Immunic AG

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description 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 (AMDE, DDI, FE/FA, BE, TQT, COC) - Support our clinical pharmacology experts as lead medical writer - Provide project management for clinical pharmacology modules - Interact with non-clinical pharmacology experts, internal and external reviewers Time commitment: 32h / week Project duration: appr. 12 months Qualifications - Solid experience in writing NDA / MAA / eCTD clinical modules and clinical pharmacology / Phase 1 study 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 Company Description

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description 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: 40 h / week Project duration: appr. 12 months, extension possible Qualifications - 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 Company Description