Senior Proposal Writing Specialist responsible for developing customer - focused proposals at Highmark Health. Collaborating with stakeholders to create messaging that meets sales objectives and customer needs.
About the role
- Consultant in Medical Writing for NDA submissions at Immunic Therapeutics, providing writing and project management support. Collaborating with clinical pharmacology experts and internal teams.
Responsibilities
- Support our Medical Writing activities in connection with a NDA submission
- 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
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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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