Medical Writer Ii-cds

Prepares protocols and CSRs, including interpretation of clinical data and statistical results as appropriate - Work under guidance from colleagues to assist development of protocols, CSRs and other clinical documents on complex studies and programs - Prepare and review patient safety narratives - Leads project management and coordination of narrative projects - Oversee and coordinate other writers on CSR appendices compilation - Prepare documents in accordance with Covance/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines - Participate in review of Statistical Analysis Plan (SAP) and Tables, Figures and Listings (TFLs) to ensure appropriate data presentation for CSR purposes. Provide feedback on SAP and TFLs to project team as needed. - Incorporates internal and/or external review comments on clinical documentation - Prioritize and forward plan workload to a high standard; to advise Management of problems..