Senior Medical Writer

Job not on LinkedIn

🔥 15 hours ago

🇿🇦 South Africa – Remote

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 10%

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

💰 $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 • Partner cross-functionally with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management 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 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 • 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 messaging, formatting, and presentation • Conduct literature searches as needed • Perform peer quality-control review 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 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 • South Africa-based applicants must be legally authorized to work in South Africa

🏖️ 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