Medical Writer II

Responsibilities Defines scope of quality control activities with the document author and the required source documents and data required. Conducts independent quality control review of documents per applicable checklist by checking against source documents to ensure results are accurate. Ensures quality control documentation is complete and accurate and uploaded to the master file per the established business processes. Maintain strong knowledge of clinical regulatory documents requiring quality control review and business processes. Interacts daily with medical writers and/or medical writing managers and interfaces/communicates with applicable cross-functional areas. Communicates and provides deliverables to medical writers, medical writing managers, and others as applicable. Requirements Bachelor's degree required. Bachelor's degree in science, English, or Communication preferred. - years in relevant industry experience in quality control/review of clinical regulatory documents or related experience in an area such as quality assurance, clinical research, drug development, medical writing, regulatory, or product support/R&D. Note: Higher education may compensate for years of experience. Years of experience may also compensate for lower education. Excellent knowledge of organization and content of clinical documents and eCTD structure. Knowledge of drug development and experience with Common Technical Document (CTD) content templates. Excellent oral/written communication, interpersonal/organizational, analytical/critical thinking, and conflict management skills. Superior attention to detail and ability to prioritize multiple tasks/projects. Experience in working with collaborative cross functional teams. Operates with limited oversight. Prepares technical documents to support both domestic and international regulatory submissions. Incorporates text, graphs, charts, tables and statistical analysis. Proofreads, circulates, edits, assembles, inspects and duplicates product submissions. Experience Level = - Years. #J-18808-Ljbffr