Trilogy
201 - 500 employees
Founded 1989
🚘 Automotive
🛡️ Insurance
📦 Logistics
Automotive • Insurance • Logistics
Trilogy is a comprehensive business platform that helps software companies become more efficient and profitable by streamlining business functions such as development, product management, and R&D. Founded by Stanford dropouts in Silicon Valley in 1989, Trilogy relocated to Austin, Texas in the early 90s and significantly contributed to the city’s transformation into a tech hub. Trilogy focuses on providing high-quality software and unmatched business efficiency managed by the top 1% of global tech talent. The platform offers end-to-end solutions including engineering, customer support, technical product management, finance & accounting, innovation R&D, SaaS operations, renewals, inside sales, and recruiting. By leveraging insights and continuous improvements, Trilogy enables exponential business growth and seamless operations for software companies around the world.
Principal Medical Writer
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Trilogy
201 - 500 employees
Founded 1989
🚘 Automotive
🛡️ Insurance
📦 Logistics
Automotive • Insurance • Logistics
Trilogy is a comprehensive business platform that helps software companies become more efficient and profitable by streamlining business functions such as development, product management, and R&D. Founded by Stanford dropouts in Silicon Valley in 1989, Trilogy relocated to Austin, Texas in the early 90s and significantly contributed to the city’s transformation into a tech hub. Trilogy focuses on providing high-quality software and unmatched business efficiency managed by the top 1% of global tech talent. The platform offers end-to-end solutions including engineering, customer support, technical product management, finance & accounting, innovation R&D, SaaS operations, renewals, inside sales, and recruiting. By leveraging insights and continuous improvements, Trilogy enables exponential business growth and seamless operations for software companies around the world.
📋 Description
• Prepare a variety of clinical regulatory documents as the lead writer in collaboration with client authoring teams and other writers • Ensure documents meet agreed timelines, project budgets, relevant SOPs, Trilogy requirements, and client requirements • Provide document-specific advice to clients • Oversee and coordinate other writers and QC specialists • Project manage document timelines and review cycles • Work in clients’ regulatory document management systems
🎯 Requirements
• Relevant professional experience actively writing regulatory documents • Lead writer on more than 5 documents in at least 3 specified document types, including clinical study protocols, clinical study reports, CTD clinical summaries, investigator brochures, IMPDs/INDs, scientific publications, PSUR/DSUR, PBRER, RMP, or PIP • Experience in at least 2 different types of CTD dossiers • Experience interacting directly with clients or document authors • Experience coordinating review cycles, meetings, and project timelines • Ability and willingness to take on projects requiring a Lead Writer • Competency with document management systems and review tools • Diploma, Master's, or Bachelor's degree in science or pharmacy; Ph.D. not necessary • Fluent written and spoken English • Appreciation for well-written documents and strong attention to detail • Excellent, proven interpersonal skills • Flexibility and ability to stay focused under tight timelines • Must live in Germany, Portugal, Italy, or Ireland • Freelancers need not apply • Submission of an English cover letter explaining compliance with the experience requirements and a CV
🏖️ Benefits
• Standard Trilogy benefits • Supportive environment in which everyone can grow, flourish, and do their best work • Fully remote work option • Office-based or hybrid work option
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