CISR Committee Lead (Project Manager)

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CISR Committee Lead (Project Manager)

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Novartis .The Central Integrated Scientific Review Committee Lead (CISR Committee Lead) plays a key role in the review and approval of clinical documents across therapeutic areas in Development. This is a Project Manager level role. The CISR Lead follows 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 include high-quality concept sheets, protocols and clinical development plans. Key systems include the Collaborative Authoring Tool (CAT) and various tracking systems. This role can be based in London, UK or Dublin, Ireland in a hybrid working approach.Your responsibilities

Manages C-ISRC Review process for approximately 100+ clinical documents each yearEnsures appropriate C-ISRC documentation and meeting managementAssists in the development of high-quality protocols and other clinical documents via addressing C-ISRC processes/workflow related questions, and training and guidance as appropriateWorks with various systems and trackers to ensure smooth C-ISRC workflow (including CAT, Please Review, Document Management System, etc.); may work on system improvement as appropriateServes as back-up to fellow C-ISRC Leads and may attend C-ISRC meetings to take minutes or co-facilitate the sessionsManages timely key data entry to create reports from appropriate systems and facilitate tracking of key metrics for the C-ISRC OfficeMay assist in audits and inspection readiness as needed/related to C-ISRC process/documentationSupports 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 industryStrong knowledge of clinical drug development process, including trial design, GCP, regulatory processes, and clinical project managementWorking knowledge of IT systems and trackers, including Document Management SystemExcellent interpersonal, communication, presentation and meeting management skillsAdvanced medical/scientific writing and communication skillsAbility to influence wide variety of stakeholders in a matrix environment.You’ll receive

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