CISR Committee Lead (Senior Project Coordinator)

About the Opportunity

When we put our heads together, we can do brilliant work. And when we do brilliant work, we can achieve remarkable things for patients as we positively transform healthcare. We are looking for a Central Integrated Scientific Review Committee Lead. This is a Senior Project Coordinator level role.

Responsibilities

• 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.)

About You

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.

Eligibility

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Novartis Life Handbook. 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.

About Company

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? Novartis People and Culture.

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