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Sr. IVD Medical Writer for Leica Biosystems Richmond, Inc. in Richmond, IL to collaborate with LBS Global Clinical Affairs leadership to Collaborate with Clinical Program Leads and relevant departments (R&D, Regulatory Affairs, Product Support, Program Management, Marketing) to aid in design and preparation of clinical and analytical performance study plans, protocols, and reports, statistical data analysis plans, and associated study data collection forms. Lead in the provision of medical and scientific writing services to support LBS Global Clinical Affairs activities around IVD development, registration and marketing; Produce clinical study plans, protocols, and reports for clinical affairs regulatory submission deliverables in addition to other pre/post-market documentation; Conduct in-depth literature searches following established operating company policies/ procedures as an input to accomplishing clinical study plans, protocols, and reports; Own and coordinate the review process for reports, manuscripts, and other written communications. Represent the LBS Global Clinical Affairs team on multi-functional core teams to ensure project requirements are met and trials are conducted successfully.

Requires: Master\'s degree in Biology, Biotechnology or related life sciences field (willing to accept foreign education equivalent) plus four (4) years as a Scientist or related occupation involving research or medical writing capacity within in vitro diagnostic or medical device industry. Alternatively, a PhD in Biology, Biotechnology or related life sciences field (willing to accept foreign education equivalent) and two (2) years of experience as a Scientist or related occupation involving research or medical writing capacity within in vitro diagnostic or medical device industry. Experience must include creating clinical articles, datasets, and reports in terms of clinical performance; Medical writing; and Writing IVDR Clinical Performance Reports, Literature Search Reports, and Scientific Validity Reports; Literature Search Reports; and Scientific Validity Reports. Remote position - May work from anywhere in U.S. Submit resume to latoya.loving@leicabiosystems.com & reference job title.