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.

Key Responsibilities

• Understands and adheres to company Quality Management System (QMS) requirements including but not limited to ISO 9001 and ISO 17100 standards.
• Reconciles and edits harmonized and back translations in a timely, efficient and accurate manner.
• Serves as Lead Project Manager on projects with multiple Project Managers.
• Coordinates and communicates with interviewers and recruiters for the purpose of conducting debriefing interviews, analyzing results, and making recommendations for improvements.
• Coordinates and communicates with translators, research specialists, in-country/client reviewers, and others as needed.
• Provides assistance and training to Associate Project Managers during projects at the direction of department Supervisor or Manager.
• Coordinates with colleagues in other departments for the purpose of ensuring efficient workflow.
• Maintains accurate and up-to-date spreadsheets and other documents needed to ensure that that there is a complete overview of the current status of LV projects and that information is readily retrievable.

• Assists in maintaining and ensuring the reliability of key operating data and databases.
• Maintains project and client records as needed.
• Makes sure that clients are kept regularly informed as to the status of projects and otherwise communicates with clients as needed to ensure client needs are met and issues are resolved.

• Composes or generates a variety of materials (e.g. reports, memos, letters, manuals, etc.) for the purpose of documenting activities, training, providing written reference and/or conveying information regarding the status of projects, etc.
• Ensures that projects are delivered to clients error-free and as specified within established timeframes.
• Recommends policies, procedures and/or actions for the purpose of improving efficiency and providing direction for meeting the company0s objectives. May implement and evaluate effectiveness of improvement initiatives.
• Performs other related duties, as assigned.
• May perform traditional project management functions as needed.

Skills & Experience

• Bachelor0s Degree in Business, English, Foreign Language, Social or Applied Science, or other related field.
• Successful experience in LV Project Management generally a minimum of three years.
• Previous experience in the translation industry preferred.

• Knowledge of all company LV project management, graphic layout, and project planning procedures.
• Knowledge of English grammar, syntax, and word usage, and excellent proofreading skills.
• Organizational and time management skills.
• Ability to report work orally or in writing to supervisor as required.
• Ability to carry out instructions furnished in written or oral form, and to work with minimal supervision.
• Ability to understand, apply and use personal computers and software applications (e.g., Word, Excel, PowerPoint, Adobe, CAT Tools, Office 365/Skype).
• Ability to work with a diverse group of individuals.
• Ability to maintain confidentiality of information regarding company financial and other information.
• Ability to establish and maintain cooperative working relationships with others contacted in the course of work; teamwork and consensus-building skills.
• Ability to resolve customer service issues in a professional and efficient manner.

Benefits

• Possibility to do charity work for 5 days paid.
• 4 weeks0holiday, your birthday OFF and 5 sick days.
• Access to a vast library of eLearning training.
• Great benefits plan (dental, medical, STD/LTD, EAP00)
• Hybrid/Remote model and Agile work practices

Location - CANADA - EST coverage required