Medical Writer (100% Remote, Part-Time)

About the role

Our Customer is a corporation that develops, manufactures, and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery. Founded in 1995, their goal was to create innovative, robotic-assisted systems that help empower doctors and hospitals to make surgery less invasive than an open approach. Working with the top medical professionals, they continue to develop new, minimally invasive surgical platforms and future diagnostic tools to help solve complex healthcare challenges around the world. We are seeking a Medical Writer on a contract basis to support our Customer's business needs. Please note that our customer is currently not considering applicants from the following locations: Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, and Tennessee.

Responsibilities

• Authoring sections of Clinical documentation as part of the Clinical Evaluation Reports [CER].
• Acquire knowledge of therapeutic areas, literature review processes and the ability to keep abreast of current literature.
• Participates in and/or performs comprehensive literature searches to develop in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies.
• Work with the clinical librarian to help with conducting literature searches on products/product families.
• Review the scientific literature and critically appraise and write clinical summaries for products and surgical procedures.
• Support the internal team members by adhering to CER timelines and providing data in a timely manner to support global Regulatory activities.
• Interacting with internal teams to understand the plan and strategy for development of the Clinical evaluation reports for new and existing products.
• Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities.
• May assist with creation of clinical content including the preparation of manuscripts, scientific abstracts, conference presentations and posters based on Intuitive clinical trials.
• May author Protocols and/or routine Clinical Study Progress Reports.