TMF Compliance Specialist

4 days ago


High Wycombe, Buckinghamshire, United Kingdom Johnson & Johnson Full time
Job Description

The Trial Master File (TMF) Analyst role at Johnson & Johnson Innovative Medicine involves ensuring the highest standards of quality and regulatory compliance in maintaining the TMF. This includes acting as a bridge between stakeholders, systems, and processes to drive process improvement and automation.

Main Responsibilities:

  • Enable stakeholder engagement and innovation by providing expertise, training, and automation solutions.
  • Design, develop, and implement TMF quality and oversight reports/metrics to ensure alignment with compliance standards.
  • Maintain system compliance and drive change management for process enhancements to support audits and inspections.
  • Provide centralized TMF filing and data support to optimize processes and ensure consistency.

Requirements:

  • At least 3 years of experience in the pharmaceutical industry or clinical trials.
  • Strong technical expertise, including proficiency in electronic records systems, IT tools, data warehouses, and database administration.
  • Familiarity with emerging technologies such as Robotic Process Automation (RPA), Machine Learning (ML), and Artificial Intelligence (AI).

Estimated Salary: $80,000 - $110,000 per year



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