EMEA RMC Translation Management Specialist; M​/K

Overview

Employer:

Manpower Group Solutions Sp. z o.o. Along with Manpower Group Solutions, we are seeking a candidate for the position of Regulatory Translation Management Specialist (M/K) located in Poland to support the global processes of our client. We are offering cooperation with one of the biggest pharmaceuticals concerns in Poland.

The Regulatory Translation Management Specialist (M/K) will be part of our client's global ERMC team, responsible for overseeing translation quality control from external vendors and liaising with the European Medicines Agency (EMA).

• Coordinate translation activities of English source texts, such as EU Product Information (EUPI), in collaboration with external vendors, ERMC team, and local operating companies
• Ensure the accuracy and compliance of translated Product Information Annexes of Marketing Authorization against reference English documents, adhering to EU, reference country, and local legislation
• Perform or coordinate Quality Checks (QC) of local Product Information in cooperation with external vendors and local teams
• Maintain the compliance of local translated Product Information within the company’s validated repository system
• Establish effective communication with other ERMC sub-teams and stakeholders to facilitate seamless translation processes

• Bachelor’s degree or higher in a technical or related discipline
• Fluent in written and spoken English, with proficiency in at least one European language such as French or German, considered a great advantage
• Knowledge of EMA (European Medicines Agency) procedures and EU Centralized Procedure (EUCP)
• 1-3 years of experience in a regulated industry, preferably pharmaceuticals or healthcare
• Previous experience in documentation review for translation management
• Strong interpersonal and collaborative skills to work effectively across teams
• Ability to implement Standard Operating Procedures (SOPs) and follow compliance-driven processes
• Excellent communication, organizational, and time management skills
• Proficiency in MS Office Suite, including Outlook, Word, Excel, and Power Point
• Strong remote working skills, including internet usage, online communication tools such as Zoom or Teams, and online process coordination

• Competitive salary package aligned with industry standards
• Comprehensive health benefits including life insurance and wellness programs
• Company-sponsored Sport Card promoting a healthy lifestyle
• Opportunities for professional development and career growth within a global organization
• Supportive and inclusive work environment fostering innovation and collaboration

Take the next step in your career by applying now and becoming a vital part of this innovative healthcare organization. Join a team dedicated to making a difference in patients' lives while enjoying excellent benefits and a dynamic work atmosphere.

Manpower (Agencja zatrudnienia ) to globalna firma o ponad 70-letnim doświadczeniu, działająca w 82 krajach. Na polskim rynku jesteśmy od 2001 roku i obecnie posiadamy prawie 35 oddziałów w całym kraju. Naszym celem jest otwieranie przed kandydatami nowych możliwości, pomoc w znalezieniu pracy odpowiadającej ich kwalifikacjom i doświadczeniu. Skontaktuj się z nami - to nic nie kosztuje, możesz za to zyskać profesjonalne doradztwo i wymarzoną pracę!