Your responsibilities include, but are not limited to

• Responsibility for ensuring high quality clinical trial data review/insights and analysis as advised by the Integrated Clinical Trial Team (iCTT)
• Perform high quality clinical data review and identify clinical data insights through patient level review and trends analysis, supporting Interim Analysis, Database and Post Lock activities and facilitate resolution of clinical data issues.
• Collaborate with relevant line functions to improve the quality of clinical data review/insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review.
• Chips in to the development the Data Review/Quality Plan (DRP/DQP) and data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study.
• In conjunction with the relevant line functions, may supply to Case Report Form (CRF) development, and support the implementation of data capture tools.
• Chip in to and facilitate data review process improvements e.g. identification of delinquent/redundant reports and/or implementation of innovative data analysis processes and tools.
• May supply (in collaboration with relevant line functions) to the development of study-level documents, including clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers. In collaboration with relevant line functions, review/write clinical trial documents for study CSR activities, and publications.
• May support pharmacovigilance activities (e.g., reviewing/chipping in to aggregate reports/patient narratives, attendance of Safety Monitoring Meetings (SMT)), if required. Produce training materials and provide training to iCTT.

Minimum requirements –

• A sophisticated degree in life sciences/healthcare (or clinically relevant degree) is required. PhD, MBBS, BDS, MD are strongly preferable. Proficient English (oral and written).
• > 1-year of experience in the Pharmaceutical industry/ clinical research organization. Basic knowledge in planning, executing, reporting and publishing global clinical studies in a pharmaceutical company or contract research organization.
• Work experience in clinical operations is preferable. Strong social skills – Ability to work under pressure. Good negotiation and conflict resolution skills. Collaborates across boundaries for shared success
• Resolve issues with minimal direction and understands when to raise. Fundamental knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process
• Strong analytical/computational background. Demonstrates strong Medical / scientific writing skills. Demonstrates knowledge and application of statistical analysis methodology and can identify trends and analyze/interpret / report data optimally.

APPLY ONLINE

Editor’s Note: Novartis Clinical Scientific Expert Job Opening, Apply Online. Please make sure that you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of all of the latest in the industry. Follow us on our social media like Twitter, Telegram, Facebook and Instagram.