Immunic Therapeutics

Senior Consultant – Medical Writing, Clinical Pharmacology

Immunic Therapeutics

full-time

Posted on:

Location Type: Hybrid

Location: Anywhere in Europe

Visit company website

Explore more

✨ AI Apply
Apply

Job Level

Senior

About the role

  • Support Medical Writing activities in connection with NDA submission
  • Collaborate with internal team members on NDA preparation by writing clinical modules (AMDE, DDI, FE/FA, BE, TQT, COC)
  • Provide project management for clinical pharmacology modules
  • Interact with non-clinical pharmacology experts, internal and external reviewers

Requirements

  • 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
Benefits
  • Flexible work arrangements
  • Professional development
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
NDA writingMAA writingeCTD writingclinical pharmacologyPhase 1 studyregulatory writingdrug development processesdocument formatting standards
Soft Skills
project managementcollaborationproactive approachsolution-focused mindsetleadershipcommunication
Certifications
medical degreescience degree