[Hiring] Medical Writer - 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.

• 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 the 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.

Qualifications

• Advanced degree in a scientific discipline (e.g., life sciences, pharmacy, medicine) or relevant work experience; or equivalent combination of education, training, and experience.
• More than 2 years (typically 3-5 years) of experience in scientific/medical/regulatory writing in the pharmaceutical domain.

Requirements

• Fluent in English (C1 or C2).
• Proficient in Microsoft Word, Excel, PowerPoint, and Outlook, and quickly able to learn new software.
• Ability to apply regulatory guidelines to content development.
• Above average attention to detail, teamwork, and initiative.
• Ability to interact with other departments within the company and be proficient in written and verbal communication.

Benefits

• Remote work opportunity.