Retirement RFP Writer boosting National Life Group’s growth through high - quality proposals and strategic planning. Contributes to client retention and new business acquisition in retirement markets.
About the role
- Senior Consultant supporting Medical Writing activities for NDA submission. Collaborating and managing clinical modules for regulatory submissions at Immunic Therapeutics.
Responsibilities
- Support Medical Writing activities in connection with a NDA submission
- Collaborate with internal team members on our NDA preparation by writing clinical modules (efficacy and safety)
- Support medical experts as lead medical writer
- 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
- Hybrid/Remote work arrangements
- Project duration: appr. 12 months, extension possible
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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