Medical Writer

Support regulatory submissions and other associated activities by authoring CEP’s and CER’s in compliance with MDD 93/42/EEC as amended by 2007/47/EC, MED DEV 2.7/1, rev 4, MDR 2017/745, MDCG 2020-1, MDCG 2020-5, MDCG 2020-6 and providing input from the CER into other reports (e.g. clinical evaluation plans and reports, Postmarket Clinical Follow-up Plans and Reports (MEDDEV 1.12/2, rev 2, MDCG 2020-7, MDCG 2020-8) period safety update reports, post-market surveillance reports, Summary of Safety and Clinical Performance (MDCG 2019-9), etc.), including performing literature searches. Manage activities with the accountability for successful completion of all deliverables. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional teams to understand upcoming medical writing needs and manage resourcing and assignments to ensure timelines are met.

According to JobzMall, the average salary range for a Medical Writer in 12050 Lone Peak Pkwy, Draper, UT 84020, USA is $71,417 to $118,609. This range is based on the salaries of experienced professionals in the field who may have additional certifications or experience.

Edwards Lifesciences (NYSE: EW) is the global leader in the science of heart valves and hemodynamic monitoring.