Integration Procedural Documentation Manager - FSP

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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.