Senior Associate, Medical Writing (MD)
Core
Producing Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP), State of the Art (SOA), Post-Market Surveillance (PMS) reports, and FDA reports including HDE, IDE, and HEMA research.
Role type
Associate medical writer (device regulatory)
Builds
Clinical Evaluation Reports, Safety and Clinical Performance summaries, FDA regulatory submissions
Domain
Medical device regulation and clinical evaluation
Required skills
Systematic literature review, Regulatory report writing, Data analysis, Time management, Microsoft Office proficiency, English language proficiency
Responsibilities
Conducting systematic literature reviews for regulatory reports, Reviewing peer work, Escalating project risks, Ensuring deliverable quality and compliance, Managing timesheets and training compliance
Seniority
Associate, individual contributor