Senior Medical Writer

Job not on LinkedIn

🔥 39 minutes ago

🇪🇸 Spain – Remote

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 10%

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Logo of TransPerfect

TransPerfect

5001 - 10000 employees

💼 Consulting

⚖️ Legal

📣 Marketing

💰 $425M Debt Financing - TransPerfect on 2025-04

Consulting • Legal • Marketing

TransPerfect is a global language services and technology company that provides translation, localization, interpretation, multilingual customer support (contact center/BPO), regulatory and labeling services, and creative/global marketing solutions. It combines human linguists with technology — notably the GlobalLink translation management platform and AI/machine‑translation capabilities — to help organizations launch and manage content, software, websites, and campaigns in multiple languages and markets. TransPerfect serves enterprise clients across industries such as life sciences, finance, legal, gaming, retail, and media.

📋 Description

• Lead planning and preparation of high-quality clinical regulatory documents • Produce protocols, publications, study reports, investigator brochures, narratives, and module documents • Lead document execution, including project management tasks and timeline communication • Coordinate cross-functional client contributors, stakeholders, and internal resources such as quality control and publishing • Ensure document development follows client processes, templates, and instructions • Serve as an expert on client document management systems, tools, templates, and procedures • Lead document message development with clients • Interpret data and create shell documents • Plan and lead kickoff meetings • Facilitate review feedback and comment resolution meetings • Follow up with team members to resolve outstanding review feedback • Ensure consistency in messaging, formatting, and presentation across client programs • Conduct literature searches • Perform peer quality-control reviews • Contribute to medical writing operational initiatives such as templates, style guides, and reference management • Partner cross-functionally with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management teams

🎯 Requirements

• 5+ years of experience as a medical writer in the CRO/biotech/pharmaceutical field • Bachelor’s degree or higher in a relevant field • Oncology, Infectious Disease, or Vaccine experience desired • Experience writing clinical study reports, protocols, protocol amendments, investigator brochures, Module 2, and Module 5 documents desired • Flexibility to work across multiple therapeutic areas • Experience writing documents according to established processes and templates • Familiarity with lean authoring approaches and structured content management • Familiarity with ICH and US regulatory requirements; working knowledge of ex-US regulatory requirements desired • Expertise with Microsoft Word and other Microsoft applications • Experience with document management systems, collaborative authoring tools, and review tools • Comfort adapting to new tools and technologies • Ability to work independently and collaboratively amid competing priorities • Service-oriented and proactive approach to project management • Excellent conflict management and negotiation skills • Strong written and verbal communication skills in English • Based in Spain and legally authorized to work in Spain

🏖️ Benefits

• Full-time, permanent employment • Equal employment opportunity regardless of protected characteristics

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