Principal/Associate Principal Medical Writer

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Trilogy

WebsiteLinkedInAll Job Openings

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

• Function as a lead writer to prepare clinical regulatory documents, including Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, and scientific publications • Collaborate with client authoring teams and other writers • Ensure documents are produced according to agreed timelines, monitor and manage project budgets, adhere to relevant SOPs, and meet Trilogy and client requirements • Provide document-specific advice to clients • Oversee and coordinate writers and QC specialists assisting with assigned documents • Project manage document timelines and review cycles • Work in clients’ regulatory document management systems

🎯 Requirements

• At least 5 years of experience actively writing regulatory documents • Experience as a lead writer on CTD documents is mandatory • Lead-writer experience on Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, and scientific publications • Experience leading multiple-document projects with global, multinational teams, including team management, project management, review management, and budget oversight • Ability to manage multiple projects simultaneously • In-depth working knowledge of relevant regulatory guidance, including ICH, FDA, and EMA guidance for clinical trial conduct • Experience in multiple therapeutic areas • Advanced understanding of statistical, regulatory, and medical communication concepts • Competency using document management systems and review tools • Minimum of a 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

🏖️ Benefits

• Competitive base salary • Annual bonus opportunity • A generous allowance of paid time off • Comprehensive benefit plans aligned with your region • Full EMWA membership and annual conference attendance paid for by Trilogy • Continuous personal and professional development opportunities • Free weekly yoga sessions • Other fun and exciting events that encourage team bonding and development