Main Purpose of Role
This role involves working independently with limited supervision, applying subject matter expertise to meet specific needs or requirements.
The ideal candidate will have the capacity to understand and apply skills/knowledge in a controlled documentation system, record retention, and information services, including electronic records retention processes, in accordance with regulatory requirements.
Main Responsibilities
•Ensuring compliance with regulatory agencies' requirements and maintaining technical and non-technical documentation change systems.
•Classifying and maintaining records, ensuring procedures are in place to adhere to regulatory standards.
•Interpreting and enforcing documentation formatting, standards, policies, and operating procedure requirements.
•Identifying submission components, communicating documentation standards, and coordinating assembly of regulatory dossiers.
•Analyzing and evaluating data, extracting pertinent information, preparing information abstracts, and executive summaries of material searched.
Qualifications
A minimum of an Associate's Degree (± 13 years) and at least 1 year of experience/background in a related field is required.
Estimated Salary: $45,000 - $65,000 per annum, depending on location and experience.
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