Senior Medical Writer

Job not on LinkedIn

🔥 3 minutes ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 11%

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Logo of TransPerfect

TransPerfect

5001 - 10000 employees

💼 Consulting

⚖️ Legal

📣 Marketing

Consulting • Legal • Marketing

TransPerfect is a global language and technology company that provides translation, localization, interpretation, and content services combined with software and AI-powered tools such as the GlobalLink translation management platform. It offers multilingual marketing, legal and life‑sciences regulatory support, contact center/BPO services, multimedia localization, and solutions for website, software and app globalization. TransPerfect serves large enterprise and Fortune 500 clients across dozens of industries and supports content in 200+ languages.

📋 Description

• Lead execution of clinical regulatory documents and related project management tasks • Create, maintain, and communicate project timelines • Coordinate cross-functional client contributors, stakeholders, and internal resources such as quality control and publishing • Ensure document development follows client processes, templates, and instructional documents • 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 to support authoring • Plan and lead kickoff meetings • Facilitate review feedback resolution and lead comment resolution meetings • Curate review comments and follow up with team members on outstanding feedback • Ensure consistency in messaging, formatting, and presentation across client programs • Conduct literature searches as needed • Perform peer quality-control reviews as needed • Contribute to medical writing operational initiatives such as templates, style guides, and reference management

🎯 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 document templates • Familiarity with lean authoring approaches and structured content management • Familiarity with requirements for key clinical and regulatory documents, including ICH and US regulatory requirements • Working knowledge of ex-US regulatory requirements desired • Expertise with Microsoft Word and other Microsoft applications • Experience developing documents using document management systems, collaborative authoring tools, and review tools • Comfortable adapting to new tools and technologies • Ability to work independently and collaboratively amid competing priorities • Service-oriented and proactive approach to project management • Conflict management and negotiation skills • Strong written and verbal communication skills in English • Must be based in Brazil and legally authorized to work there

🏖️ Benefits

• Full-time, permanent employment arrangement • Equal employment opportunity • Remote work arrangement in Brazil • Opportunity to work with cross-functional client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management

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