FAQs
What is the primary role of the CISR Committee Lead?
The primary role of the CISR Committee Lead is to oversee the review and approval of clinical documents across therapeutic areas in Development, ensuring high-quality and efficient meetings for the Central Integrated Scientific Review Committee (C-ISRC).
Where can this position be located?
This position can be based in London, UK or Dublin, Ireland, employing a hybrid working approach.
What are the key responsibilities of the CISR Committee Lead?
Key responsibilities include managing the C-ISRC review process for approximately 100+ clinical documents each year, ensuring appropriate documentation and meeting management, assisting in the development of high-quality protocols, and managing timely data entry for key metrics.
What qualifications are required for this position?
A minimum of a Bachelor’s degree in science is required, with an advanced degree or equivalent in science or healthcare preferred, along with 5+ years of experience in the pharmaceutical industry.
Is experience in clinical drug development necessary?
Yes, a strong knowledge of the clinical drug development process, including trial design, GCP, and regulatory processes, is necessary for this role.
What skills are needed for the CISR Committee Lead position?
Excellent interpersonal, communication, presentation, and meeting management skills, as well as advanced medical/scientific writing abilities, are essential for this role.
Will the CISR Committee Lead need to support other projects?
Yes, the CISR Committee Lead may support other C-ISRC and Clinical Development projects and activities, such as updating guidance and contributing to trainings.
Are there specific systems or tools the CISR Committee Lead will work with?
Yes, the CISR Committee Lead will work with various systems and trackers, including the Collaborative Authoring Tool (CAT), Document Management System, and others to ensure a smooth C-ISRC workflow.
Does the role require influencing stakeholders?
Yes, the ability to influence a wide variety of stakeholders in a matrix environment is important for this role.
What kind of work environment does Novartis promote?
Novartis is committed to building an outstanding, inclusive work environment with diverse teams representative of the patients and communities served.