TMF Compliance Specialist
4 days ago
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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