Senior Medical Writer

About the role

TransPerfect is looking for an organized, motivated and collaborative Senior Medical Writer for its medical writing team in Madrid. The writer partners cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory and Program Management to plan and prepare high-quality clinical regulatory documents, such as protocols, publications, study reports, investigator brochures, narratives and module documents, within brisk timelines.

Key responsibilities

• Lead the execution of documents, including project management tasks such as creating, maintaining and communicating timelines
• Coordinate cross-functional client contributors and stakeholders, as well as internal resources such as quality control and publishing, to ensure timely completion
• Ensure documents follow client processes, templates and instructional documents, and act as an expert on the client document management system and related tools
• Lead document message development with the client, interpret data and create shell documents to support authoring
• Plan and lead kickoff meetings and comment resolution meetings, curating review comments so they run efficiently, and follow up with team members on outstanding feedback
• Ensure consistent messaging, formatting and presentation across client programs
• Conduct literature searches, perform peer QC reviews and contribute to operational initiatives such as templates, style guides and reference management

Required profile

• 5+ years of experience as a medical writer in the CRO, biotech or pharmaceutical field
• Bachelor's degree or higher in a relevant field
• Experience writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2 and module 5 documents
• Oncology, infectious disease or vaccine experience desired; flexibility across therapeutic areas desired
• Working knowledge of ICH and US regulatory requirements; familiarity with ex-US requirements desired
• Strong written and verbal communication skills in English

Required skills

• Microsoft Word and other Microsoft applications
• Document management systems, collaborative authoring tools and review tools
• Familiarity with lean authoring approaches and structured content management
• Project management, conflict management and negotiation skills