Job Summary:
This role is responsible for the processing, maintenance, and archiving of essential documents in compliance with regulatory requirements and industry best practices. The successful candidate will work closely with a global team to ensure the delivery of department objectives.
Main Responsibilities:
The Associate II will perform various tasks including processing, reviewing, and resolving rejected Trial Master File (TMF) documents in both electronic and hard copy formats. This will involve working with multiple Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents.
Key Skills and Qualifications:
The ideal candidate will possess proficiency in using an electronic document repository or eTMF, as well as strong interpersonal skills and sound judgment. Proficiency in Microsoft Word and Excel is also required. Additionally, a university degree in a life science is preferred, along with 1-2 years of relevant experience in a highly regulated industry.
About the Role:
This is a dynamic and fast-paced environment that requires the ability to work independently and collaboratively as part of a global team. The successful candidate will be able to identify decisions requiring supervisory approval and communicate effectively with RMC Leads to report trends and issues relevant to the TMF.