Senior QC Specialist

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🕒 il y a 1 mois

🌐 Allemagne, Royaume-Uni, +3 autres pays – Distant

🇩🇪 Allemagne – Télétravail 🇬🇧 Royaume-Uni – Télétravail 🇵🇹 Portugal – Télétravail 🇮🇹 Italie – Télétravail 🇮🇪 Irlande – Télétravail

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🟠 Senior

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Trilogy

Site WebLinkedInTous les Emplois

201 - 500 employés

Fondée en 1989

🚘 Automobile

🛡️ Assurance

📦 Logistique

Automotive • Insurance • Logistics

Trilogy est une plateforme commerciale complète qui aide les entreprises de logiciels à devenir plus efficaces et rentables en rationalisant des fonctions professionnelles telles que le développement, la gestion de produits et la R&D. Fondée par des étudiants ayant quitté Stanford dans la Silicon Valley en 1989, Trilogy a déménagé à Austin, Texas, au début des années 90 et a contribué de manière significative à la transformation de la ville en un centre technologique. Trilogy se concentre sur la fourniture de logiciels de haute qualité et d'une efficacité commerciale inégalée, gérée par le top 1% des talents technologiques mondiaux. La plateforme offre des solutions de bout en bout incluant l'ingénierie, le support client, la gestion technique des produits, la finance et la comptabilité, l'innovation R&D, les opérations SaaS, les renouvellements, la vente interne et le recrutement. En s'appuyant sur des insights et des améliorations continues, Trilogy permet une croissance exponentielle des affaires et des opérations sans faille pour les entreprises de logiciels à travers le monde.

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

🎯 Exigences

• 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.

🏖️ Avantages

• 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.