Providing consulting services related to Clinical (eTMF/CTMS), Regulatory, QMS/Quality and Ad/Promo technology. My skill set includes product management, professional services, marketing/thought leadership, and sales engineering.

Responsible for the design and development of Ennov's eTMF and CTMS solutions and their associated deliverables. Also served as interim product manager for Ennov's QMS/Quality Documents product and contributed to marketing/though leadership with many blog posts, white papers, and webinars.

Responsible for the design and development of IQVIA ePromo solution for the review, approval, dissemination and withdrawal of promotional and medical materials. Work with clients and prospects to continue enhancing Wingspan eTMF, the industry's most advanced eTMF, to help clients increase compliance, efficiency and insight. Also responsible for eREG, which provides a new paradigm for the creation and management of eCTD compliant content, and SiteZONE, Wingspan's site document exchange portal.

Product manager for Wingspan's industry-leading cloud based eTMF. Responsible for defining product direction based on client feedback, regulator guidance, technology advances, and other research. Led the re-development of the eTMF user experience to provide a commercial-style UI and incorporate lessons learned from high volume usage of our product by some of the largest companies in Life Sciences.

Responsible for building an innovative pipeline of product advancements in support of the company strategy based on market and specific customer input for the NextDocs Regulatory and Quality product lines.

Responsible for designing, managing and delivering strategic and tactical services related to electronic submissions. Responsibilities included developing and delivering materials for eCTD Readiness assessment, Regulated Product Submissions and FDA review process for electronic submissions. Provided training and consulting services to a number of GlobalSubmit’s clients.Also served as the manager of the Product Development team and as the manager of Product Support.While at GlobalSubmit, primary author of the blog The eCTD Summit.

Practice Lead, Life Sciences Subject Matter Experts and Business AnalystsSenior Subject Matter Expert in R&D/Submissions, Quality and Manufacturing, Clinical Trials Document ManagementResponsible for the design and development of FirstDoc for R&D, FirstDoc for GMP/Quality Management and FirstDoc for TMF. Led teams who designed these products by bringing together industry knowledge, client experience, and best practices to develop system requirements. Developed delivery methodology, requirements documentation, workshop materials, and training materials and trained team in how to use them.Worked with dozens of pharmaceutical companies in the United States, Europe, Japan, and Israel to provide system requirements definition, system design, configuration, validation, and training for FirstDoc systems.Managed the Subject Matter Expert group, providing line management, coaching and mentoring to about a dozen FCG subject matter experts and business analysts in FCG locations in the US and Europe. Developed a reporting and management infrastructure within the practice allowing delegation of management and career development of the more junior team members to trusted senior associates. Managed staffing and utilization for the practice. Created training materials and conducted training sessions in both domain areas (such as CTD/eCTD and GMP) and in FCG’s product technology. Implemented best practices improvements sessions for the practice that served to improve FCG’s product and the processes and documentation used for projects. These sessionswere also instrumental in onboarding new hires by exposing them to actual client business problems and solutions.Represented the practice on the Life Sciences Operating Committee.Developed an information infrastructure and roadmap for processes and documentation used by the practice in requirements development, prototype evaluations, and user training. This was implemented using SharePoint and a Wiki.