.Pfizer VP, Quality & Compliance, RWE Platform in Bothell, United States The Real World Evidence (RWE) Platform:The Chief Medical Affairs Office's RWE Platform is responsible for establishingglobal scientific leadership and staturethrough the generation of integrated, end-to-end observational real-world evidenceserving all therapeutic areasfrom proof of concept (POC) trials through Loss of Exclusivity (LOE) for priority pipeline candidates, pipeline supplementation through business development, and marketed inline products. The Platform fully centralizes RWE, epidemiology, outcomes research, RW-relevant health informatics, and biostatistics talent from global, international developed market(IDM)and emerging markets(EM)into one team to drive quality and efficiency through internalized work.ROLE SUMMARYThe RWE Platform Quality & Compliance capability pilar is responsible to ensure all RWE activities related to observational research studies, hybrid interventional and/or RWE trials comply with all applicable quality regulations, codes and standards, and upholds a quality and Integrity focused culture in which each person is required to carry out their responsibilities with proper regard for quality and to ensure the highest priority is placed on the safety and efficacy of our products, the safety of our patients, the integrity of data, and the trustworthiness of interactions with our Stakeholders.The VP RWE Platform Quality Compliance roleleads a team of Sr Director through Manager-level quality specialists in therapy dedicated teams and subject specialized areas.The VP's leadership team will serve assingle points of contact for all RWE Quality & Compliance needs as articulated in the RWE Quality & Compliance division documentation (quality plans/manuals, SOPs, protocols, etc.) describing how they execute the QMS for regulated activities within their area, meeting the minimum requirements defined for the RWE QMS.The VP will beresponsible for collaborating with Pfizer's Senior Leadership cross functionally to understand and translate health authorities' perspectives on the regulatory use of RWE and the release of new RWE guidance and develop actionable business processes to ensure high quality and timely delivery of compliant RWE projects. The head develops KPIs and success metrics with each of their Platform Leadership colleagues. They then direct their teams to work in highly-matrixed cross-functional teams to review the design and study concepts of draft protocols for RWE and compliance with Pfizer standards.This leader will also work across other Platform capabilities' senior leaders and in collaborations with Platform peers including VP's and Heads of Evidence Strategic Planning & Business Operations, RWE Clinical Affairs & Clinical Operations, and RWE Platforms & Partnerships
