PV RA MW Coordinator

2 weeks ago


India Thermo Fisher Scientific Full time


• Provides critical support and coordination in the review of safety and regulatory publishing documents, ensuring timely and accurate processing upon receipt.


• Plays a key role in maintaining document quality by tracking safety and regulatory publishing data, ensuring seamless uploading into internal and/or external electronic trial master files.


• Takes responsibility for maintaining the confidentiality and integrity of sensitive information, meticulously ensuring the redaction of Commercially Confident Information and Personal Data for regulatory publishing.


• Assists in the maintenance of licenses across projects, ensuring compliance with IT Security standards and facilitating smooth operations for users.


• Takes charge of coordinating and facilitating project meetings, ensuring effective communication and collaboration among team members.


• Demonstrates exceptional organizational skills by managing project-specific training, setting up and maintaining program files, and ensuring audit readiness.


• Protects subject and client confidentiality by identifying and redacting confidential identifiers according to local requirements, providing necessary retraining, and escalating any recurring issues to PPD Data Privacy.


• Performs accurate and efficient data entry into various databases and tracking systems, including PPD's budget management system, ensuring project timelines are not compromised.


• Takes ownership of overseeing expenses and managing translations, ensuring adherence to budget parameters and cost-efficiency.


• Assists in the essential task of archiving regulatory publishing documents and submissions, contributing to the seamless flow of information and compliance.


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