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

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 (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

Your profile

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

About us

Immunic 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.