Medical Writer I - (Princeton, NJ)

Key responsibilities Performs study start up responsibilities by: * Creating, modifying and finalizing Site Manuals, associated fillable forms, Quick Reference Guides and labels * Creating, modifying and finalizing Image Quality Assessment/Photograph Quality Assessment (IQA/PQA) Summaries * Creating, modifying and finalizing Quality Control (QC) Summaries * Creating, modifying and finalizing Study Start-Up related Compliance Reports (CRs) such as Notes to File (NTFs), Corrections and Deviation Reports * Creating, modifying, and finalizing Key Points Documents (KPDs) from CRs * Creating, modifying and finalizing paper Source Documents based on ToOs * Creating, reviewing, modifying and finalizing MedComm Meeting Minutes * Attending internal and external meetings relating to the Site Manuals, IQA/PQA/QC Summaries, CRs/KPDs