Remote Lead Medical Writer - NDA & Clinical Pharmacology

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 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 reviewersYour 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 doneremotelyfrom 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 reviewersTime commitment:32h / weekProject duration:appr. 12 monthsYour profileSolid 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 About UsImmunic Therapeutics is a dynamic biotechnology company with a pipeline of selective, orally available immunology therapies for the treatment of chronic inflammatory and autoimmune diseases. Currently, three small molecule product candidates are in various stages of clinical development. For more information, please visit: www.imux.com. #J-18808-Ljbffr