Marie Murtagh
Director, Regulatory Systems, Operations and Promotion @Pacira BioSciences, Inc.
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WORK HISTORY
Director, Regulatory Systems, Operations and Promotion @Pacira BioSciences, Inc.
Member of the Regulatory Leadership Team (RLT) • Provide strong leadership with IT and Regulatory business process expertise to drive the ongoing transformation and continuous improvement within RA. • Ensure Reg Information tools and systems are implemented, validated, and maintained in accordance with company SOPs and applicable regulations. • Spearheaded training and video content to ensure seamless onboarding of team members. • Responsible for all submissions to be error free from a regulatory validation standpoint and are submitted on time to meet any internal or external requirements. • Responsible and accountable for implementing SOPs and work processes for publishing, submissions, and archiving. • Manage tracking and timely archiving of regulatory submissions and communications. • Identify, assess risks that can impact submissions and mitigate those. • Drive continuous process improvement through leadership of initiatives to capture learnings, identify opportunities for change and in partnership with global peers, develop a change management plan for implementation. • Partner with peers to increase visibility of upcoming submissions and deliverables across the regions. • Participate in the definition of requirements and evaluation of technologies and support system implementation as appropriate. • Assist with the development and implementation of standards for dossier management, publishing, archiving, metrics, and submission process for global health authorities. • Manage vendors and contractors as applicable to systems and technology project(s). • Oversee the development and execution of regulatory strategies and processes as it relates to advertising and promotional materials. • Oversee all aspects of Ad-Promo interactions with PCRC regulatory reviewers as appropriate to ensure successful review and approval of advertising and promotional materials. • Plan and manage regulatory submissions related to advertising and promotional materials.
EDUCATION
Saint Peter's University
BS, Business Management
Cornell University
Certificate in Women in Leadership, Leadership
ABOUT MARIE MURTAGH
I am a passionate, accomplished and results-driven Regulatory Operations Leader with over…
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