Top 3 Must Have Skill Sets:
• Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance, including US Certificate of Pharmaceutical Product (CPP) knowledge
• 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
Needs to be very collaborative this role will communicate with many stakeholders across the organization
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
• Responsible for maintaining the on-site US Certificate of Pharmaceutical Product (CPP) responsibilities, as well as hard copy pickup at company and mailings.
• 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
* Individual must be good in communication and able to work on multiple tasks.
* Supportive to the team members.
I would like to have another team member to be part of interview panel as well.
*Urgent request looking to hire
PAY RATE : $22-$24/hr on W2
"This posting is for Contingent Worker, not an FTE"