Job Description
Post-Trial Access Manager, Continued Access is accountable for the execution of multiple global PTA programs, of mild and moderate complexity, with minimal supervision.
PTA here refers to the provision of investigational product for the intent of treatment, in a non-trial setting and under the care of a physician, following participation in a trial. PTA by this definition is governed by local laws and regulations and may be provided by established regulatory mechanisms such as early access, named patient programs, and other pre-approval access and managed access programs.
**Summary of the Essential Functions of the Job**
+ Develop and manage timelines and budgets for post-trial access (PTA) programs supporting investigational products prior to regulatory approval
+ Ensure compliance with regulatory requirements and company Policies/SOPs
+ Lead cross-functional teams and serve as primary program contact for PTA/Continued Access programs
+ Populate PT...
PTA here refers to the provision of investigational product for the intent of treatment, in a non-trial setting and under the care of a physician, following participation in a trial. PTA by this definition is governed by local laws and regulations and may be provided by established regulatory mechanisms such as early access, named patient programs, and other pre-approval access and managed access programs.
**Summary of the Essential Functions of the Job**
+ Develop and manage timelines and budgets for post-trial access (PTA) programs supporting investigational products prior to regulatory approval
+ Ensure compliance with regulatory requirements and company Policies/SOPs
+ Lead cross-functional teams and serve as primary program contact for PTA/Continued Access programs
+ Populate PT...