Immunic AG
Senior Consultant (m/f/x) - Medical Writing, Clinical Pharmacology
TLDR
Support medical writing activities for NDA submissions, providing project management for clinical pharmacology modules while collaborating with regulatory experts and internal teams.
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
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
Immunic AG is dedicated to improving patient care through pioneering research in the healthcare sector. We create innovative solutions that address critical needs and enhance treatment outcomes for patients.
Consultant