Senior QC Specialist

Job not on LinkedIn

🕒 June 25

🌐 Germany, United Kingdom, +3 more countries – Remote

🇩🇪 Germany – Remote 🇬🇧 United Kingdom – Remote 🇵🇹 Portugal – Remote 🇮🇹 Italy – Remote 🇮🇪 Ireland – Remote

⏰ Full Time

🟠 Senior

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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 an independent QC Specialist on any QC project. • Check that all numbers used in text and tables and statements based on data are correct using the source tables, figures, or listings • Ensure the text is in line with the required style guide to ensure consistency in hyphenation, capitalization, formatting of references, Word styles, etc … • Check text to ensure it is well written, logically structured, and consistent with the supporting data • Check facts and raise queries with the author • Check tables/figures and captions are correct • Support other QC Specialists and/ or cover absences on any project • Support other medical writers in simple writing and other activities involved in the preparation of documents (e.g., creating a List of Abbreviations, populating tables with data or checking literature references) • For projects on which they are the Lead QC Specialist, monitor QC timelines • Attend meetings with clients, as needed, to coordinate and proactively manage client QC activities • Oversee and coach Associate QC Specialists • Be a Client QC Manager for a specific client

🎯 Requirements

• A minimum of 3 years’ /relevant experience as a QC Specialist in a clinical regulatory setting • A scientific qualification (BA, BSc, MA, MSc, PhD, or equivalent) • Fluent written and spoken English skills • Performed QC activities on at least 5 different key regulatory documents (e.g., CSR, CSP, Module 2.7 summary for CTD) • Proven ability to correctly identify scientific text (based on a QC test) • An appreciation for a well written document and an eye for detail • An appropriate skillset to proactively participate in a team with diverse personalities (i.e., good interpersonal skills) • Advanced knowledge of MS Office software (i.e., Word and Excel) and Adobe • Ability to handle all stages of the QC process on complex documents • Managing all interactions with Lead Writers without the support of another QC Specialist • Oversight and coordination of other QC Specialists who are supporting them as the Lead QC Specialist on a complex QC project • Understanding when to request support from other QC Specialists to meet deadlines, if required • A positive attitude and an ability to work under pressure, find pragmatic solutions to problems, and maintain oversight of QC activities across a complex project.

🏖️ Benefits

• Competitive base salary (dependent on experience level and the company’s compensation practices) • Annual bonus based on company and individual performance. • A generous allowance of paid time off (vacation, holiday, birthday, illness). • Additional country-specific benefits • Free weekly yoga sessions • Other fun and exciting events to encourage team bonding and development.