Technical Writing Consultant II

Technical Writing Consultant II
5 months
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 Philips 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. 

Thanks and Regards,
Ali Khan
APN Software Services, Inc.
39899 Balentine Drive, Suite 385, Newark, CA 94560           
Direct: 510.870.8798 | Fax: 510.623.5055 | ali@apninc.com 

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