Medical Writer IV

12-month Contract Onsite in Maple Grove, MN, Plano, TX or Santa Clara, CA Must be able to work on a W2 Position Summary

The Medical Writer provides technical and strategic writing expertise throughout the product development and life cycle process. Daily activities are related to authoring Clinical Evaluation Reporting documents.

The Medical Writer provides technical and strategic writing expertise throughout the product development and life cycle process. Daily activities are related to authoring Clinical Evaluation Reporting documents.

• Write and contribute to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, SSCPs, Regulatory Responses, and other related documentation.
• Evaluate and summarize clinical evidence including data from clinical investigations, literature, post-market surveillance, risk, and post-market clinical evaluations.
• Analyze clinical evidence and results in preparation for product applications and submissions.
• Collaborate with team members and stakeholders in planning for and supporting Clinical Evaluation Reporting-related projects and processes.
• Support additional clinical, regulatory, quality, and engineering-related deliverables as assigned.
• Communicate and collaborate with Sales and Marketing, R&D, Regulatory Affairs, Library Services, Product Performance, Quality Engineering, Clinical Affairs, Clinical Science, Risk Management, and Medical Affairs in completing clinical evaluation project-related deliverables.
• Maintain thorough knowledge of assigned products.
• Identify appropriate sources of relevant data and interpret, evaluate, and incorporate information from various sources including literature, clinical data, and medical references.
• Review IFUs, patient guides, Risk Management files, Clinical Evaluation Protocols, Clinical Evaluation Reports and Plans (CER/CEP), PMS Plans, PMCF Plans/Reports, SSCPs, and physician training materials, ensuring alignment of risk information.
• Participate in responses to complex queries such as those issued by notified bodies and stakeholders.
• Author and contribute to necessary documents for regulatory submissions and communications, risk reviews, and other processes such as regulatory inquiries.
• Ensure quality in all deliverables and documentation with attention to detail, consistency, and integrity of data.
• Ensure compliance with applicable corporate and divisional policies and procedures.
• Ensure compliance with applicable regulations and guidance, including ISO 13485, ISO 14155, ISO 14971, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents.

• Bachelor’s degree or an equivalent combination of education and work experience.
• 6–8 years of medical writing experience in the medical or pharmaceutical industry, or 8+ years of general technical writing experience.
• Experience may include writing experience in a medical, pharmaceutical, medical device, clinical research, medical, or research industry, or a combination of these skills.
• Excellent written and verbal communication skills.
• Experience working with collaborative, cross-functional teams.
• Excellent analytical skills.
• Ability to manage complex tasks and manage time effectively.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.

• Biomedical, sciences, medicine, or similar health-related discipline preferred.
• Clinical Evaluation Report (CER) writing experience preferred.