Senior Medical Writer

Job not on LinkedIn

đŸ”„ 56 minutes ago

đŸ‡«đŸ‡· France – Remote

⏰ Full Time

🟠 Senior

đŸ„đŸ“ Medical Writer

đŸ‘» Ghost score 10%

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Logo of TransPerfect

TransPerfect

5001 - 10000 employees

đŸ’Œ 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 according to client and agency guidelines ‱ Lead document execution, 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 and lead comment resolution meetings ‱ Follow up with team members to resolve outstanding feedback ‱ Ensure consistency in messaging, formatting, and presentation across client programs ‱ Conduct literature searches as needed ‱ Perform peer QC review 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 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, 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 authorised 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 law

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