Senior Consultant – Medical Writing, Clinical NDA modules
Immunic Therapeutics
contract
Posted on:
Location Type: Hybrid
Location: Anywhere in North America
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Job Level
About the role
- Support medical writing activities in connection with NDA submission by writing clinical modules (efficacy and safety)
- Collaborate with internal team members on NDA preparation
- 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
- 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 clinical modulesregulatory writingdrug development processesdocument formatting standards
Soft Skills
project managementcollaborationproactive approachsolution-focused mindsetleadership