We're seekingan organized, motivated, and collaborative individual for our medical writing team.
Theseniormedical writer will partner cross-functionallywith client teams inClinical Development, Clinical Operations,Biostatistics,Regulatory, and Program Management inleading theplanning and preparation of high-quality clinical regulatory documents. The medical writer may produceprotocols, publications, study reports, investigator brochures,narratives,and module documents, according to clientand agency guidelines,to support drug development underbrisktimelines.
Responsibilities :
- Lead theexecution of documents, includingproject management tasks such ascreating,maintaining, and communicatingtimelines
- Coordinate cross-functional client contributors and stakeholders as well as internal resources (e.G., quality control [QC], publishing)to ensuretimelycompletion ofdocuments
- Ensuredocument developmentadherestoanyrelevantclient processes, templates, and instructionaldocuments
- Serve as an expert on client document management system and related tools, templates,



and procedures to ensure efficient documentdevelopment
- Lead document message development in collaboration withclient
- Interpret data and create shell documents to supportauthoring
- Plan and lead kickoffmeetings
- Facilitate resolution of review feedback including planningand leadingcomment resolution meetings(curate review comments to ensuremeetings areefficient)
- Follow-up with individual team members asneeded to resolve outstanding reviewfeedback
- Ensure consistency among client programs in terms of messaging, formatting, and presentation ofdocuments
- Conduct literature searches asneeded
- Perform peer QC review asneeded
- Contribute to medical writing operational initiatives (e.G., templates, style guides, reference management), if needed
- Experience (5+ years) as a medical writer in the CRO/biotech/pharmaceutical field
- Bachelor's degreeor higherin a relevant field
- Oncology, InfectiousDisease, or V

📌 Senior Medical Writer | Spain (Cataluña)
🏢 Transperfect
📍 Cataluña