Technical Writing Consultant II

Duration: Until end of year with potential to extend
Location: Monroeville PA

Responsible for creating/writing clinical evaluation documents (CEPs, CERs, PMCF plan) to demonstrate the safety and performance of medical products (Class I, IIa and IIb ) which are part of the current or planned Clients  Respironics, Sleep and Respiratory Care (SRC) product portfolio: 

o Create CEPs, CERs and PMCF plans 
o Conducts reproducible, thorough, and objective literature searches. 
o Evaluates the contribution of the available clinical literature to establish performance and safety of therapeutic and diagnostic medical devices (products). 
o Extracts and relevant information clinical data and creates tables for data analysis 
o Reviews product risk information, device labeling, and product claims in light of device safety and performance information. 

Skills 
• Experience planning and executing internet literature searches using databases such as PubMed and EMBASE. 
• Deep knowledge of MEDDEV 2.7.1 Rev. 4 and EU MDR 
• Experience in updating CERs from MEDDEV 2.7.1 Rev. 3 to Meddev 2.7/1 Rev4 
• Understanding of research methodology and regulatory requirements 
• Excellent organizational and communication skills 
• Ability to work with multi-disciplinary teams 
• Ability to manage multiple projects with conflicting deadlines. 
• Ability to critically appraise and review clinical trial data from peer reviewed publications 
internal sources. 
• Ability to translate engineering and marketing data into a device performance context. 
• Knowledge of AMA writing guidelines; 
• Proficiency with computer programs such as MS Word, Excel and PowerPoint. 
• Experience with EndNote, SharePoint and SAP 
• Knowledge or experience in respiratory care and/or sleep medicine a plus 

Want to apply later?

Type your email address below to receive a reminder

Apply to Job

ErrorRequired field
ErrorRequired field
ErrorRequired field
Error
Error
insert_drive_file
insert_drive_file