Associate, Medical Writing (MD)
Core
Create and update Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance Reports (SSCP), State of the Art Reviews (SOA), and Systematic Literature Reviews (LRR) for assigned therapeutic areas.
Role type
Associate medical writer (medical device regulatory)
Builds
Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP), State of the Art (SOA), Post-Market Surveillance (PMS) reports, Premarket Approval (PMA) FDA Reports, and Health Economics and Market Access (HEMA) research.
Domain
Medical device regulatory affairs and clinical evaluation
Required skills
Systematic literature review, regulatory reporting, data analysis, time management, error-free writing, compliance adherence
Preferred skills
Proficiency in Microsoft Office Suites (Word, Excel, PPT, SharePoint), oral and written English proficiency
Technologies
Microsoft Word, Excel, PowerPoint, SharePoint
Responsibilities
Perform systematic literature reviews for regulatory reports, alert and escalate project risks, ensure error-free quality of deliverables, ensure training and timesheet compliance, report security incidents and PIMS breaches, comply with QMS, ISMS, and PIMS requirements.
Seniority
Junior, individual contributor