Integration Procedural Documentation Manager - FSP
Primary Location: Brazil, Remote Job ID R0000040304 Category Clinical Trials
About this Role
Job Summary
The Integration Procedural Documentation Manager works with SOP Acquisition Lead to assist in the coordination of the assessment and transition plan for possible integration of procedural documentation into the Sponsor's SOP model for clinical, medical, safety, regulatory, and quality management system processes relating to business deals.
Job Responsibilities
· Developing SOP mapping between Sponsor's SOPs and the aquiree’s sponsor/contract research organization (CRO)/vendor procedural documentation
· Conduct comparison assessments between the procedural documentation to identify major gaps and work with the business process owner and SOP authors to validate
· Facilitate the risk assessment of gaps with the business and document any interim procedures to mitigate the risk
· Develop the official transition communication (using templates)
· Develop the retirement strategy
Qualifications:
· BS/BA Degree plus 5+ years Pharma experience.
· Demonstrated experience in project management and implementation techniques.
· GxP experience and a strong working knowledge and understanding of drug development processes.
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