Senior Consultant - Medical Writing, Clinical NDA modules
Location
United States + 42 moreAll locations: United States, United Kingdom, Germany, France, Estonia, Portugal, Hungary, Poland, Ukraine, Romania, Bulgaria, Czech Republic, Slovakia, Belarus, Moldova, Republic Of, Sweden, Greece, Belgium, Italy, Ireland, Switzerland, Netherlands, Finland, Malta, Denmark, Lithuania, Croatia, Spain, Austria, Bosnia And Herzegovina, Iceland, Luxembourg, Macedonia, The Former Yugoslav Republic Of, Montenegro, Norway, Serbia, Slovenia, Albania, Cyprus, Latvia, Monaco
Posted
10 days ago
Salary
Not specified
No structured requirement data.
Job Description
Role Description
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 (efficacy and safety)
- Support our medical experts as lead medical writer
- Provide project management for NDA submission modules 5 and 2 (clinical sections)
- Interact with internal and external reviewers
Time commitment: 40 h / week
Project duration: appr. 12 months, extension possible
Qualifications
- 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
Company Description
Job 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
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