Job Summary
The Associate II, TMF Operations is a key role in the processing, maintaining, and archiving of essential documents. The position requires adherence to regulatory standards, ALCOA principles, country regulations, and industry best practices.
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Responsibilities:
* Process and review rejected Trial Master File (TMF) documents in electronic and hard copy formats.
* Perform periodic TMF Quality Control to ensure compliance with regulatory requirements.
* Work with Electronic Document Management and eTMF Systems to review, classify, and process Essential Documents.
* Communicate with RMC Lead on trends and issues related to the TMF.
* Evaluate and escalate TMF Quality issues in a timely manner.
* Provide administrative support for the RMC Lead, including filing and maintaining internal documents.
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Requirements:
* Proficiency in using an electronic document repository or eTMF, along with document recognition skills.
* Strong interpersonal skills in a fast-paced environment.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
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Preferred Qualifications:
* University Degree, preferably in Life Sciences.
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry.
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