Senior Medical Writer, Clinical and Regulatory Strategic Communications (CRSC)

Role: Medical Writer within the Clinical and Regulatory Strategic Communications (CRSC) team, focusing on preparing high-quality regulated and public-facing clinical documents. Objectives: ensure compliance, clarity, and health literacy in documents supporting clinical development programs. Responsibilities: authoring, editing, and reviewing protocols, study reports, investigator’s brochures, informed consent forms, and registration summaries; collaborating with cross-functional teams; leading or participating in process improvement initiatives; mentoring less experienced writers; managing multiple projects under tight deadlines. Requirements: Bachelor's in life sciences, pharmacy, medicine, or related; 3+ years of medical writing experience, with expertise in clinical regulatory documents and understanding of regulatory guidelines and clinical development processes. Skills: strong scientific interpretation, project management, conflict resolution, and excellent communication skills; proficiency with technical tools like SharePoint and MS Office. Preferred: experience independently preparing regulatory documents, familiarity with GxP and ICH GCP, and leadership in process improvements. High-Value: focus on clinical regulatory documents across phases, with travel (~10%), and contribution to compliant, clear, and health-literacy-conscious content to support global clinical trials.