Contract \ Contract-to-Hire Technical Writer
Job Description
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.
• Experience with EndNote, SharePoint and SAP
• Knowledge or experience in respiratory care and/or sleep medicine a plus