Senior Medical Writer, Clinical and Regulatory Strategic Communications

Prepare clinical regulatory documents including protocols, clinical study reports, participant narratives, and investigator's brochures Prepare public-facing documents including informed consent forms, clinical trial registration and results postings, and plain language summaries Design, plan, author, edit, and review accurate, clear, high-quality documents Contribute scientifically and collaborate on document-specific cross-functional teams Demonstrate team and project leadership responsibilities Apply critical thinking, problem solving, and negotiation to challenges across documents, content, processes, timelines, and tools Keep medical writing project leads and/or management informed and elevate issues affecting timelines, quality, or compliance Use medical writing-specific tools and technology platforms Participate in or lead initiatives improving medical writing processes and standards Apply knowledge of clinical development, relevant regulations, disease areas, and company products Support departmental needs such as orienting new team members and mentoring less experienced writers May manage direct reports, including workload, professional development, and performance management Demonstrates expertise in preparing clinical regulatory documents and public-facing materials while leading cross-functional teams. Possesses strong critical thinking, problem-solving, and communication skills essential for managing multiple projects in a deadline-driven environment. Requirements Bachelor's degree, preferably in a health, scientific, or relevant discipline (e.g., life sciences, pharmacy, medicine, public health) 3+ years of relevant medical writing or industry experience Experience managing multiple writing projects in a deadline-driven environment Experience leading teams of medical writers and/or cross-functional team members Ability to interpret clinical data clearly, objectively, and in accordance with regulatory requirements and industry guidelines, with minimal supervision Demonstrated critical thinking and problem-solving capabilities Experience with conflict resolution and negotiation in cross-functional teams Ability to adapt to changing project needs and unexpected workload demands Strong oral and written communication and presentation skills Technical expertise in Microsoft Office Suite and shared document systems such as SharePoint Willingness to learn and adapt to emerging technology Experience independently preparing clinical regulatory documents in accordance with regulatory requirements and industry guidelines Knowledge of ICH GCP Guidelines, regulatory compliance, regulatory documents, regulatory submissions, medical writing, process improvements, project management, and technology platforms No visa sponsorship No valid driving license required Core Competencies Demonstrates expertise in preparing clinical regulatory documents and public-facing materials while leading cross-functional teams. Possesses strong critical thinking, problem-solving, and communication skills essential for managing multiple projects in a deadline-driven environment. Highest-signal resume keywords Clinical Regulatory Document Preparation Team Leadership in Medical Writing Critical Thinking and Problem Solving Microsoft Office Suite Proficiency Knowledge of ICH GCP Guidelines ATS Optimization Keywords Hard Skills Medical Writing Clinical Study Reports Informed Consent Forms Regulatory Submissions Project Management Document Review Conflict Resolution Data Interpretation Process Improvements Negotiation Soft Skills Oral Communication Written Communication Presentation Skills Adaptability Mentoring Industry Keywords Regulatory Compliance Clinical Development Life Sciences Pharmacy Public Health Tools & Technologies SharePoint Document Management Systems Medical Writing Tools #J-18808-Ljbffr Jobtailor