Principal / Associate Principal Medical Writer

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September 26

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Trilogy

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SaaS • Enterprise • B2B

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.

201 - 500 employees

Founded 1989

☁️ SaaS

🏢 Enterprise

🤝 B2B

📋 Description

• Function as a lead writer to prepare a variety of clinical regulatory documents (Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications) in collaboration with members of client authoring teams and supported by other writers, as appropriate • Ensure that all documents are produced according to agreed timelines, monitor and manage project budgets, adhere to relevant SOPs, and meet the requirements of Trilogy as well as the company’s clients • Provide document-specific advice to clients • Oversee and coordinate other writers and QC specialists assisting with documents under your responsibility • Project manage the timelines and review cycles of your documents • Work in the client’s regulatory document management systems

🎯 Requirements

• At least 5 years of experience of actively writing regulatory documents • Experience as a lead writer on CTD documents is mandatory • Must have worked as the lead writer on Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications • Experience as the lead writer with multiple-document projects with global, multinational teams, including team management, project management, review management, and budget oversight • Must be able to manage multiple projects simultaneously • In-depth working knowledge of relevant regulatory guidance (e.g. ICH, FDA, EMA) for clinical trial conduct, including document-specific guidance • Experience in multiple therapeutic areas • Advanced understanding of and ability to apply statistical, regulatory, and medical communication concepts to independently write complex regulatory documents without supervision • Competency in the use of document management systems and review tools • Minimum of a Bachelor's degree in science/pharmacy (Ph.D. not necessary) • Fluent written and spoken English skills • An appreciation for a well-written document and an eye for detail • Excellent, proven interpersonal skills and enjoy proactively participating on a team with diverse personalities • Flexibility and the 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