1. KEY ACCOUNTABILITIES AND RESPONSIBILITIES:

The main responsibilities are composed of three parts; [1] IIR & CTP (Compound Transfer Program) Coordination, [2] NIS management, [3] Medical Scientific Communication, as is already functional in some pharmaceutical industry organizations and [4] Scientific Support for Marketing Management.

[1] IIR & CTP Coordination

•   Manage the whole operational process of IIR and CTP

•   Proactively communicate with the investigators regarding the operational aspects of IIR

•   Support the review of the proposal by Medical Lead (ML) or Medical Manager (MM) through searching the supporting literature and related studies inside or outside of Pfizer

•   Assist ML or MM in encouraging the investigators to be involved in the preclinical study of the compounds in its early-stage of development

•   If the proposal is well-structured and the investigator is proven compatible in local PCO level, MSR writes the approval letter in cooperation with ML or MM and gets the approval of ML  and forwards it to the regional/global team

•   If the PCO review decides the proposal not-feasible, writes the declination letter in cooperation with ML or MM, acquires the approval of ML, accompanies in-house physician’s visit to the investigator to explain the decision of the review

•   In review process, keeps constant contact with the regional/global IIR manager and if required, regional Director of Medical Affairs for review

•   Once the proposal is forwarded to the GRC, MSR and/or ML or MM attend the GRC

•   In global GRC, MSR and/or ML or MM represents the proposals and defends it

•   After global GRC, proactively communicates with the investigator for the outcome of the GRC; approval, revision or declination

•   Until the approval and the actual shipment of the compound if needed, MSR oversights the whole process and track the process

•   MSR oversights the contract process.

•   Order and distribute the drug of assigned amounts to the study sites

•   Periodically send out the study status update form to the investigators to check the status of the study

•   Publication/amendment is locally reviewed by ML or MM, and MSR will support the documentation using the standard template.