Senior Translation Project Manager

About the Role

The Senior Translation Project Manager will lead planning, coordination and delivery of clinical document translations in a highly regulated global environment. You will partner with Medical Writing teams, stakeholders, and translation service providers to ensure high-quality, compliant and timely translations while driving innovation through AI-enabled translation technologies. What You'll Do

• Serve as the lead for clinical document translations, ensuring high-quality and timely delivery.

• Streamline the translation process to achieve consistent quality, faster delivery, and cost-effectiveness.

• Collaborate with stakeholders to enhance processes and manage translation vendors for optimal performance.

• Cultivate strong relationships with stakeholders and stay abreast of industry trends to drive continuous improvement.

• Lead and coordinate clinical document translations in-line with Takeda standards, ensuring adherence to regulatory guidelines and priorities, with a primary focus on documents delivered from medical writing.

• Act as the point of contact between internal/external stakeholders, including medical writers and translation service providers.

• Coordinate the planning, collection, and follow-up of translation requirements in close collaboration with all stakeholders, ensuring effective communication and seamless translation processes from planning to closing.

• Ensure compliance with translation deadlines, budget constraints, and quality controls based on company/regulatory norms.

• Provide project management support and expertise to Takeda clinical teams in translation, including gathering requirements, planning resources and budget, coordinating translation tasks, and ensuring quality control.

• Contribute to the implementation and improvement of Takeda's translation tools, including the implementation and management of Takeda's AI enabled translation platform, ensuring it meets the needs of clinical document translation.

• Collaborate with IT and other departments to thoroughly analyze and assess deliverables from the AI translation platform, ensuring exceptional quality and high accuracy of translations, and provide constructive feedback to enhance the AI platform capabilities.

• Collaborate with AI developers and IT teams to optimize translation algorithms and improve overall platform efficiency.

• Coordinate Subject Matter Expert (SME) review of post-AI translated documents within the AI translation platform to ensure translations meet required quality standards and incorporate expert input. Address and reconcile SME feedback thoroughly, finalize the translation, and confirm the document is accurate and ready for formatting and downstream activities. What We're Looking For

• Solid project and programme management experience, with the ability to manage competing priorities and develop your team.

• Minimum 3 years of hands-on experience in clinical/regulatory document translation and/or bilingual quality control, along with at least 2 years of translation project management experience within a complex, highly regulated, and multicultural environment.

• Experience managing translation vendors, utilizing translation tools and technologies, and effectively planning, allocating, and monitoring translation activities to ensure adherence to timelines and quality standards.

• Strong familiarity with clinical and regulatory document types, including Protocols, Investigator's Brochures (IB), Clinical Study Reports (CSR), and CTD Module 2 Clinical Summaries and Overviews, with demonstrated expertise in maintaining terminology consistency across documents and versions.

• Proven project management capabilities, including end-to-end project planning, scheduling, scope and change management, risk mitigation, and vendor oversight.

• Strong understanding of data protection, compliance, and controlled document management practices, including secure external sharing, audit trail maintenance, traceability, and document governance requirements.

• Experience in budget planning and financial management is highly desirable.

• Demonstrated ability to embrace innovation and leverage emerging technologies, networks, and tools to enhance translation project efficiency and outcomes.

• Strong analytical and problem-solving skills, with the ability to develop creative solutions while maintaining the highest standards of quality, compliance, and professional integrity.

• Exceptional organizational and time-management skills, with the ability to manage multiple concurrent translation projects while maintaining accuracy and attention to detail.

• Proven ability to perform effectively in fast-paced, deadline-driven environments, demonstrating resilience, confidence, and a high degree of independence.

• Unwavering commitment to professional ethics, integrity, and confidentiality.

• Business-level proficiency in Mandarin (spoken), Simplified Chinese (written), and English (spoken and written).

• Advanced proficiency in Microsoft Office applications (Word, Excel, and PowerPoint), including expert-level Word formatting skills such as styles, templates, Track Changes, cross-referencing, automated numbering, and document version comparison.

• Hands-on experience with Computer-Assisted Translation (CAT) tools, QA tools, translation memory (TM) and terminology database (TB) import/export processes, as well as AI-enabled translation. Nice to Have

• Budget planning and financial management is highly desirable.