Senior Medical Writer

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đŸ”„ 1 hour ago

đŸ‡«đŸ‡· France – Remote

⏰ Full Time

🟠 Senior

đŸ„đŸ“ Medical Writer

đŸ‘» Ghost score 11%

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Logo of TransPerfect

TransPerfect

5001 - 10000 employees

đŸ’Œ 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 the planning and preparation of high-quality clinical regulatory documents ‱ Produce protocols, publications, study reports, investigator brochures, narratives, and module documents according to client and agency guidelines ‱ Lead document execution and project management tasks, including creating, maintaining, and communicating 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, including comment resolution meetings ‱ Follow up with team members to resolve outstanding review feedback ‱ Ensure consistency across client programs in messaging, formatting, and document presentation ‱ 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, if needed ‱ Experience writing documents according to established processes and document 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 developing documents using document management systems, collaborative authoring tools, and review tools ‱ Comfortable adapting to new tools and technologies, if needed ‱ Ability to work independently and collaboratively amid competing priorities ‱ Service-oriented and proactive approach to project management ‱ Excellent conflict management and negotiation skills ‱ Comfortable providing suggestions based on previous experience ‱ Strong written and verbal communication skills in English ‱ Based in France and legally authorized to work there

đŸ–ïž Benefits

‱ 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 ‱ Permanent, fixed-term, and freelance/contractor employment arrangements are available options

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Senior Medical Writer producing clinical regulatory documents for TransPerfect’s global language-services business. Leading authoring, cross-functional coordination, review resolution, and quality-focused delivery.