Senior Medical Writer

Job not on LinkedIn

🔥 1 hour ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 11%

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Logo of TGS

TGS

501 - 1000 employees

⚡ Energy

🤖 Artificial Intelligence

Energy • Artificial Intelligence • Digital

TGS is a leading energy data and services company formed through the merger of PGS and TGS. It specializes in providing high-quality seismic and well data to clients across the energy value chain, enabling strategic partnerships and informed decision-making. TGS also offers carbon storage and monitoring solutions, wind and solar energy operations, and advanced imaging and digital services powered by analytics and AI. With decades of geoscience expertise, TGS is committed to innovation, sustainability, and supporting energy exploration and production worldwide.

📋 Description

• Lead 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 according to client and agency guidelines • 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 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 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 • Must be based in Brazil and legally authorized 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

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