Senior Medical Writer

Job not on LinkedIn

🔥 3 minutes ago

🇩🇪 Germany – Remote

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 11%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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TransPerfect

WebsiteLinkedInAll Job Openings

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 the planning and preparation of high-quality clinical regulatory documents • Partner cross-functionally with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management client teams • Produce protocols, publications, study reports, investigator brochures, narratives, and module documents • 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 and lead comment resolution meetings • Follow up with team members to resolve outstanding review feedback • Ensure consistency across client programs in document messaging, formatting, and presentation • Conduct literature searches as needed • Perform peer QC reviews as needed • Contribute to medical writing operational initiatives such as templates, style guides, and reference management

🎯 Requirements

• Experience (5+ years) 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 desired in writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents • 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 the requirements for preparation of key clinical and regulatory documents, including ICH and US regulatory requirements; working knowledge of ex-US regulatory requirements is 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 both independently and collaboratively in the face of 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 • Must be based in Germany and legally authorised to work there

🏖️ 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