LV Quality Specialist

Under the supervision of an LV Quality & Purchasing Supervisor or the department Manager, the LV Quality Specialist performs internal quality tasks to create error-free, linguistically validated Clinical Outcome Assessments (COAs).

The role performs editing and proofreading of clinical study documents, reconciles discrepancies with internal and external resources as needed and ensures quality tasks are completed in a timely and thorough manner

About Linguistic Validation

Linguistic Validation (LV) is a specialized business unit within RWS Regulated Industries that focuses on the translation, validation, licensing, and electronic implementation of Clinical Outcome Assessments (COAs). COAs are questionnaires completed during clinical trials which allow sponsors to collect data about treatment effectiveness, side effects, and health status directly from patients and caregivers.

The LV Team is over 20 years of experience in the COA field, positioning us as the industry leader. Our team performs a wide variety of functions in addition to translation, including recruitment and interviewing of patients around the world, development of novel research for presentation and publication, expertise in licensing and copyrights, and management of electronic implementation of COAs (eCOA) in over 80 languages.

For more information, visit: RWS

Key Responsibilities

Understands and adheres to company Quality Management System (QMS) requirements.
• Fully comprehends project instructions, relays them appropriately and effectively to translators as well as assists them in resolving issues.
• Communicates with LV colleagues to ensure all quality tasks are completed as required to meet project specifications.
• Maintains up-to-date information in company records and databases, including the appropriate management of project documentation.
• Understands translator feedback systems and utilizes them as needed.
• Reviews and updates translations, including eCOA screen reports, in a timely, efficient and accurate manner.
• Purchases a limited number of services from qualified translators based upon availability, language, expertise, deadlines, cost and other relevant considerations.
• Accurately and efficiently processes feedback on translation work provided by third parties.
• Ensures that all assigned quality tasks are completed as specified within established timelines and that client deliverables are free from errors.
• Ensures supplementary quality materials needed for shipment are prepared accurately (e.g. certifications).
• Serves as back-up to other LV Quality Specialists during absences.

Skills & Experience

• Strong organizational skills in a fast-paced, deadline-driven environment
• Ability to prioritize and coordinate multiple projects and competing work demands
• Ability to consistently meet deadlines and maintain composure under pressure
• Ability to communicate effectively and to clearly understand project requirements
• Fluent in written and oral English with the ability to succinctly respond to queries in a timely manner
• Proficient computer skills
• Possess the skills to problem solve issues independently
• A team player who can collaborate effectively with a diverse group of individuals
• Ability to maintain confidentiality of company information
• Quality focused and detail oriented
• Excellent proofreading and visual comparison skills
• Good understanding of general linguistics
• Aptitude to work with non-standard file types (e.g. .xml files) and manage very basic formatting tags
• Expert level understanding of English grammar, syntax and semantics

At RWS, we're here for one purpose: unlocking global understanding.

As a unique, world-leading provider of technology-enabled language, content, and intellectual property services, we remove the barriers to communication to make global connection possible. Our unrivalled experience and deep understanding of language have been developed over more than 60 years. As we look to shape the future, our ambition is to create a world where understanding is universal for everyone.

We work with over 80% of the world's top 100 brands, more than three-quarters of Fortune's 20 'Most Admired Companies' and almost all the top pharmaceutical companies, investment banks, law firms and patent filers. Our client base spans Europe, Asia Pacific and North and South America. Our 65+ global locations across five continents service clients in the automotive, chemical, financial, legal, medical, pharmaceutical, technology and telecommunications sectors.

Over the past 20 years we've been evolving our own AI solutions as well as helping clients to explore, build and use multilingual AI applications. With 45+ AI-related patents and more than 100 peer-reviewed papers, we have the experience and expertise to support clients on their AI journey.

If you like the idea of working with smart people who are passionate about breaking down language barriers and giving back to their communities, then you'll love life at RWS. Our work fundamentally recognizes the value of every language and culture. So, we celebrate difference, we are inclusive and believe that diversity makes us strong.

We want every employee to grow as an individual and excel in their career. In return, we expect all our people to live by the values that unite us: to partner with colleagues and clients, to adopt a pioneering spirit, to be positive in progressing the work we do, and always to deliver what we promise.

RWS Values

Get the 3Ps right - Partner, Pioneer, Progress - and well Deliver together as One RWS.

For further information, please visit: RWS

RWS embraces DEI and promotes equal opportunity, we are an Equal Opportunity Employer and prohibit discrimination and harassment of any kind. RWS is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at RWS are based on business needs, job requirements and individual qualifications, without regard to race, religion, nationality, ethnicity, sex, age, disability, or sexual orientation. RWS will not tolerate discrimination based on any of these characteristics

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