Senior Medical Writer | Spain
Core
Lead the planning and preparation of high-quality clinical regulatory documents to support drug development.
Role type
Senior Medical Writer (Clinical Development)
Builds
Clinical regulatory documents (protocols, study reports, investigator brochures, narratives, module documents)
Domain
Biopharmaceuticals / Clinical Research
Required skills
Project management, Cross-functional coordination, Document management systems, Literature search, Peer QC review, ICH/US regulatory knowledge, Microsoft Word, Collaborative authoring tools
Preferred skills
Oncology, Infectious Disease, or Vaccine experience; Clinical study reports, protocols, module 2/5 writing; ex-US regulatory knowledge; Lean authoring approaches
Responsibilities
Lead document execution and project management; Coordinate cross-functional contributors and stakeholders; Ensure adherence to client processes and templates; Lead document message development; Interpret data and create shell documents; Plan and lead kickoff meetings; Facilitate resolution of review feedback; Conduct literature searches; Perform peer QC review; Contribute to operational initiatives (templates, style guides)
Seniority
Senior, hands-on IC
