
5001 - 10000 employees
đŒ Consulting
âïž Legal
đŁ Marketing
Consulting âą Legal âą 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 lifeâsciences 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.
đ„ 1 hour ago
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5001 - 10000 employees
đŒ Consulting
âïž Legal
đŁ Marketing
Consulting âą Legal âą 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 lifeâsciences 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.
âą Lead the planning and preparation of high-quality clinical regulatory documents âą Produce protocols, publications, study reports, investigator brochures, narratives, and module documents according to client and agency guidelines âą Lead document execution and project management tasks, including creating, maintaining, and communicating timelines âą Coordinate cross-functional client contributors, stakeholders, and internal resources such as quality control and publishing âą Ensure document development follows client processes, templates, and instructional documents âą Serve as an expert on client document management systems, tools, templates, and procedures âą Lead document message development with clients âą Interpret data and create shell documents to support authoring âą Plan and lead kickoff meetings âą Facilitate review feedback resolution, including comment resolution meetings âą Follow up with team members to resolve outstanding review feedback âą Ensure consistency across client programs in messaging, formatting, and document presentation âą Conduct literature searches as needed âą Perform peer quality-control reviews as needed âą Contribute to medical writing operational initiatives such as templates, style guides, and reference management
âą 5+ years of experience as a medical writer in the CRO/biotech/pharmaceutical field âą Bachelorâs degree or higher in a relevant field âą Oncology, Infectious Disease, or Vaccine experience desired âą Experience writing clinical study reports, protocols, protocol amendments, investigator brochures, Module 2, and Module 5 documents desired âą Flexibility to work across multiple therapeutic areas, if needed âą Experience writing documents according to established processes and document templates âą Familiarity with lean authoring approaches and structured content management âą Familiarity with ICH and US regulatory requirements; working knowledge of ex-US regulatory requirements desired âą Expertise with Microsoft Word and other Microsoft applications âą Experience developing documents using document management systems, collaborative authoring tools, and review tools âą Comfortable adapting to new tools and technologies, if needed âą Ability to work independently and collaboratively amid competing priorities âą Service-oriented and proactive approach to project management âą Excellent conflict management and negotiation skills âą Comfortable providing suggestions based on previous experience âą Strong written and verbal communication skills in English âą Based in France and legally authorized to work there
âą Equal employment opportunity regardless of race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law âą Permanent, fixed-term, and freelance/contractor employment arrangements are available options
Apply Nowđ„ 1 hour ago
Senior Medical Writer producing clinical regulatory documents for TransPerfectâs global language-services business. Leading authoring, cross-functional coordination, review resolution, and quality-focused delivery.