Clinical Research Writer (remote)

Requisition ID: 59683 Title: Clinical Research Writer (remote) Division: Arthrex, Inc. (US01) Location: Remote Salary Range: Salary Minimum: $100,000.00 Salary Maximum $172,500.00

 

 

 

 

**This position is based in Naples, FL. Open to remote for the right candidate. If remote, travel to HQ for one week every quarter is required**

 

Arthrex is a global medical device company and leader in research, new product development and medical education in orthopedics. With a corporate mission of Helping Surgeons Treat Their Patients Better™, Arthrex has pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year that support all aspects of orthopedics. The Orthopedic Research department based in Naples; includes a team of clinical, biomaterials and biomechanical professionals. Arthrex is actively searching for a Clinical Research Writer to join the Orthopedic Research department. The successful candidate will work alongside the team organizing and overseeing research studies to contribute to advances in the medical community. Experience as a clinical research professional and knowledge of clinical regulatory regulations is required. Excellent communication and analytical skills, and a bachelor’s degree in a related field are required for success in this position. Clinical Research Professional certification is also strongly encouraged. Come join our growing talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

 

Main Objective:

The position provides overall management of the technical writing from the initial study concept through study completion, final/report, and publication. The position will mainly focus on developing clinical study protocols and associated documents, facilitating protocol amendments, drafting publications, reviewing publications, drafting interim study reports, and completing final study reports. The purpose of this job is to provide technical and medical writing support for clinical study projects.

 

Essential Duties and Responsibilities:

• Perform comprehensive literature searches to develop in-depth knowledge and understanding of current scientific literature required to support clinical study design
• Combine an understanding of scientific and research methodology and medical device regulations and guidelines to support clinical research technical writing needs.
• Extracts statistical data summaries, study conduct information, and study design information to prepare interim and final study reports
• Prepares clinical study documents and coordinates with additional collaborators including product management, statistician, regulatory affairs, clinical research management, and contract research organizations (CROs)
• Manage timelines required by product development …