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Scientific Review Committee Leader
1 week ago
About the Role
The Central Integrated Scientific Review Committee Lead plays a crucial part in ensuring high-quality clinical documents are reviewed and approved across various therapeutic areas. As a Scientific Review Committee Leader, you will be responsible for managing the C-ISRC review process, which involves following documents from submission to finalization. This includes meeting preparation, management, and documentation via minutes for completeness and consistency.
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. The key outcomes of this role are high-quality concept sheets, protocols, and clinical development plans. Key systems used include 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:
- Manage the C-ISRC review process for approximately 100+ clinical documents each year.
- Ensure appropriate C-ISRC documentation and meeting management.
- Assist in the development of high-quality protocols and other clinical documents via addressing C-ISRC processes/workflow related questions, and training and guidance as appropriate.
- Work 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.
- Serve as back-up to fellow C-ISRC Leads and may attend C-ISRC meetings to take minutes or co-facilitate the sessions.
- Manage timely key data entry to create reports from appropriate systems and facilitate tracking of key metrics for the C-ISRC Office.
- Assist in audits and inspection readiness as needed/related to C-ISRC process/documentation.
- Support other C-ISRC and Clinical Development projects and activities as appropriate (e.g., updating guidance, contributing to trainings and best practice sharing, etc.).
Minimum Qualifications:
- A minimum Bachelor's degree in science; an Advanced degree, or equivalent, in science or healthcare is preferred.
- 5+ years' 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.
About Us:
Novartis Farmacéutica is a community of smart, passionate people who collaborate, support, and inspire each other to achieve breakthroughs that change patients' lives. We combine innovative science with a commitment to helping people with disease and their families.
We Offer:
You'll have the opportunity to work with a talented team, develop your skills, and contribute to our mission of improving patients' lives. If you're passionate about scientific review, governance, and regulatory affairs, we encourage you to apply.
