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Thousand Oaks, CA
“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and  puerto rico vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship this company, its operations, or its staff.”                                                        

Top 3 Must Have Skills                                                                        
  • Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory guidance and documentation
  • Basic understanding of the Veeva RIM Vault system
  • Good written and verbal communication skills
  • Independent time management and prioritization skills and detail oriented
  • Critical thinking skills
  • -Great organizational skills

Day to Day Responsibilities:                        
  • Key Activities: All, or a subset of the following:
  • Maintain Regulatory document management and tracking systems
  • Create/archive Clinical Trial and Marketing Application submissions/Health Authority correspondence
  • Point of contact between Regulatory Representatives/CMC and publishing teams
  • Ensuring Regulatory compliance with SOPs and Regulatory authorities
  • Provide support to RDA team members and other functional areas, including vendors
  • Collaboration with external partners/outsourced CROs
  • Responsible for creating, running, and analyzing report data for potential Veeva RIM system clean-up
  • Organize meetings and meeting minutes, monitor SharePoint to update non-controlled documents, and work within the Veeva CDOCS Vault system to update controlled documents for the Regulatory Data & Analytics (RDA) team

"This posting is for Contingent Worker, not an FTE"

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