[Hiring] Clinical Evaluation Report Medical Writer @Criterion Edge

Role Description

In the role of Medical Writer, you will have the opportunity to work closely with other writers, project managers and support specialists to produce a wide variety of regulatory and scientific reports, plans, and other written deliverables for medical device, pharma/biotech, and in vitro device clients.

• 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.
• Seeks understanding and additional clarity from Project Lead and/or Project Management before proceeding.

Qualifications

• 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.

Company Description

At Criterion Edge, we’re committed to empowering companies to deliver better healthcare solutions. By leveraging best-in-class writing processes, technology, and experience, our expert team of writers and project managers support healthcare companies to achieve their global regulatory goals with superior quality, speed, and budget control.

Be on the leading edge by applying your regulatory and/or scientific writing expertise and leadership skills to the development, management and writing of regulatory-compliant projects with top industry clients.