Lead Medical Writer

• Lead the development and execution of medical writing strategies for clinical research projects
• Own medical writing deliverables and apply expertise to complex challenges
• Prepare, review, and edit clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and regulatory submissions
• Collaborate with clinical research, biostatistics, regulatory affairs, and medical affairs teams
• Interpret and analyze clinical trial data and summarize scientific findings
• Participate in planning and execution of clinical development programs
• Provide strategic input and scientific expertise for the design, conduct, and interpretation of clinical studies and research initiatives
• Develop publication plans, abstracts, posters, and manuscripts for peer-reviewed journals and scientific conferences
• Mentor and coach junior medical writers on best practices, writing techniques, and scientific principles

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Proficiency in interpreting and summarizing complex clinical trial data, scientific research findings, and statistical analyses
• Excellent writing, editing, and proofreading skills
• Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications
• Experience in interacting with regulatory agencies during the review and approval process
• Ability to work effectively in a fast-paced, deadline-driven environment
• Ability to manage multiple projects simultaneously and prioritize tasks based on project timelines and deliverables
• Excellent interpersonal and communication skills
• Ability to collaborate effectively with cross-functional teams, build relationships with key stakeholders, and influence decision-making processes
• Legal right to work in the country where the role is based

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways