Your new company
My client is a global biopharmaceutical company with a goal of contributing to healthcare innovation and environmental sustainability. They are focused on improving people's quality of life, specialising in Oncology, neurology, rare diseases, ophthalmology and immunology. There is an opportunity for a Medical Device Clinical safety team member to join their Clinical Safety team.
Outside IR35
Hybrid / Remote UK
Your new role
As a highly motivated individual, your primary responsibility is to support clinical investigations of Medical Devices by developing and providing safety input into core Medical Device clinical investigation documents, including the Clinical Investigation Plan (CIP/Protocol), Investigator's Brochure (IB), and Reference Safety Information (RSI).You will be expected independently and strategically to lead the development of safety deliverables for Medical Device clinical investigations.
What you'll need to succeed
* Medical Devices clinical investigation expertise: significant expertise and hands-on experience in safety activities related to Medical Devices clinical investigations, evidenced by practical experience in roles with safety responsibilities in Medical Device clinical investigations.
* Expert-level understanding and practical ability to apply ISO 14155:2020, and demonstrated a strong ability to apply the standard in practice across all phases of Medical Devices clinical investigations.
* Experience developing and providing safety input for core Medical Devices clinical investigation documents, including the Clinical Investigation Plan (CIP/Protocol), Investigator's Brochure (IB), and Reference Safety Information (RSI), with demonstrated ability independently and strategically to lead the development of these deliverables for Medical Devices clinical investigations.
What you need to do now
Before you apply for this position, it is vital that you are in possession of a UK passport or relevant visa to work without restrictions in the UK and residing in the UK.
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call Roberta Atkins on 03330106292