“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"