About the Role
The Associate II, TMF Operations is a critical position responsible for ensuring the management of essential documents in compliance with relevant regulations and industry best practices. This role requires strong organizational skills, attention to detail, and effective communication.
Key Responsibilities
* Process and review Trial Master File (TMF) documents, resolving rejected documents and maintaining accurate records.
* Perform regular quality control checks to ensure adherence to regulatory requirements and industry standards.
* Utilize electronic document management systems to classify, process, and maintain essential documents.
* Communicate effectively with the RMC Lead to report trends and issues related to the TMF.
* Escalate any quality issues in a timely manner to ensure prompt resolution.
Requirements
* Proficiency in using electronic document repositories and document recognition skills.
* Strong interpersonal skills for effective collaboration in a fast-paced environment.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
Education and Experience
* University degree preferred, with a focus on life sciences desirable.
* 1-2 years of relevant experience, preferably in a highly regulated industry.