Medical Writer

Analyze and interpret all types of medical results including vital signs, clinical laboratory values, adverse events, electrocardiograms (ECGs), diagnostic procedures, and various pharmacodynamic (PD) endpoints. Compile and write Phase I and Phase II clinical trial documents including clinical study reports (CSRs), stand-alone safety narratives, and synoptic CSRs. Review and evaluate study results to determine whether or not the safety objectives and/or endpoints were met, accurately reflecting the results in the safety text. Perform peer QC function of safety text prior to inclusion in the CSR. Review reports for completeness and accuracy assuring that the safety text fits into the CSR as whole and recommending changes or rewriting, as appropriate. As the project Report Lead on a multi-disciplinary scientific team, ensure quality and on-time delivery of scientific reports. Deliverables are compliant with applicable regulatory standards (i.e. Good Clinical Practice, International Conference on Harmonisation guidelines) and client specifications.