Clinical Evaluation Report Medical Writer – Contractor

Job Description: • Direct responsibility for writing documents or document sections on assigned projects • Able to organize own project workload and tasks, identify project needs and adhere to project timelines • Understand client expectations and work to meet those expectations through teamwork, adherence to deadlines, problem-solving and scientific knowledge • Effectively collaborate with other members of the project writing team • Working with a Criterion Edge Project Manager, document your assigned tasks, time estimates and due dates into the Asana project plan • Provide weekly progress updates • Ensure all data presented in the document are clear, complete, accurate, and concise • Ensure all statements and conclusions are integrated, balanced, supported by appropriate data, and consistent across all related documents • Receive expert/scientific review comments and adjust the document content as required based on internal and external feedback • Stay abreast of current medical writing best practices and relevant regulatory knowledge • Proactively identify potential project risks and bring those forward to the overall project team to discuss and identify solutions • Participate in quality control (QC) checks for accuracy following established internal QC processes • Provide written and verbal feedback to junior staff and managers when appropriate • When requested, serve as a project mentor to assist in the training and development of junior staff on your project team(s) • Establish and maintain effective, professional working relationships with co-workers, managers, and clients • Demonstrate initiative and sound judgement when faced with less familiar project requirements and/or document situations or challenges. Requirements: • 2+ years of direct writing experience in pharmaceutical, medical device, in vitro device or related academic fields • Minimum of a BSc in a life sciences or related discipline / related field • Advanced word processing skills, including Microsoft Office (including Word), Adobe Acrobat, Excel and collaborative document sharing platforms such as SharePoint; ability to learn and adapt to various IT systems • Familiar with all current and applicable guidelines and regulations governing the assigned project • Knowledge of and experience with systematic literature review (SLR) methodology and best practices, including Level 1 and Level 2 literature screening, data extraction and weighting and appraisal of data sets • High level of English fluency or native English speaker, with excellent oral (including presentation) and written communication, including grammatical/technical writing skills • Able to interact confidently with external stakeholders and communicate with others effectively and clearly • Capable of working independently to achieve assigned project goals with minimal supervision • Reliably produces high-quality written deliverables in accordance with customer and project requirements and agreed timelines • Excellent attention to detail and accuracy • Contributes, collaborates, shares responsibilities, and supports other team members to ensure success with tasks/projects • Demonstrates scientific rigor and understanding of the scientific process in written documents. Benefits: • Flexible work arrangements • Professional development opportunities