Medical Reviewer

Responsibilities

• Provide medical review of clinical and certain regulatory documents (including Clinical Evaluation Plans and Clinical Evaluation Reports);
• Assess clinical safety and performance data to ensure anatomic, physiologic and clinical accuracy and use the available data to assess the benefits and risks of device use;
• Understand and provide guidance on comprehensive, systematic searches of published medical literature;
• Participate in the planning, development, and delivery of high-quality documents with a proactive approach to project management, including supervision of project timelines and communication of the process and timelines to stakeholders;
• Participate in stakeholder meetings with cross-functional teams;
• Resolve document content issues and questions that arise from the writing / review process;
• Provide status updates on deliverables to management;
• Understand medical writing and regulatory standards and practices;
• Proactively contribute to process improvements and knowledge sharing initiatives;
• Ensure consistency across and within documents; and
• Other duties as assigned (including the possibility of medical writing tasks).

Qualifications

Compensation Information :

145000.00 / Annually - $170000.00 / Annually