Lead engagements in the following areas of expertise:REMS Strategy, advising Regulatory and Commercial leadership on the need for a REMS, program design, FDA negotiations, and REMS administrator system selectionShared Safety Program Management, implementing operations and oversight infrastructure to support direct competitors working together on programs required by regulatory agencies to market product Medical Affairs Strategy, helping leadership assess and refine processes for operational excellence, compliance with regulations, and implementation of supporting technologiesLaunch Management, guiding Commercial and Regulatory teams to work with internal and external stakeholders to plan, coordinate, and execute new product launchesChange Management, providing strategic guidance on large-scale system and/or organizational changes, as well as project management

Faciliated discussion and decision-making among multiple groups of directly competing manufacturers working together on required post-marketing safety programs (REMS, RMPs) in order to guide day-to-day operation of their complex programs, including financial and contracting management Engaged with regulatory agencies with and on behalf of clients, serving as a risk management expert and providing strategic guidance to support patient access to medications with complex risk profiles Led a large team of consulting managers and individual contributors, guiding Risk and Program Management Advisory Group operations, talent development, and business development Presented to FDA and DIA on best practices in development and operation of REMS programs

Served as a trusted advisor to manufacturers considering their strategic options for products with complex risk profiles that may require a post-marketing safety program and the associated regulatory oversightGuided clients and consulting teams in developing, rolling out, and operating new and modified REMS programs, including the related FDA negotiationsEnabled rapid growth of Risk and Program Management Advisory Group, both through business development and by leading talent recruitment efforts

Led day-to-day operations of program management offices for large-scale regulatory programs on behalf of consortiums of pharmaceutical companiesOversaw REMS administrator development of custom of REMS technology platforms that required compliance with both regulatory and IT security regulations

Oversaw financial, strategic, and tactical operations for three internal departments serving the editorial, knowledge management, and research needs of more than 200 biopharma consultants

Supported multiple large scale implementations of clinical technology systems, such as EDC and CTMS, including technology vendor selection and management, business processes redesign, data migration, system testing, and training development and rolloutConsulted on process improvement projects for Clinical Development and Medical Affairs, reviewing, writing, and harmonizing standard operating procedures (SOPs), work instructions (WIs), and other process documents

Led team of writers and editors who reviewed all deliverables and proposals for consultants working in Medical Affairs, Clinical Development, Managed Markets, Sales Strategy, and Commercialization StrategyDeveloped and implemented editorial standards, templates, and detailed quality assurance processes that were implemented by the team of writers and editors that I supervised

Ensured application of robust strategic thinking, clear messaging, and effective document design for proposals and client deliverables for more than 600 Clinical Development and Medical Affairs projects

Led Marketing Department at a boutique management consulting firm serving the Fortune 500, creating proposals, presentations, and other collateral

Served the public relations, marketing, advertising, and design needs of clients in the consumer products space