[Hiring] Senior Regulatory Writing Specialist @Med Communications International

Role Description

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 will work directly with client teams to manage regulatory writing projects.

Qualifications

• 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 in English (C1 or C2)
• Clinical regulatory experience

Requirements

• Regulatory writing skills with mastery of 3 or more regulatory document types (e.g., clinical study protocols, clinical study reports, briefing documents, IND, NDA, and MAA components)
• Solid understanding of and ability to apply statistical, regulatory, and medical communication concepts needed to independently write regulatory documents in more than 1 therapeutic area
• Manages at least 3 single-document projects simultaneously
• Working knowledge of relevant regulatory guidance (e.g., ICH, FDA, EMA) for clinical trial conduct, including document-specific guidance
• Acts as a primary writer and/or project manager for key documents and projects
• Ensures document accuracy, completeness, and consistency of messaging
• Organizes and leads cross-functional document review meetings, clarifies and incorporates feedback
• Works with cross-functional subject matter experts to resolve unclear comments and differences of opinion between functional areas
• Performs document-level QC (including abbreviations, references to sources, data in text versus data in tables, figures, or graphs, etc.) and writer peer review (logical flow, sense check, etc.)
• Leads project-level management activities, i.e., timeline preparation and oversight and meeting scheduling
• Participates in guiding less experienced writers on those documents for which they have expertise
• Proactively contributes to improvements to medical writing processes
• Understands, complies with, and contributes to the updates of SOPs, templates, best practices, policies, and regulatory writing style guides
• Develops project-level lexicons and conventions

Benefits

• Remote work opportunity
• Location: Remote Brazil

Company Description

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, genetic information, or veteran status.