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

About the role

The Associate Medical Writer will support and lead multiple PER writing projects that support EU IVDR submission requirements for the client's portfolio of IVD products. This role requires previous PER or CER writing experience and management of medical regulatory writers.

Responsibilities

• 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.

Requirements

• 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