Job Description

Overview In this role you will lead medical writing projects for Clinical Research Scientists, Academic partners, Sponsors and/or the Corporation. Interpret and translate complex technical research methodologies, data, or messaging into clinical development plans and regulatory documents (protocols, informed consent forms, investigator brochures, clinical study reports, etc.) and/or presentations on a timely basis and in a manner that aligns with industry and regulatory content guidelines and standards. Embrace a continuous learning mindset and be able to manage writing projects of high complexity, including those stemming from studies with novel or innovative research designs. Critical thinking, diplomacy, and the ability to interact effectively with global key opinion leaders and to proactively suggest improvements to ensure timely document progression. Coordinate document reviews with authors. Develop and track timelines for assigned writing projects. Provide mentorship and supp...

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