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Lead Analyst, R&D Technical Writing
- Job ID
- Position Type
- Contract (Full-Time)
- # of Openings
- Preferred 3 years’ experience performing Clinical Evaluations and writing/updating Clinical Evaluation Reports (CERs).
- Knowledge of MEDDEV 2.7.1 Rev. 4 and the European Medical Device Regulation (EU MDR) as it pertains to CERs.
- The candidate should have excellent written and verbal communication skills, possess a strong sense of responsibility and urgency.
- Participates in core process steps for systematic literature reviews including search, screen, data extraction, analysis, and synthesis of the literature for CER processes.
- This position requires the ability to interpret data from scientific literature and clinical studies and summarize the results and in a clear, concise, and scientifically accurate manner in the CER.
- Strong knowledge and experience in Professional Medical Writing (Medical/Clinical; Regulatory; and Safety).
- Preferably someone who has knowledge of the medical minimal invasive space or is a quick learner.
• Experience in medical device industry: 5 years minimum
• Clinical Affairs/Medical Writing: 3 years (Preferred)
• Bachelor’s (Required)
• Master's (Preferred)
• San Jose, CA
• Can work remote for 50-70% of the time.
• United States (Required)
• 6 months
Full Time Opportunity: