Cactus Hiring Scientific Writer, Clinical Evaluation Reports (CER)
Responsibilities:
· Ensure timely production of high quality CERs for devices across therapeutic areas
· Screen and summarize literature for relevant clinical data
· Review literature to elucidate the clinical problem and current treatment techniques
· Study and report device characteristics and instructions for use
· Evaluate data for similar competitor devices
· Summarize post-marketing surveillance and risk management data for the target device
· Work with senior writers to prepare documents that meet client expectations in terms of content, format, and presentation
Requirements (Desired skills & experience):
· MD, PhD in Biomedical Engineering or a similar degree with knowledge of clinical research, and first-author publications in international peer-reviewed journals
· A Master’s degree with clinical research exposure and significant publications experience can also be considered
· 1-2 years of regulatory writing experience, with some exposure to medical devices
· Ability to understand and interpret complex clinical trial data
· Clear, concise scientific style of writing with a high level of attention to detail
· Excellent written and oral English language skills
· Be self-motivated and eager to take on challenges
· Ability to work under tight timelines and manage multiple tasks