Overview
In this role you will be an integrated member of sponsor teams, delivering medical writing for clinical documents across CTRs, TDOs/CTPs, IBs, biomarker reports, and submission documents. You will work within sponsor processes to manage timelines, QC, and document formatting, ensuring regulatory alignment. The focus is on eye health and inflammation, with senior-level experience preferred. You will collaborate across functions to shape high-quality submissions and strategic input, contributing to robust clinical documentation.
Verantwortungsbereiche
- Set up and manage clinical documents in the EDMS
- Review and approve Statistical Analysis Plans in the EDMS
- Plan and finalize timelines with trial/project teams
- Prepare and participate in trial team and submission meetings
- Prepare and conduct kick-off meetings for TDO/CTP, IB, CTR writing
- Draft documents with appropriate tables/figures per timelines
- Coordinate review cycles, integrate feedback, and finalize documents
- Perform QC checks and complete QC documentation
- Publish and pre-archive checks, monitor findings
- Provide final document versions to trial/project teams
- Conduct e-approval of final documents in the EDMS
- Perform technical checks after IB drafts and updates
- Follow sponsor SOPs for document processes
Zentrale Anforderungen
- Bachelor-level degree in scientific/clinical/regulatory field plus ~5 years medical writing experience in biopharma/CRO
- Strong regulatory knowledge (ICH, FDA, EMA) across clinical development
- Ability to lead writing for complex documents and provide strategic input
- Excellent written and verbal communication skills
- Strong organizational, time management, and project management skills
- Ability to work cross-functionally and independently
- High attention to detail and scientific accuracy
- Proficiency in Microsoft Word and document formatting
- Experience with electronic document management systems (eDMS) and templates/style guides
- strong communication
- cross-functional collaboration
- attention to detail
- Microsoft Word
- Electronic Document Management System (EDMS)
- document formatting best practices
Senior/ Medical Writer - FSP (M/W/D) in Wiesbaden Arbeitgeber: IQVIA
IQVIA ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in New Orleans die Möglichkeit bietet, in einem dynamischen und unterstützenden Umfeld zu arbeiten. Mit einem starken Fokus auf berufliche Weiterentwicklung und einem flexiblen Arbeitsmodell fördert das Unternehmen eine positive Work-Life-Balance und ermöglicht es den Flex Nurse Educators, Patienten durch innovative Bildungsansätze zu unterstützen. Die Unternehmenskultur legt Wert auf Teamarbeit und Vielfalt, was IQVIA zu einem attraktiven Arbeitsplatz für engagierte Fachkräfte macht.
