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1 day ago
Job Title: Regulatory Operations Specialist
Key Responsibilities:- Coordinate administrative tasks to support the regulatory translation hub's functioning.
- Manage access to relevant team members and keep access information updated.
- Organize and archive documentation in team repositories, including dispatch emails and surveys as required.
- Ensure timely renewal of licenses for translation-related software and indexing tools.
- Update team lists and trackers, e.g., general job list, invoicing tracker, QC tracker, quality incidents tracker, email contact lists, CO job list tracker.
- Assist team members with report and presentation preparation.
Financial Transactions Management
- Manage invoices and create purchase orders on behalf of the Head of Regulatory Translations.
- Maintain accurate invoice records.
- Address invoicing-related matters with vendors or service providers.
Operational Support
- In the absence of Regulatory Translations project managers or at their request, assign urgent jobs to appropriate vendors and perform quick format checks on outsourced translations before delivery.
- Provide support with uploading and downloading files from relevant databases as necessary.
- Certified Administrative Professional (CAP) certification or an equivalent administrative degree.
- Fluency in English (both written and spoken). Proficiency in other languages (optional)
- At least 3 years of administrative experience, especially in Regulatory Affairs.
- Strong problem-solving skills.
- Proficiency in Office tools (Excel a must).
- Excellent organizational skills.
- Adaptability.
- Commitment to quality.
- Good interpersonal skills.
- Highly committed and team-oriented.
- Clinical Study Reports, Data Analysis, Documentation Management, Lifesciences, Operational Excellence, Regulatory Compliance
Regulatory Compliance Specialist, Translation Operations, Regulatory Document Management, Clinical Research Coordinator
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