Senior Consultant supporting Medical Writing activities for NDA submission. Collaborating and managing clinical modules for regulatory submissions at Immunic Therapeutics.
Responsibilities
Support Medical Writing activities in connection with a NDA submission
Collaborate with internal team members on our NDA preparation by writing clinical modules (efficacy and safety)
Support medical experts as lead medical writer
Provide project management for NDA submission modules 5 and 2 (clinical sections)
Interact with internal and external reviewers
Requirements
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
Benefits
Hybrid/Remote work arrangements
Project duration: appr. 12 months, extension possible
Job title
Senior Consultant – Medical Writing, Clinical NDA modules
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