Senior/Principal Medical Writer

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🔥 16 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

🏥📝 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

• Prepare clinical regulatory documents as lead writer, including Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in CTD format, Investigator Brochures, IMPDs/INDs, and scientific publications • Collaborate with client authoring teams and other writers • Produce documents according to agreed timelines 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 • Project manage document timelines and review cycles • Work in clients’ regulatory document management systems

🎯 Requirements

• Several years of professional experience actively writing regulatory documents • Lead writer on more than 3 projects at Senior Medical Writer level or more than 5 projects at Principal Medical Writer level, covering at least 3 specified document types • Principal level: 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 • Principal level: ability and willingness to take on any project requiring a Lead Writer • Competency in 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 and proactive team participation • Flexibility and ability to stay focused under tight timelines • Must be eligible to work in the UK • Freelancers need not apply • Submission of documents in English, including a 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