Job Summary
The Associate II, TMF Operations is responsible for ensuring the management of essential documents in compliance with regulatory requirements. This global role requires working with project team members to achieve department objectives.
* Process and resolve rejected Trial Master File (TMF) documents in electronic and hard copy formats.
* Perform quality control to ensure adherence to regulatory, ICH GCP, and industry best practices.
* Review, classify, and process essential documents using electronic document management systems.
* Communicate with RMC Lead to report trends and issues relevant to the TMF.
* Evaluate and escalate any TMF quality issues to RMC Lead.
About the Role
This position supports the delivery of department objectives by ensuring the management of essential documents. The successful candidate will possess strong interpersonal skills, sound judgment, and decision-making abilities.
Responsibilities
* Document Management: Process, review, and resolve rejected TMF documents; perform quality control to ensure adherence to regulatory requirements.
* TMF Quality Control: Evaluate and escalate any TMF quality issues; communicate with RMC Lead to report trends and issues.
* Collaboration: Work with a variety of electronic document management systems; collaborate with project team members to achieve department objectives.
* Administrative Support: Provide administrative support for the RMC Lead, including filing and maintaining internal documents.
Requirements
To be successful in this role, you will need:
* A university degree preferred, preferably in Life Sciences.
* 1-2 years of relevant experience in a highly regulated industry.
* Proficiency in Microsoft Word and Excel.
Key Skills
The ideal candidate will possess:
* Strong interpersonal skills in a fast-paced environment.
* Sound judgment and decision-making abilities.
* Proficiency in electronic document management systems.
* Knowledge of regulatory requirements and industry best practices.
What You Will Bring
In addition to your technical skills and experience, we are looking for someone who can bring the following qualities to this role:
* A collaborative approach to working with project team members.
* A proactive attitude towards resolving quality issues.
* A commitment to delivering high-quality results under tight deadlines.
About Us
We are a dynamic organization committed to delivering high-quality results in a highly regulated industry. We offer a supportive work environment and opportunities for professional growth and development.