Shannon Ledger Email & Phone Number

Philadelphia, Pa

• Ensured the smooth daily operations of the Regulatory Review staff, overseeing a team of ~40 employees dedicated to several of the agency’s largest and most demanding pharma clients.• Established monthly MLR process training series geared toward providing new employees from various capabilities with a solid foundation from which to build.• Oversaw the scenario planning, content review, and project submission strategy for multiple, overlapping launch initiatives.• Fostered an environment of collaboration and open discussion for those within the department to unearth fresh ideas and encourage growth.

Philadelphia, Pa

• Developed a comprehensive Regulatory onboarding process to ensure an effective and complete training experience for all new hires.• Interfaced with internal cross-functional teams and external clients as a strategic and trusted resource to bring clarity and problem solve on some of the agency’s largest digital projects to date.• Documented and presented client-specific Medical/Legal/Regulatory submission process, requirements, and tips for internal reference and training.• Collaborated with leaders across capabilities to customize and roll out a more efficient, digital ticketing system (JIRA) for Regulatory submission preparation.• Worked closely with clients to define and establish appropriate regulatory review procedures for new and evolving assets, such as responsive web design, social, and user-generated content.• Simplified and organized internal workflow to increase consistency and efficiency across an expanding portfolio of work.

• Organized and coordinated regulatory submissions for high profile launch brands with considerable workload demands and time constraints, maintaining high level of accuracy and quality of work throughout.• Improved department materials by evaluating key areas for improvement and creating clear and concise documentation to fill the gaps, including core competencies documentation for various levels within the department.• Analyzed and resolved discrepancies in weekly and annual allocation reports for the department, working closely and collaboratively with agency VPs, Directors, and Staffing.• Interviewed, on-boarded, and trained new hires.• Coordinated daily workloads and annual review processes for Regulatory Review Managers, Senior Associates, and Associates.

• Prepared, routed, uploaded, and linked submission packages for review by our clients' Medical/Legal/Regulatory (MLR) board via electronic workflow systems such as Veeva Vault PromoMats and Aprimo.• Guided agency creative work through MLR review process, acting as primary point of contact for all submissions needs and guidance.• Established effective timelines and assigned responsibilities to team members for delivery of regulatory submission components.• Developed a more efficient, paperless archiving system for the agency’s regulatory and compliance records.• Led initiative to improve internal process standards to ensure the overall quality and accuracy of creative deliverables in collaboration with fellow elected department leads.

• Developed and presented to management a system of successful best practice procedures, which were then established as standard process department-wide.• Mentored Junior Coordinators, promoting teamwork and providing advice and guidance in managing client expectations and project organization.

• Ensured quality of all documents and materials throughout draft, editorial, and production phases, ensuring RFP compliance, corporate identity compliance, high-quality photography, and accuracy in content.• Organized, edited, designed, assembled, and distributed large, custom documents in the ARAMARK corporate tradition, as well as creative pieces for various accounts under tight deadlines.• Assisted in archiving files, including job closure and billing.

• Coordinated closely with internal departments, senior management, and clients regarding project requirements and status.• Prepared files for print in Quark, Photoshop, InDesign, and Illustrator; designed and edited customized signage; mounted, cut, and finished large format signage and banners.