Senior/Principal Medical Writer

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🕒 May 14

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Trilogy

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 1989

☁️ SaaS

🏢 Enterprise

🤝 B2B

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.

📋 Description

• 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) as the lead writer 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 • Be responsible for providing document-specific advice to clients • Oversee and coordinate other writers and QC specialists assisting on documents under your responsibility • Project manage the timelines and review cycles of your documents • Work in the client’s regulatory document management systems

🎯 Requirements

• Several years of professional experience actively writing regulatory documents • Worked as the lead writer on >3 (Senior Medical Writer) or >5 (Principal Medical Writer) of at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications • For the Principal Medical Writer level, experience in at least 2 different types of CTD dossiers (i.e. full new chemical entity application, a variation, a generic dossier, an orphan drug dossier, a literature-based dossier [e.g. a full-mixed application under Article 8(3) of Directive 2001/83/EC]) • Experience interacting directly with clients or authors of the documents and coordinating review cycles, meetings, and project timelines • For the Principal Medical Writer level, ability and willingness to take on any project for which a Lead Writer is needed • Competency in the use of document management systems and review tools • Diploma/Masters/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 details • Excellent, proven interpersonal skills and enjoy proactively participating on a team with diverse personalities • Flexibility and the ability to stay focused under tight timelines • Must live in the UK, Germany, Italy, Ireland, or Portugal.

🏖️ Benefits

• standard Trilogy benefits