May 04, 2022

Job Description

500! That’s the approximate number of clinical documents reviewed each year by the Novartis Integrated Scientific Review Committee in Global Drug Development (GDD) and Pharma Global Medical Affairs (Pharma GMA).

The Integrated Scientific Review Committee Lead (ISRC Lead) plays a key role in the review and approval of clinical documents for multiple therapeutic areas primarily across Global Drug Development (GDD) and Pharma Global Medical Affairs (GMA).

The ISRC Lead follows documents from ISRC submission to finalization, including meeting preparation, meeting management and documentation via minutes for completeness, consistency and process adherence. In collaboration with the ISRC Co-Chairs (Therapeutic Area CD Head, and GMA Head) you will act as project manager in the review cycle and associated activities for high-quality and efficient ISRC meeting. The key outcomes are high-quality concept sheets, protocols and clinical development plans using systems including Collaborative Authoring Tool (CAT). You will participate in process/guidance review, best practice identification, trainings, ISRC process overview presentations, testing of new collaboration tools and other team projects.

This position is part of the larger Clinical Processes & Solutions team within Clinical Development Excellence (CDE).

Your key responsibilities:
Your responsibilities include, but are not limited to:
• Lead ISRC Review process for approximately 100+ clinical documents each year
• Ensure appropriate ISRC documentation and meeting management across 2 or more therapeutic areas
• Assist in the development of high-quality protocols and other clinical documents via the ISRC processes/workflow related questions, and training and guidance.
• Works with various systems and trackers to ensure smooth ISRC workflow including CAT, Please Review, Document Management System, etc. and you may work on system improvement as appropriate
• Serves as back-up to fellow ISRC Leads and may attend ISRC Meetings to take minutes or co-facilitate the sessions
• Leads timely key data entry to create reports from appropriate systems and facilitate tracking of key metrics for the ISRC Office
• Assist in audits and inspection readiness related to ISRC process/documentation
• Supports other ISRC and Clinical Development Excellence projects and activities such as updating guidance, contributing to trainings and best practice sharing.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:
• Bachelors degree in Science; Advanced degree, or equivalent, in science or healthcare is 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 skills
• Ability to influence wide variety of collaborators in a matrix environment

Why Novartis?
766 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!
Global Drug Development
Clinical Development Excellence GDD
Research & Development
Full Time
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Integrated Scientific Review Committee Lead

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