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

We 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 writer
• Provide project management for NDA submission modules 5 and 2 (clinical sections)
• Interact with internal and external reviewers

Time commitment: 40h / week
Project duration: appr. 12 months, extension possible

• Solid experience in writing NDA / MAA / eCTD clinical modules strictly required
• Medical or science degree with substantial medical / regulatory writing experience in Biotech or Pharma
• Native-level English proficiency
• Strong understanding of drug development processes, regulatory interactions, and applicable global regulations (especially US FDA)
• Proficient with relevant software tools, style guides, and document formatting standards
• Excellent project management incl. leading cross-functional, international teams
• Collaborative and proactive approach, and solution-focused mindset