ADVANCED REGULATORY jobs in CAMBRIDGE, United Kingdom #2

for signal detection and evaluation activities for assigned products. Drives production of regulatory periodic reports... and associated documentation and RMPs globally according to the agreed process and timelines; advises on content of regulatory period...

most advanced pieces of technology that will help drive forward a number of different sectors. This means you will never get bored..., Scientific Engineering, Scientific Software, Robotics, Science, Electronics Design, New Product Design, Human Factors, Regulatory...

are responsible for the invention and development of some of the most advanced medical devices in the sector. You will work on site in.... Science, Electronics Design, New Product Design, Human Factors, Regulatory Affairs, Quality Assurance and Field Service...

analysis and reporting process in such a way the evaluation of data will withstand interrogation and examination by regulatory... required. Advanced degree in life sciences and/or Information Technology applied to life sciences is preferred. Experience: 5+ years...

with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the most rigorous standards of quality, timely... the CPM in site selection, verify timely collection of essential study documents, such as regulatory and ethics committee...

with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the most rigorous standards of quality, timely... the CPM in site selection, verify timely collection of essential study documents, such as regulatory and ethics committee...

quality) or in response to Regulatory Authority requests. Lead the collection of material for periodic reports e.g. DSUR... close collaboration with the safety vendor to ensure appropriate case processing. Contribute to regulatory authority submissions...

scientific publications, book chapters, grant applications and regulatory documents Being self-motivated... reviews or meta-analyses Advanced skills in Excel and knowledge of VBA Familiarity with the R programming language...

applications and regulatory documents Being self-motivated and enthusiastic, with a genuine interest in healthcare... requirements for this role are: Experience with health economic theory, literature reviews or meta-analyses Advanced skills in...

. Job Description POSITION OVERVIEW: Develops or oversees and ensures that strategic scientific and regulatory input relative to safety... is incorporated into signal management/signal detection processes as well as platforms/systems or oversees other advanced patient...

into study-related activities and documentation, regulatory submissions, responses to regulatory agency inquiries...), and regulatory documents Communicates to senior management key pharmacovigilance findings Represents the Patient Safety...

responsibilities for bi-weekly cross-functional brand team meetings Work with advanced analytics to ensure appropriate understanding... of strict compliance to all appropriate regulatory guidelines to successfully design and execute tactics, programs and tools...

materials - Advanced Analytics to ensure appropriate understanding of impact Knowledge, abilities & experience Education... of strict compliance to all appropriate regulatory guidelines to successfully designand execute tactics, programs and tools...