Literature Searches and Reports Expert
Consultant
Introduction
Since 2021 Joshua Spencer, BSc (Hons) + DIPP, has joined the Qserve Group as a consultant, working for Qserve Group UK Ltd whose responsibilities range from the running of literature searches and reviews, as well as writing various reports and documents for a variety of regulatory activities. As consultant he supports the IVD team in various projects.
Before Qserve
Joshua is a qualified biochemist and microbiologist having graduated from the University of Nottingham Trent with a Bachelors (Honours) and received a diploma in professional practice (DIPP) for his placement year within a small biotech company. Joshua’s experiences at that biotech company provided him with experience in manufacturing according to ISO 13485 and working under IVD regulations. This included taking part with tasks centered around quality control (QC), taking responsibility for the maintenance of various laboratory equipment and its validation and helping ensure compliance under ISO 13485. With the completion of his degree, Joshua has been furthering his scope and understanding of the regulatory world applying his experiences in industry as part of the Qserve team. He will initially focus on the effective execution of literature searches for inclusion into a clients technical file as this is a new skill for the IVD regulatory world and very much in demand.
Joshua's experience with Qserve
The resources and tools that Qserve uses are relatively straightforward and have been very useful in helping me to better understand background concepts surrounding regulatory work. I am pleased with the efforts being made for training that will help provide assistance with clinical evaluations work, particularly in the case of literature search and view.
The latest and most recurring projects are usually literature searches which have so far been performed for many companies with a variety of different devices. Responsibilities on these projects is being broadened with growing experience and so this has led to performing the planning, appraisal and report write ups for literature searches focused on scientific validity (SV) and state of the art (SOTA).
The key expertise areas of Joshua:
• Experience with literature searches for simple and complex devices
• Familiar with scientific concepts and terminology for literature appraisal
• Able to write concise and detailed reports including those related to literature reports
• Experienced in regulatory activities
• Flexible approach to work
• Team player, organized worker, with close attention to detail, supporting the IVD team
• Good analytical, writing and communication skills particularly around clinical evaluation
• Experience using citation managers like EndNote 20