Overview
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In this role you drive high-quality regulatory and clinical documents, leading writing workstreams and cross-functional collaboration to support major submissions. You guide best practices, mentor junior writers, and stay aligned with evolving regulatory standards. You act as the lead writer on complex projects, shaping regulatory submissions for biologics and drugs. This position combines leadership with hands-on writing to ensure timely, compliant outcomes.
Compensaciones / Ventajas
competitive base salary; performance incentives
health and wellbeing programmes (medical, dental, vision)
retirement and pension plans
life assurance and disability coverage
employee assistance programmes and wellbeing resources
learning and development opportunities
Responsabilidades
Oversee medical writing workstreams and ensure deliverables meet quality and timelines
Lead preparation and review of clinical study reports, protocols, and regulatory documents for accuracy and clarity
Collaborate with clinical research, biostatistics, and regulatory affairs to gather and synthesize information
Provide guidance on best practices and regulatory requirements; uphold internal standards




Mentor and train junior medical writers to foster excellence and growth
Stay current with industry trends and regulatory guidelines to inform writing
Act as lead medical writer for complex projects and manage regulatory submission writing for major biologics and drugs
Perform all duties of Senior Medical Writer and lead regulatory submission writing when required
Requisitos principales
Bachelor's degree in life sciences, pharmacy, or related discipline
Significant medical writing experience with regulatory submissions and clinical documentation
Strong understanding of regulatory requirements and industry xqbhyrx standards for clinical writing
Exceptional writing and editing skills with attention to detail
≥5 years in pharma/biotechnology writing; 3+ years in electronic documents and submissions
Experience with key documents in major international regulatory submissions (CSR, IBs, Protocols)
Experience managing writing activities for major international regulatory submissions
excellent written and verbal communication
mentoring and leadership
cross-functional collaboration
regulatory writing for clinical and regulatory submissions
clinical study reports (CSRs)
investigator's brochures (IBs)

📌 Principal Medical Writer (Barcelona)
🏢 Icon Clinical
📍 Barcelona