Audit And Risk Operations Coordinator, Commercialization AnalyticsThis role supports the Market Research (MR) Compliance Team under direction and guidance from the MR Compliance Lead, working cross-functionally supporting BI&A activities related to Market Research and GVP Activities to ensure that internal audits responses, the third party risk process, and reporting are performed accurately and with sufficient detail.
The role requires attention to detail and strong time management skills to ensure accurate and timely submissions. Specifically, this role will be responsible for:Development of an understanding of the regulations, methodology and processes that drive Market Research to ensure Client compliance with program requirements.Prepare and support audit activities for MR Pharmacovigilance Vendor and Affiliate audits and Inspections. Activities include working closely with PV Audit teams and vendor partners to ensure timely closure of Audit activities and continuous monitoring of trends.Manage internal vendor onboarding, including Third Party Risk Management (TPRM) process and system, which includes engaging vendor agencies in responding to requests and remediation of identified issues and escalating issues to the Compliance LeadOwn document tracking and data governance for requests; maintain schedule of deadlinesProvide reporting and analytical support to ensure Client compliance with government program regulations by tracking and monitoring on-going activities.Partner with internal stakeholders in order to provide status updates and manage expectationsImplement continuous improvement procedures to maintain operational effectiveness; making recommendations to strengthen and streamline the process and controls in placeQualifications and Expected Behaviors:BA/BS in relevant field of study or equivalent requiredExperience in an audit or compliance support roleAbility to enforce process and compliance standardsStrong communication skills in order to engage with teams on complex topicsIntermediate knowledge of MS Excel, specifically formulas, pivot tables and chartsDemonstrated ability to problem-solve in complex situations, gather potential solutions from a variety of sources, and synthesize to develop recommendationsDemonstrated ability to balance multiple projects simultaneously and work independently to deliver timely resultsExperience with pharmaceutical industry and/or pharmacovigilance is a plusStrong background in QMS, Compliance or Quality Assurance preferredExperience in working across cultures preferred