Job Title: Central Integrated Scientific Review Committee Lead
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* Key Responsibilities:
* Manage the C-ISRC review process for approximately 100+ clinical documents each year.
* Ensure appropriate C-ISRC documentation and meeting management.
* Assist in developing high-quality protocols and other clinical documents by addressing C-ISRC processes/workflow-related questions, training, and guidance as required.
* Work with various systems and trackers to ensure a smooth C-ISRC workflow (includes CAT, Document Management System, etc.). May improve systems as necessary.
* Serve as backup to fellow C-ISRC Leads and attend meetings to take minutes or co-facilitate sessions.
* Manage timely data entry to create reports from relevant systems and facilitate tracking of key metrics for the C-ISRC Office.
* May assist in audits and inspection readiness related to C-ISRC processes/documentation.
* Support other C-ISRC and Clinical Development projects and activities as needed (e.g., updating guidance, contributing to trainings, best practice sharing, etc.).
Requirements:
* Education:
* Minimum Bachelor's degree in science; advanced degree or equivalent in science or healthcare preferred.
* Experience:
* 5+ years' experience in the pharmaceutical industry.
* Skills:
* Strong knowledge of clinical drug development processes, 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.
Benefits and Diversity:
* Diversity and Inclusion:
* Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Clinical Research Experience:
* Desired Skills:
* Budget Management.
* Clinical Research.
* Clinical Trial Protocol.
* Clinical Trials.
* Coaching.
* Data Analysis.
* Data Integrity.
* Lifesciences.
* Risk Monitoring.
* Trends Analysis.