Associate Medical Writer, In Vitro Diagnostic Regulation (IVDR) Writing Services

This a Full Remote job, the offer is available from: Indiana (USA) Associate Medical Writer, In Vitro Diagnostic Regulation (IVDR) Writing Services Job Type: Full-Time, Remote Experience Level: Experienced At Criterion Edge, we’re committed to empowering companies to deliver better healthcare solutions. By leveraging best-in-class writing processes, technology, and expertise, we empower healthcare companies to achieve their global regulatory goals with superior quality, speed, and budget control. Be on the leading edge by applying your regulatory writing expertise and leadership skills to the development, management and writing of regulatory-compliant performance evaluation reports (PER) projects with top industry clients. In the role of Associate Medical Writer, you will have the opportunity to work closely with other writers, project managers and project support specialists to support and lead multiple PER writing projects that support EU IVDR submission requirements for the client’s portfolio of IVD products. Please note that previous PER or CER writing experience and management of medical regulatory writers is required for this role. The ideal candidate is looking to build their medical writing career and should possess basic scientific knowledge and well-developed written and oral communication skills. We value proactive thinkers with the ability and desire to work in a multifunctional team setting, producing documents and reports that align with the highest professional standards. Specific responsibilities include: As a support member on our project writing team, you will actively collaborate and work together with other members of the project writing team to produce assigned written documents and reports to a high standard. Your specific responsibilities include:

• Take direction from other members of the project writing team on assigned writing tasks.
• Plan and organize your workload on assigned projects and tasks and adhere to established project timelines and workload estimates.
• Understand client and project expectations and work to meet those expectations through teamwork, adherence to deadlines, problem-solving and scientific knowledge.
• Consistently monitor your work for accuracy and quality by following established internal QC processes.
• Work with Criterion Edge Project Manager to accurately document your assigned project tasks, task timeline estimates and assignments into the project plan. Provide weekly progress updates.
• Demonstrate initiative and sound judgement when faced with less familiar project requirements and/or document situations or challenges. Seek understanding and additional clarity from the Project Lead and/or Project Management before proceeding.
• Establish and maintain effective working relationships with co-workers, managers, and clients.
• Attend internal meetings as needed.
• Required Experience:
• Previous experience writing CERs and/or PERs and related documents in accordance with MEDDEV 2.7/1 rev 4 and/or EU MDR and/or EU IVDR
• Effective written, verbal and presentation skills in technical/laboratory diagnostics
• Strong command of medical and laboratory terminology
• Demonstrated ability to identify and adapt to shifting priorities and competing demands
• Skilled in document development and management using Word, Excel, PowerPoint and EndNote
• Training and degree in science, engineering, or medical field(s). Scientific/research background required, with a deep understanding of research design, methodology, and statistics

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