**Job Overview**
This role focuses on ensuring the integrity and quality of essential documents within a highly regulated industry. As an Associate II, you will be responsible for processing, maintaining, and archiving documents in compliance with relevant standards, regulations, and industry best practices.
The successful candidate will support the delivery of department objectives by ensuring the effective management of essential documents. This is a global role requiring collaboration with project team members worldwide.
Main Responsibilities
* Process, review, and resolve rejected Trial Master File (TMF) documents, both in electronic and hard copy formats, for complex studies or Sponsor portfolios.
* Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
* Work with various Electronic Document Management 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.
* Provide administrative support for the RMC Lead, including filing and maintaining internal documents on SharePoint.
Key Skills and Qualifications
* Proficiency in using electronic document repositories or eTMFs, 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.
Requirements
* University Degree preferred, with Life Science being desirable.
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry is a plus.