To be responsible for the coordination, execution, control and completion of single service projects ensuring consistency with ICON SOPs, service-line best practices, project contracts and budgets
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are seeking an experienced (Senior) Translation Project Manager to lead the planning, coordination, and delivery of clinical document translations in a highly regulated global environment. This role will partner closely with Medical Writing teams, business stakeholders, and translation service providers to ensure high-quality, compliant, and timely translations while driving innovation through AI-enabled translation technologies.
What You Will Do:
- The Senior Translation Project Manager (TPM) 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, other requestors of clinical document translations, 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.
Your Profile:
You will have solid project and programme management experience, with the ability to manage competing priorities and develop your team.
Required qualifications and experience:
Minimum 3 years of hands-on experience in clinical/regulatory document translation and/or bilingual quality control (QC), along with at least 2 years of translation project management experience within a complex, highly regulated, and multicultural environment. Experience should include 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 platforms designed to streamline workflows.
Working knowledge of AI and machine learning applications in translation technologies, including the ability to assess output quality and associated risks, establish appropriate expectations, and contribute to continuous process improvement.
Ability to develop and implement post-editing strategies aligned with document risk classifications, regulatory requirements, and intended use.
Excellent communication and interpersonal skills, with the ability to collaborate effectively across global teams and external business partners.
Demonstrates a growth mindset by challenging conventional approaches and encouraging innovative practices to drive continuous improvement.
Ability to work independently while also thriving in diverse, cross-functional, and multicultural team environments.
Open to feedback and committed to continuous learning and process enhancement.
Strong cross-cultural awareness and sensitivity, enabling effective collaboration across regions and cultures.
Proven ability to mentor colleagues, share knowledge, and contribute to the development of translation and project management expertise within the organization.
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
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