Regulatory Operations Assistant

Job Responsibilities and Skills:

• Disclosures work is performed under the close supervision of more senior staff following detailed instructions with well-defined procedures.
• Registration of new Clinical Trials on CTgov
• Regular updates to Protocol Records on CTgov
• Results Posting for Clinical Trials on CTgov and EudraCT
• Policy 0070 work is performed under the close supervision of more senior staff following detailed instructions with well-defined procedures.
• Collection, e-organization/e-filing, and tracking of Policy 0070 required documents
• Extraction and preparation of Policy 0070 required documents
• Draft Auto-Redaction and Manual Redaction of Policy 0070 documents
• Facilitation of Policy 0070 review process
• Finalization and publication of Redacted documents
• Preparation of other Policy 0070 materials (e.g. CCI Justification Tables, Anonymization Report, Cover Letter, Document Inventory, etc.)
• Performs QC/editing reviews of documents such as CSRs, IBs, CTDs, and other Clinical or Regulatory documents in line with Client internal document standards.
• Has strong organization skills and attention to detail, along with ability to work on a number of projects with tight timelines is required.
• Attends and participates in routine group meetings. May attend cross-functional meetings under the direction of a more senior staff meeting.
• Has excellent verbal and written communication skills and interpersonal skills.
• Has well developed computer skills including proficiency in Word, Adobe and Excel.