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Manager, Medical Affairs Operations Compliance Associate

San Mateo, CA 94404

Posted: 01/09/2023 Employment Type: Contract Job Category: Medical Affairs Job Number: 533680 Is job remote?: No Country: United States

Job Description

Job Title: 
Pay Rate Range: $41-51/hr
  • Provide guidance and oversight related to health authority (FDA, EMA, MHRA, etc.) regulations that impact the Medical Affairs organization.
  • Must have a very good attention to detail and demonstrate the ability to consistently meet the high standards required in Compliance deliverables.
  • Ability to consistently discern area(s) requiring input from Compliance, Quality and Pharmacovigilance business partners.
  • May assist in development or review of Medical Affairs SOPs and other procedural documents.
  • Participates in developing and presenting training using standard modules and training on compliance related topics.
  • Participates in the periodic assessment and review of Medical Affairs GxP role-based training plans to suggest improvements to existing curriculums.
  • Assists in audit readiness for regulatory agency inspections
  • Supports Medical Affairs with internal or external routine audit activities and document reviews.
  • Foster commitment to quality in individuals and a culture of quality within the organization
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