• Authoring and Quality Assurance of Project Activities • Executes project specific activities with high quality and in defined timelines according to standard processes and operating procedures • Marking /QC/Review and/or editing of pertinent documents such as Clinical study documents for regulatory submission • Protocol and results summaries to support clinical trial disclosure commitments • Systematically perform quality control checks of documents prepared by colleagues against checklist • Perform detailed analyses on a planned and ad hoc basis, relating to processes and their outputs • Completion of Internal and Client specific training • Assist in mentoring and training of team members