Job Summary
The Associate II, TMF Operations role involves the processing and maintenance of essential documents in compliance with regulatory requirements.
This position requires strong organizational skills and attention to detail to ensure accurate documentation and efficient workflow management.
The ideal candidate will have proficiency in electronic document management systems and excellent communication skills to collaborate effectively with a global team.
* Key Responsibilities:
* Process and review trial master file (TMF) documents for complex studies or sponsor portfolios.
* Perform periodic quality control checks to ensure adherence to regulatory and industry standards.
* Collaborate with project teams to resolve document issues and maintain accuracy.
* Provide administrative support to the RMC Lead, including filing and maintaining internal documents.
About You
* Requirements:
* A university degree is preferred, with a life science background desirable.
* 1-2 years of relevant experience in a highly regulated industry.
* Proficiency in Microsoft Office applications, particularly Word and Excel.
* Strong interpersonal skills and ability to work in a fast-paced environment.
Your Experience Matters
* Preferred Qualifications:
* Experience working within a highly regulated industry, such as pharmaceuticals or medical devices.
* Knowledge of electronic document management systems and eTMF tools.
We Offer
* Benefits:
* A dynamic and supportive work environment.
* Ongoing training and development opportunities.
* A competitive salary and benefits package.