Senior Medical Writer

• Lead the development and execution of medical writing strategies for clinical research projects
• Independently produce clinical and regulatory documents in collaboration with Principal/Senior Principal Medical Writers
• Develop documents including Clinical Study Protocols and Clinical Study Reports across Phase 1 to Phase 3 and multiple therapeutic areas
• Analyze and critically interpret data to determine the best approach to composing each document
• Apply lean writing strategies
• Act as the primary contact for study teams regarding document preparation, planning, and timelines
• Facilitate document reviews and ensure documents are submission-ready and finally approved
• Collaborate directly with QC personnel and publishing specialists during document preparation
• Mentor and coach junior medical writers on best practices, writing techniques, and scientific principles
• Foster excellence, collaboration, and continuous learning within the medical writing team

• 3-5 years of experience as regulatory writer
• Mandatory protocol writing experience in Phase II or III
• CSR experience is good to have
• 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, including ICH-GCP, FDA, and EMA, governing the preparation and submission of clinical documents and publications
• Experience interacting with regulatory agencies during the review and approval process
• 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