- This candidate needs to have strong Medical Device exp (no Pharma/Bio) and has a good medical writing/technical writing background.
- They will be evaluating documentation and needs to be strong with performance evaluations, document creation and have a demonstrated PM background to manage this process.
- Key skill sets are: Medical Device, Writing and PM background, EU experience
- It's important that the resource has familiarity with the analytical and chemical aspects of diagnostic devices as they relate to product development and R&D. They would really also like this person to have SharePoint skills as the current system they are using is not useful and would like to bolster.
- Technical Writing skills
- Literature review of scientific validity reports which is reviewing associated device with chemical conditions and then performing the actual writing assessment of it
- Reviewing and executing IVDR technical files (clinical performance, scientific literature, protocol reports, labeling reports)
- Project coordinating aspects of the IVDR program based on scientific literature review and resulting writing assessments
- SharePoint skills
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IVD / IVDR Project Manager - Chicago, United States - Planet Pharma
Description
Project Manager - IVDR - Performance Evaluation Coordinator
*****Please no 3rd party vendors*****
*****No out of state candidates.*****
*****Do not apply unless you are qualified for the position*****
Location: Onsite in Chicago, IL - if you are not able / willing to work onsite - please do not apply.
Target Pay Rate: $60 - $70/hour
Project Manager - IVDR - Performance Evaluation Coordinator
Our client in Illinois, a diagnostics company, is looking for a Performance Evaluation Coordinator (PEC) to assist in their IVDR efforts. They want the resource to be strong on the program management/coordination side, but not so fully strategic that they can't execute which is extremely important to them.
Aspects of this role include: