As a Key Document Specialist, you will be responsible for ensuring the accuracy and completeness of essential documents in compliance with regulatory requirements.
This role involves processing, reviewing, and resolving rejected documents, as well as performing periodic quality control checks to ensure adherence to industry best practices.
You will work closely with the RMC Lead to report trends and issues related to document management, and escalate any quality issues in a timely manner.
* Process and review electronic and hard copy documents in both complex study and Sponsor portfolio environments.
* Utilize Electronic Document Management and eTMF systems to review, classify, and process essential documents.
* Communicate effectively with stakeholders to address document-related issues and concerns.
Key Requirements:
* Strong understanding of document management principles and regulations.
* Excellent interpersonal and communication skills.
* Ability to work accurately and efficiently in a fast-paced environment.
Your Background:
* University degree preferred (Life Science desirable).
* 1-2 years of relevant experience in a highly regulated industry.
* Proficiency in Microsoft Word and Excel.