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.