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.

• 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 Share Point
• 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

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.

• Clinical Regulatory Document Preparation
• Team Leadership in Medical Writing
• Critical Thinking and Problem Solving
• Microsoft Office Suite Proficiency
• Knowledge of ICH GCP Guidelines

• Medical Writing
• Clinical Study Reports
• Informed Consent Forms
• Regulatory Submissions
• Project Management
• Document Review
• Conflict Resolution
• Data Interpretation
• Process Improvements
• Negotiation

• Oral Communication
• Written Communication
• Presentation Skills
• Adaptability
• Mentoring

• Regulatory Compliance
• Clinical Development
• Life Sciences
• Pharmacy
• Public Health

• Share Point
• Document Management Systems
• Medical Writing Tools