Job Summary
The Associate II, TMF Operations role involves the processing and maintenance of essential documents in compliance with relevant regulations and industry best practices. The successful candidate will be responsible for ensuring the management of these documents, supporting the delivery of department objectives, and working collaboratively with a global project team.
* Process and review rejected Trial Master File (TMF) documents in electronic and hard copy formats.
* Perform periodic quality control checks to ensure adherence to regulatory, ICH GCP, and industry standards.
* Work with various electronic document management systems to review, classify, and process essential documents.
* Communicate with the RMC Lead to report trends and issues related to the TMF.
* Evaluate and escalate any TMF quality issues in a timely manner.
* Provide administrative support to the RMC Lead, including filing and maintaining internal documents on SharePoint.
About You
* Demonstrate proficiency in electronic document repositories and document recognition skills.
* Show strong interpersonal skills in a fast-paced environment.
* Exercise sound judgment to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel is required.
Your Qualifications
* University Degree preferred, Life Science desirable.
* 1-2 years of relevant experience.
* Familiarity with highly regulated industries is an asset.
Benefits
This role offers opportunities for professional growth and development in a dynamic work environment. The successful candidate will be part of a collaborative team that values innovation and excellence.