CISR Committee Lead

Your responsibilities will include;

• Manages C-ISRC Review process for approximately 100+ clinical documents each year
• Ensures appropriate C-ISRC documentation and meeting management
• Assists in the development of high-quality protocols and other clinical documents via addressing C-ISRC processes/workflow related questions, and training and guidance as appropriate
• Works with various systems and trackers to ensure smooth C-ISRC workflow (includes CAT, Please Review, Document Management System, etc.); may work on system improvement as appropriate
• Serves as back-up to fellow C-ISRC Leads and may attend C-ISRC meetings to take minutes or co-facilitate the sessions
• Manages timely key data entry to create reports from appropriate systems and facilitate tracking of key metrics for the C-ISRC Office
• May assist in audits and inspection readiness as needed/related to C-ISRC process/documentation
• Supports other C-ISRC and Clinical Development projects and activities as appropriate (e.g. updating guidance, contributing to trainings and best practice sharing, etc.)

Minimum requirements

• Minimum Bachelor’s degree in science; Advanced degree, or equivalent, in science or healthcare preferred.
• 5+ years’ experience in pharmaceutical industry
• Strong knowledge of clinical drug development process, including trial design, GCP, regulatory processes, and clinical project management
• Working knowledge of IT systems and trackers, including Document Management System
• Excellent interpersonal, communication, presentation and meeting management skills
• Advanced medical/scientific writing and communication skills
• Ability to influence wide variety of stakeholders in a matrix environment.

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.