**Job Summary:**
We are seeking an experienced Associate II, TMF Operations professional to join our team. The ideal candidate will have a strong background in document processing and management.
* The Associate II, TMF Operations is responsible for the processing, maintaining, and archiving of all essential documents in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations, and industry best practices.
**Key Responsibilities:
* Process, review, and resolve rejected Trial Master File (TMF) documents, both in electronic and hard copy formats.
* Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
* Work with Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents.
* Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
* Elevate any TMF Quality issues in a timely manner to RMC Lead.
**Requirements:**
* Proficiency in use of an electronic document repository or eTMF, and document recognition skills.
* Strong interpersonal skills in a fast-paced, deadline-oriented environment.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
**Qualifications:**
* University Degree preferred (Life Science desirable).
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry (desirable).
Please note that this is a unique job opportunity for an experienced professional looking to grow their career in the field of TMF Operations.