Central Integrated Scientific Review Committee Lead

Novartis; London; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a Central Integrated Scientific Review Committee Lead in London. This role involves managing the review process for clinical documents and ensuring adherence to standards. Ideal candidates will have a strong background in clinical development and excellent communication skills. The position supports hybrid working arrangements.

Qualifications

• 5+ years' experience in pharmaceutical industry.
• Strong knowledge of clinical drug development process.

Responsibilities

• Manages C-ISRC Review process for 100+ clinical documents each year.
• Ensures appropriate documentation and meeting management.

Skills

Interpersonal Skills

Communication Skills

Presentation Skills

Meeting Management Skills

Scientific Writing

Project Management

Influencing Skills

Education

Bachelor’s degree in science

Advanced degree in science or healthcare

Tools

Document Management System

Collaborative Authoring Tool (CAT)

Job description

Central Integrated Scientific Review Committee Lead

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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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