Regulatory Writer - Remote

Job DescriptionWe are currently partnering with a leading global medical communications agency to support their search for an experienced Regulatory Medical Writer. This is a fantastic opportunity to contribute to meaningful regulatory submissions across a variety of therapeutic areas, working with a highly collaborative and well-established team.About the Role:This position involves the development of high-quality, accurate, and compliant documentation to support global regulatory submissions. You will work closely with internal teams and external clients to ensure that deliverables meet both scientific and regulatory standards.Key Responsibilities:Write and edit a variety of regulatory documents (e.g., clinical study reports, protocols, CTD clinical summaries, investigator brochures) across multiple therapeutic areasEnsure all documents are clear, accurate, and aligned with relevant regulatory guidelines and client expectationsReview and quality-check clinical documentation, data outputs, and other supporting materialsLiaise with client teams to manage timelines, address queries, and resolve content or compliance issuesConduct background research to confirm references and stay aligned with current regulatory requirementsWork across multiple projects while maintaining high standards and meeting deadlinesRequirements:Previous experience producing regulatory documentation within a medical communications agency or pharmaceutical environmentStrong understanding of regulatory writing standards and processes (e.g., ICH, GCP)Life sciences degree (advanced degree preferred)High attention to detail, critical thinking, and the ability to work independently or as part of a teamExperience with reviewing protocols, statistical analysis plans, and clinical dataExcellent verbal and written communication skillsWhats on Offer:This role offers the opportunity to work in a high-impact environment with a global client base, excellent support systems, and the ability to work remotely or flexibly. You will also benefit from structured career development, internal training, and a strong culture of collaboration and professionalism.

Created: 2025-06-27