The Associate II, TMF Operations role involves processing, maintaining and archiving essential documents in compliance with regulatory requirements.
This position supports the delivery of department objectives by ensuring the management of essential documents.
Responsibilities include:
* Reviewing and resolving rejected Trial Master File (TMF) documents
* Performing periodic TMF Quality Control to ensure adherence to regulatory standards
* Working with electronic document management systems to review and classify Essential Documents
Key skills required for this role include:
* Proficiency in using electronic document repositories or eTMFs
* Strong interpersonal skills in a fast-paced environment
* Sound judgment and decision-making abilities
Experience working in a highly regulated industry is desirable.
The ideal candidate will possess a university degree in a relevant field and 1-2 years of experience in a similar role.
Job Description Summary:
An exciting opportunity has arisen for an experienced professional to join our team as an Associate II, TMF Operations.
About the Role:
This role offers a challenging and rewarding career path for individuals who are passionate about working in a highly regulated industry.
Responsibilities:
Our ideal candidate will be responsible for:
* Processing and reviewing TMF documents to ensure accuracy and completeness
* Collaborating with internal stakeholders to resolve any issues or discrepancies
* Maintaining accurate records and documentation in accordance with regulatory standards
We offer a dynamic and supportive work environment, competitive salary and benefits package, and opportunities for professional growth and development.
What We're Looking For:
We are seeking a motivated and detail-oriented individual who possesses excellent communication and interpersonal skills.
A university degree in a relevant field and 1-2 years of experience in a similar role are preferred.
Experience working in a highly regulated industry is desirable but not mandatory.