Central Integrated Scientific Review Committee LeadJob ID: REQ-10021368
Date: Oct 14, 2024
Location: Ireland
SummaryWhen 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.
The Central Integrated Scientific Review Committee Lead (C-ISRC Lead) plays a key role in the review and approval of clinical documents across therapeutic areas in Development. Key to the role is following documents from C-ISRC submission to finalization, including meeting preparation, meeting management, and documentation via minutes for completeness, consistency, and process adherence.
In collaboration with the C-ISRC Chair and Co-Chair (Clinical Development Head), you will act as project manager in the review cycle and associated activities for high-quality and efficient C-ISRC meetings. Key outcomes are high-quality concept sheets, protocols, and clinical development plans. Key systems include Collaborative Authoring Tool (CAT) and various tracking systems. Periodic participation in process/guidance review, best practice identification, trainings, C-ISRC process overview presentations, testing of new collaboration tools, and other team projects is encouraged.
This role can be based in London, UK or Dublin, Ireland.
About the RoleYour responsibilities will include: Managing the C-ISRC Review process for approximately 100+ clinical documents each year.Ensuring appropriate C-ISRC documentation and meeting management.Assisting in the development of high-quality protocols and other clinical documents via addressing C-ISRC processes/workflow related questions, and providing training and guidance as appropriate.Working 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.Serving as back-up to fellow C-ISRC Leads and may attend C-ISRC meetings to take minutes or co-facilitate the sessions.Managing timely key data entry to create reports from appropriate systems and facilitate tracking of key metrics for the C-ISRC Office.Assisting in audits and inspection readiness as needed/related to C-ISRC process/documentation.Supporting other C-ISRC and Clinical Development projects and activities as appropriate (e.g., updating guidance, contributing to trainings and best practice sharing, etc.).Minimum QualificationsMinimum Bachelor's degree in science; Advanced degree, or equivalent, in science or healthcare preferred.5+ years of experience in the 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 a wide variety of stakeholders in a matrix environment.Why Novartis?Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!
You'll receive: You can find everything you need to know about our benefits and rewards in the 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.
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Company / Legal Entity: GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.
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