Role Summary
This position is responsible for the processing, maintaining and archiving of essential documents in compliance with regulatory requirements.
Key Responsibilities
* Process and review rejected Trial Master File (TMF) documents in electronic and hard copy formats.
* Perform periodic TMF Quality Control to ensure adherence to regulatory and industry best practices.
* Work with various Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents.
* Communicate directly with the RMC Lead to report trends and issues relevant to the TMF.
* Escalate any TMF Quality issues in a timely manner to the RMC Lead.
Required Skills and Qualifications
* 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.
Your Experience
* University Degree preferred (Life Science desirable).
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry (desirable).
About This Role
This role offers the opportunity to work in a global environment, supporting the delivery of department objectives. The Associate will be responsible for managing essential documents, ensuring compliance with regulatory requirements.
This is an excellent opportunity for individuals with a strong background in document management and quality control, looking to take on new challenges in a dynamic environment.
The ideal candidate will possess excellent communication and interpersonal skills, with the ability to work effectively in a team environment.