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