Clinical Evaluation Report Medical Writer – Contractor

🌍 Remote, USA 💹 Full-time 🕐 Posted Recently

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.

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.