- Location
- Mumbai, IN
- Type
- Full-time
- Department
- Management
- Seniority
- Lead
- Experience
- 20+ years
- Closing date
- Today
- Source
- iCIMS
Description
Job Purpose
Job Purpose
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.
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.
About Transform
At RWS, we enable the world’s largest enterprises to communicate with global audiences through cutting-edge language technology, AI-driven solutions, and expert services. Our RWS Transform division empowers organizations to accelerate digital transformation, scale global content, and unlock growth in every market.
Job Overview
Key Responsibilities
- 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 Understand 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 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
- Bachelor’s degree in business, English, Foreign Language, Social or Applied Science, or another related field.
- Fluency in a non-English language preferred.
- Translation experience preferred.
- 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.