Life Sciences & Technology
| Clinical Research & Clinical Affairs
A BDN client based in New Jersey is looking for a mid-level medical writer who can provide one year of remote contract coverage. Our client is looking for a strong mid-level medical writer who can complete CERs, taking them from drafts through to completion including final analysis. Our client has multiple different products that were previously classified as class II devices that are now considered class III and will require annual updates going forward. They're looking for candidates who can "own" the process and who can effectively track down the information that will be required to perform this role. Our client has an EU MDR readiness plan with updated SOPs and templates and have created some of the new processes that will be required based on the new regulations, but need resources to help write the CERS, ensure compliance, and work with a cross-functional team to develop the processes and updated documentation that will be needed to reach compliance.
Candidates for this position should have at least 4 - 5 years of relevant experience with at least a year of experience writing CERS according to the requirements associated with MEDDEV 2.7.1 Version 3 or Verison 4. Candidates who hold a doctoral degree will receive additional consideration for this position.