Medical Writing Qc/Regulatory Submission Specialist
Responsibilities included: being a member of the QC team which performed the quality control (QC) of medical writing deliverables. Bookmarked, prepared and linked PDF documents. Performed prepublishing of CRFs, CSRs, IBs, CSPs and other submission documents. Responsible for IND Maintenance for standalone paper and electronic submissions. Supported Senior staff in managing client requests. Identified project needs, tracked timelines and implemented client requests with senior review. Kept abreast of current data, trends, regulatory knowledge and developments in area of expertise. Made decisions or provided alternatives for completing assigned tasks