Senior Medical Writer: Lead Clinical Regulatory Docs

TransPerfect Translations International; Lisboa; Hybrid; EUR 45,000 - 65,000; Full time

Job summary

TransPerfect Translations International is seeking a senior medical writer to lead the planning and preparation of high-quality regulatory documents for clinical development. The role involves partnering with clinical teams across Development, Operations, Biostatistics, Regulatory, and Program Management to support drug development under tight timelines.

You will drive timelines, templates, and standardised content while coordinating client contributors and internal resources to ensure timely

Qualifications

• 5+ years of medical writing experience in CRO/biotech/pharma.
• 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.
• Familiarity with ICH and regulatory requirements; some ex-US knowledge desirable.
• Excellent written and verbal English communication.

Responsibilities

• Lead document execution and project timelines.
• Coordinate cross-functional client contributors and internal resources.
• Ensure document development adheres to client processes and templates.
• Serve as expert on client document management systems and tools.
• Lead document message development in collaboration with client.
• Interpret data and create shell documents to support authoring.
• Plan and lead kickoff meetings.
• Facilitate resolution of review feedback and plan comment resolution meetings.
• Follow up with team members to resolve outstanding feedback.
• Ensure consistency among programs in messaging, formatting, and presentation.
• Conduct literature searches as needed.
• Perform peer QC review as needed.
• Contribute to medical writing operational initiatives (templates, style guides, reference management).

Skills

Medical writing

Project management

Cross-functional collaboration

English communication

Education

Bachelor's degree or higher

Tools

Microsoft Word

Document management systems

Job description

TransPerfect Translations International is seeking a senior medical writer to lead the planning and preparation of high-quality regulatory documents for clinical development. The role involves partnering with clinical teams across Development, Operations, Biostatistics, Regulatory, and Program Management to support drug development under tight timelines.

You will drive timelines, templates, and standardised content while coordinating client contributors and internal resources to ensure timely