Senior Consultant (m/f/x) - Medical Writing, Clinical NDA modules

Your missionWe are looking for a Consultant (m/f/x) to support our Medical Writing activities in connection with a NDA submission. This assignment can be done remotely from the EU, UK or US (preferably East Coast), and includes:Collaboration with our internal team members on our NDA preparation by writing clinical modules (efficacy and safety)Support our medical experts as lead medical writerProvide project management for NDA submission modules 5 and 2 (clinical sections)Interact with internal and external reviewersTime commitment: 40h / weekProject duration: appr. 12 months, extension possibleYour profileSolid experience in writing NDA / MAA / eCTD clinical modules strictly requiredMedical or science degree with substantial medical / regulatory writing experience in Biotech or PharmaNative-level English proficiencyStrong understanding of drug development processes, regulatory interactions, and applicable global regulations (especially US FDA)Proficient with relevant software tools, style guides, and document formatting standardsExcellent project management incl. leading cross-functional, international teamsCollaborative and proactive approach, and solution-focused mindset#J-18808-Ljbffr