We are currently recruiting for Performance Evaluation Report Writer’s from the Medical Device/In vitro Diagnostic (IVD) industry to join an already established team within Maetrics. This will be a home based role with both permanent and contract opportunities available.
To join Maetrics PER team in the review and authoring of performance evaluation reports (PER) for the client
Will be responsible for writing, reviewing and updating the PERs for all client IVD product families
Attend PER initial meetings to gain an understanding of the product from IVD product and technical leads
Liaise with product and technical leads to gather information and data required to complete/update performance evaluation plan (PEP) and PER
Liaise with PMS/vigilance leads to gather information and data required for PERs, as appropriate to the class and nature of the IVDs
Submit new, updated and reviewed PERs for internal QC
Attend client review board meetings to answer questions on submitted PERs
Follow Maetrics and Client PEP and PER (‘PEPPER’) procedures and protocols
Manage follow up questions/actions from the notified body reviewing the PEPPER.
Science degree (at least at Masters level) in something like molecular biology, or generics
At least 2 years of medical writing experience in the IVD industries
IVD industry experience would be strongly desirable – especially R&D
A strong biochemical / molecular biology / chemistry analytical background in a diagnostic related discipline.
Previous experience in assay development
Excellent English technical writing and grammar skills; Ability to accurately interpret data and present complex information in a clear and concise written manner
Ability to interpret, analyse, and report statistical data from analytical and/or clinical performance studies (as appropriate to the IVD)
Expertise in searching medical literature and databases for clinical and technical information