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- Tasks: Lead the review of clinical documents and manage C-ISRC meetings for high-quality outcomes.
- Company: Join Novartis, a leader in transforming healthcare through innovative science and collaboration.
- Benefits: Enjoy hybrid working, professional growth opportunities, and a supportive community.
- Why this job: Make a real impact on patients' lives while working in a dynamic and inclusive environment.
- Qualifications: Bachelor’s degree in science; 5+ years in the pharmaceutical industry required.
- Other info: Be part of a diverse team committed to excellence and innovation.
The predicted salary is between 36000 - 60000 ÂŁ per year.
Central Integrated Scientific Review Committee Lead
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Central Integrated Scientific Review Committee Lead
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Join to apply for the Central Integrated Scientific Review Committee Lead role at Novartis
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Summary
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.
Summary
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 meeting. 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 in a hybrid working approach.
About The Role
Your responsibilities will include;
- Manages C-ISRC Review process for approximately 100+ clinical documents each year
- Ensures appropriate C-ISRC documentation and meeting management
- Assists 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
- Works 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
- Serves as back-up to fellow C-ISRC Leads and may attend C-ISRC meetings to take minutes or co-facilitate the sessions
- Manages timely key data entry to create reports from appropriate systems and facilitate tracking of key metrics for the C-ISRC Office
- May assist in audits and inspection readiness as needed/related to C-ISRC process/documentation
- Supports 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 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 wide variety of stakeholders in a matrix environment.
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?
https://www.novartis.com/about/strategy/people-and-culture
Commitment To Diversity & Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
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: https://talentnetwork.novartis.com/network
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? https://www.novartis.com/about/strategy/people-and-culture
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: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Seniority level
-
Seniority level
Mid-Senior level
Employment type
-
Employment type
Full-time
Job function
-
Job function
Research, Analyst, and Information Technology
-
Industries
Pharmaceutical Manufacturing
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Contact Detail:
Novartis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Central Integrated Scientific Review Committee Lead
✨Tip Number 1
Familiarise yourself with the Central Integrated Scientific Review Committee (C-ISRC) processes and workflows. Understanding how the committee operates will help you demonstrate your knowledge during interviews and show that you're ready to hit the ground running.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those who have experience with clinical document reviews. Engaging with them can provide valuable insights and potentially lead to referrals, increasing your chances of landing the job.
✨Tip Number 3
Brush up on your project management skills, as this role requires managing multiple clinical documents and meetings. Consider obtaining a certification or attending workshops that focus on project management within the healthcare sector.
✨Tip Number 4
Prepare to discuss your experience with IT systems and trackers relevant to clinical development. Being able to articulate your familiarity with tools like Document Management Systems and Collaborative Authoring Tools will set you apart from other candidates.
We think you need these skills to ace Central Integrated Scientific Review Committee Lead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in clinical document management and project management. Emphasise your knowledge of the clinical drug development process and any specific systems you've worked with, such as Document Management Systems.
Craft a Compelling Cover Letter: In your cover letter, express your passion for transforming healthcare and how your skills align with the responsibilities of the Central Integrated Scientific Review Committee Lead. Mention your ability to influence stakeholders and your experience in managing clinical documents.
Showcase Your Communication Skills: Since excellent communication is key for this role, provide examples in your application that demonstrate your interpersonal and presentation skills. Highlight any experience you have in meeting management or training others.
Highlight Relevant Qualifications: Ensure you mention your educational background, especially if you have an advanced degree in science or healthcare. Also, include any certifications or training related to Good Clinical Practice (GCP) or regulatory processes.
How to prepare for a job interview at Novartis
✨Understand the Role Thoroughly
Before your interview, make sure you have a solid grasp of the responsibilities and expectations of the Central Integrated Scientific Review Committee Lead. Familiarise yourself with clinical document review processes and the specific systems mentioned in the job description, such as the Collaborative Authoring Tool (CAT).
✨Showcase Your Experience
Highlight your 5+ years of experience in the pharmaceutical industry during the interview. Be prepared to discuss specific projects where you've managed clinical documents or led meetings, demonstrating your understanding of trial design, GCP, and regulatory processes.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills and ability to manage multiple stakeholders. Prepare examples from your past experiences where you successfully navigated complex situations or improved workflows, particularly in a matrix environment.
✨Demonstrate Communication Skills
As this role requires excellent interpersonal and communication skills, practice articulating your thoughts clearly and confidently. You might be asked to present a brief overview of a clinical document or explain how you would facilitate a C-ISRC meeting, so be ready to showcase your presentation abilities.
