Job Overview The Medical Writer plays a crucial role in preparing clinical reports and literature reviews for the medical device industry. Responsibilities include conducting systematic searches of peer-reviewed publications, national registries, risk management files, and quality data to compile relevant information. Report preparation involves summarizing data found and drafting analyses for review by senior writers or designees. Key Responsibilities - Identify pertinent internal and external sources of clinical data and conduct thorough literature searches of peer-reviewed publications. - Prepare clinical documents according to applicable regulations and industry procedures using relevant information compiled from research, publications, risk management files, and post-market data. - Summarize findings and draft analyses and conclusions based on clinical and post-market data for review by managers or designees. - Distribute final draft reports to regulatory groups to verify and approve content. - Prepare reviews of peer-reviewed literature for inclusion in surveillance reports. - Support audit activities, including participation as a subject matter expert as needed. - File work in archives, provide documentation as a service, and provide progress reports. Requirements - Proficient in English – written and spoken. - Excellent communication skills. - Demonstrated technical and writing competence. - Understanding of statistical methods. - Ability to analyze and interpret scientific data. - Ability to work within tight deadlines and adjust priorities. - Takes actions that are best for the company versus individual goals. - Encourages collaboration across teams and departments. - Demonstrates sound business ethics and consistency. - Strong ability to interpret and disseminate clinical studies/medical product information. - Basic understanding of regulatory compliance for medical devices. Education and Experience - Candidates must have a degree in health, life sciences, engineering, or a related field. - MD, MS, and PhD preferred. - Demonstrated authorship of scientific publications will be an asset. - Minimum 2-5 years of experience in medical writing, clinical affairs, regulatory affairs, or product engineering is required, with a preference for those with similar work experience in the orthopedic industry. - In lieu of industry experience, 3-5 years as a professor or senior investigator in a healthcare-related field with a demonstrated record of research and publications is acceptable.