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

Hybrid / Remote

Full or part-time

Freelancer

Your mission

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

Your profile

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

Über uns

Immunic Therapeutics ist ein dynamisches Biotechnologieunternehmen mit einem Portfolio selektiver, oral verfügbarer Immuntherapien zur Behandlung von chronischen entzündlichen und autoimmunen Erkrankungen. Derzeit befinden sich drei Wirkstoffkandidaten in verschiedenen Phasen der klinischen Entwicklung. Weitere Informationen dazu sind auf unserer Homepage zu finden: www.imux.com.