The Sr./Medical Writer is responsible for authoring and coordinating the review of complex clinical and scientific documents supporting the Medical Affairs, Clinical Development, Regulatory, and Clinical Operations teams. S/he supports the Fractyl DMR (Duodenal Mucosal Resurfacing) program for the treatment of metabolic diseases by authoring and providing QC to manuscripts, clinical study reports, clinical evaluation reports, safety summaries, protocols/amendments, Investigator Brochure, and other documents related to the clinical program such as support for medical affairs communications and regulatory submissions. The Sr. Medical Writer applies scientific knowledge, analytical skills, and technical writing skills to all assignments, producing high quality and timely deliverables while ensuring scientific consistency between related documents or studies in clinical programs.
This position requires up to 5% travel, as needed.
The description and requirements outlined above are general; additional requirements may apply.
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