About the Role
We are seeking an experienced Associate to join our team in a global role responsible for the processing, maintaining, and archiving of essential documents.
* Key responsibilities include reviewing and resolving rejected Trial Master File (TMF) documents, performing periodic TMF Quality Control, and working with electronic document management systems.
* The ideal candidate will have proficiency in using eTMF systems, strong interpersonal skills, and the ability to identify decisions requiring supervisory approval.
Your Key Responsibilities
1. Process and review TMF documents, ensuring adherence to regulatory requirements and industry best practices.
2. Perform quality control checks on TMF documentation to ensure accuracy and completeness.
3. Collaborate with project teams to resolve issues related to TMF documentation.
4. Provide administrative support to RMC Leads, including filing and maintaining internal documents.
Requirements and Qualifications
* A university degree in a life science is preferred, but not required. Relevant experience and knowledge of working within a regulated industry are highly desirable.
* Proficiency in Microsoft Word and Excel is essential.
* Strong communication and interpersonal skills are required to work effectively in a fast-paced environment.
About You
We are looking for a motivated and detail-oriented individual who can thrive in a dynamic environment.
In addition to your technical skills and qualifications, you should be able to:
* Work independently with minimal supervision.
* Maintain confidentiality and handle sensitive information.
* Communicate effectively with colleagues and stakeholders.