When you work for Quintiles you work for the world's leading Pharmaceutical Services Company. We offer product development and commercialisation services to the Pharmaceutical, Biotechnology and Medical Devices industries. Our leading-edge capabilities provide healthcare companies with the potential to bring new medicines/devices through development and registration to the market place more quickly, with supporting medical and drug data that will significantly advance the cost effectiveness and quality of healthcare provision. Of the world's top 30 best-selling drugs, Quintiles has helped to develop or commercialise every single one.
RESPONSIBILITIES
Specific responsibilities may vary across individual positions. Typical responsibilities of this job classification include the following:
· Review and negotiate site regulatory documents and contracts with sites and sponsors for agreement on wording and budgets.
· Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.
· Review and provide feedback to management on site performance metrics.
· Serve as contact for investigative sites, designated project reports, communications, and customer service.
· Resolve site issues and determine status for product shipment.
· Work with regulatory team members or sponsor to secure authorization of regulatory documents.
· Work with legal team members or sponsor to secure authorization of contracts.
· Work with Clinical Operations, Project Management and Site Identification on SSU project specific status and deliverables.
· Inform team members of completion of regulatory and contractual documents for individual sites.
· Work with team members in preparation of regulatory submissions per work instructions.
· May serve as a SSU Team Lead for country or region as needed. Coordinate activities for projects within area of specialization.
· May translate or review completed translations of critical documents.
· May participate in feasibility and/or site identification activities.
· Local language is a must
