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Advanced Recruiting Partners · 1 week ago

Administrative Assistant - Pharma

Raleigh, NC

Part-time

Onsite

Entry Level

2+ years exp

Advanced Recruiting Partners is seeking an Administrative Assistant in the pharmaceutical sector. The role involves maintaining and archiving records, performing data entry for regulatory projects, and supporting the finalization of job descriptions and standard operating procedures.

Human ResourcesRecruitingStaffing Agency

Responsibilities

Maintain and archive both paper and electronic records in accordance with internal procedures to ensure complete and compliant regulatory files for each product

Perform data entry for regulatory projects, including work within Regulatory Information Management Systems (e.g., Veeva), Microsoft Office applications (Excel, Word), and Smartsheet

Support the finalization of job descriptions and standard operating procedures (SOPs), including routing for review, approval, signature, and appropriate filing

Prepare, submit, and archive FDA promotional and labeling submissions

Serve as the U.S. R&D Archivist, overseeing document management activities

Maintain the U.S. on-site document storage room

Manage the U.S. off-site storage vendor and track documents sent and received

Annually archive and transition off-site files older than five years

Support unblinded safety submissions, including DSURs, as needed

Provide support during audit preparation when required

Assist in the preparation of U.S. regulatory deliverables

Perform quality control reviews of U.S. regulatory submissions and internal documents

Qualification

Pharmaceutical regulationsRegulatory processesProcess analysis toolsMicrosoft OfficePlanningExecutionCommunicationAttention to detailTime managementDecision-making