Medical Writer - Senior Regulatory Writing Specialist (Clinical)

Job description

Medical Writer - Senior Regulatory Writing Specialist (Clinical) Essentials: - 3+ years of regulatory writing experience (actual writing, not just a contributor) - Experience with at least 3 different regulatory documents (including but not limited to: clinical study reports, protocols, Investigators Brochures, briefing documents, Module 2 documents) - Client-facing experience/project management experience - Excellent attention to detail MS Word expertise - Experience with quality control (QC) review - Fluent: C1 or C2 - English language - Clinical regulatory experience - Location: Remote Brazil  Nice-to-Have: - PhD, PharmD, or MD - Nonclinical (or preclinical) writing experience (Module 2.4 or Module 4 documents) - Science or research experience (PhD/PharmD not required, but some scientific or research experience is helpful) - Experience with platforms such as Veeva Vault, Sharepoint, or PleaseReview Basic understanding of statistics POSITION SUMMARY: The Senior Regulatory Writing Specialist is a professional responsible for the creation of regulatory materials for investigational and marketed products in alignment with regulatory and compliance practices. The individual...