When 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 (CISR Committee 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.
This role can be based in London, UK or Dublin, Ireland in a hybrid working approach.
About the RoleYour responsibilities will include: Manage 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: Minimum Bachelor's degree in science; Advanced degree, or equivalent, in science or healthcare 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.You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
Learn more.
Why Novartis: Helping people with disease and their families takes more than innovative science.
It takes a community of smart, passionate people like you.
Collaborating, supporting, and inspiring each other.
Combining to achieve breakthroughs that change patients' lives.
Ready to create a brighter future together?
Join us.
Join our Novartis Network: Not the right Novartis role for you?
Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: Join here.
GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.
#J-18808-Ljbffr