Central Integrated Scientific Review Committee Lead – Global Pharmaceutical Company
Please ensure you read the below overview and requirements for this employment opportunity completely.
Contract: 12 - 18 months
Location: London (Hybrid)
Salary: £360 per day via Umbrella
SRG are working with a Global Pharmaceutical company to help them find a Central Integrated Scientific Review Committee Lead to join their busy team.
The Central Integrated Scientific Review Committee Lead (C-ISRC 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 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.)
Candidate Requirements:
* Minimum Bachelors 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