Criterion Edge

Clinical Operations

• Organizing and facilitating client and team project meetings
• Developing and maintaining new project plans using Asana project management software
• Document control – interfacing with clients and CE writing team to obtain, organize and store required project source documents using SharePoint document storage platform
• Tracking and updating all project performance, timing and project estimates at the task level
• Creating and maintaining comprehensive project documentation in Asana
• Reporting to management on progress for all assigned projects
• Assisting technical writing leads with project scheduling and client deliverables
• Additional client interface
• Account management interfacing – project scope changes, project estimates above vs. budgets
• Budget management – maintaining cost control by continuously tracking project progress against planned budgets
• Performing other standard project management duties

Clinical Project Manager

Medical writer

• 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.

Clinical Evaluation Report Medical Writer – Contractor

Content Writer

• Provide consistent, expert scientific oversight on all assigned projects.
• Collaborate with the Resourcing team to assign appropriate writing resources to each project.
• Oversee initial scoping of new projects and attend project kick-off meetings.
• Review regulatory documents and responses to regulatory authorities, specifically working on Performance Evaluation Reports (PERs).
• Conduct high level review and provide feedback to project team.
• Review/oversee the systematic literature review process (e.g. screen articles against inclusion/exclusion criteria, extract data from included studies, interpret study results, synthesize literature, and prepare summaries into formal reports) for IVDs.
• Provide input into company process development and improvement.
• Ensure documents are produced in accordance with procedures, internal and external guidelines, and electronic templates.
• Coach all project-related activities to ensure alignment with applicable regulatory requirements and Criterion Edge quality standards.

Clinical Project Manager

Clinical Evaluation Report Medical Writer – Contractor

Associate Director, In Vitro Diagnostic Regulation – Writing Services