Overview 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 / Beneficioscompetitive base salary; performance incentiveshealth and wellbeing programmes (medical, dental, vision)retirement and pension planslife assurance and disability coverageemployee assistance programmes and wellbeing resourceslearning and development opportunities ResponsabilidadesOversee medical writing workstreams and ensure deliverables meet quality and timelinesLead preparation and review of clinical study reports, protocols, and regulatory documents for accuracy and clarityCollaborate with clinical research, biostatistics,



and regulatory affairs to gather and synthesize informationProvide guidance on best practices and regulatory requirements; uphold internal standardsMentor and train junior medical writers to foster excellence and growthStay current with industry trends and regulatory guidelines to inform writingAct as lead medical writer for complex projects and manage regulatory submission writing for major biologics and drugsPerform all duties of Senior Medical Writer and lead regulatory submission writing when required Requisitos principalesBachelor's degree in life sciences, pharmacy, or related disciplineSignificant medical writing experience with regulatory submissions and clinical documentationStrong understanding of regulatory requirements and industry standards for clinical writingExceptional writing and editing skills with attention to detail≥5 years in pharma/biotechnology writing; 3+ years in electronic documents and submissionsExperience with key documents in major international regulatory submissions (CSR, IBs, Protocols)Experience managing writing activities for major international regulatory submissionsexcellent written and verbal communicationmentoring and leadershipcross-functional collaborationregulatory writing for clinical and regulatory submissionsclinical study reports (CSRs)investigator's brochures (IBs)

📌 Principal Medical Writer - barcelona
🏢 Jobrapido
📍 Barcelona