Medical Writer jobs in Irvine, CA

• Researches, compiles, and edits subject matter related to dental industry using PubMed, Google Scholar, and Cochrane databases; determines relevant datasets to extract and incorporate into literature.
• Creates Clinical Evaluation Reports (CER) and other technical documents including but not limited to procedure manuals.
• Sets timelines for completion and updates of CERs.
• Develops documentation for instructional, descriptive, reference and/or informational purposes.
• Conducts interviews and reviews internal documents and business analytics to develop reports and documentations.
• Integrates various sources of information into a uniform style and language.
• Interviews subject matter experts (SMEs) to write, rewrite, or clarify research or review articles.
• Collaborates with the Research and Development (R&D) team to ensure standard operating procedures (SOPs) are adhered to; recommends changes to workflow.
• Creates and updates SOPs as needed.
• Leads post-market surveillance activities to gather data on competitors; analyzes and prepares PMS report on data.
• Responds to auditors' questions.
• Collaborates with the Complaints Department as an advisor for the complaints process.
• Perform other related duties and projects as business needs require at direction of management.

• Bachelor’s degree required. Master’s degree, DDS, PharmD, PhD or equivalent level of education.
• Minimum five (5) years of experience within the medical device industry; experience in dental industry preferred.
• Minimum three (3) years of experience in writing Clinical Evaluation Reports and Post Market Surveillance Reports.
• Knowledge of US and international regulatory requirements pertaining to medical devices preferred.
• Experience in complaint handling and adverse event reporting preferred.

Pay: $78,728-$104,997 annually