Google Ad

Senior Regulatory Medical Writer - Home Based

r Regulatory Medical Writer Write clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, integrated summaries of safety and efficacy. Extensive clinical/scientific writing skills. Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. Minimum Work Experience 5+ years regulatory medical writing experience: experience in writing multiple clinical study reports, NDA submissions, Protocols, Narratives, Case Report Studies, and Inform Consent forms.

Warwick, Rhode Island