Establishing new value proposition for Pharma Hub business, focused on analytics/data insightsCasting vision for integration of patient reported outcomes (PRO) and data analytics product offerings into Pharma Hub spaceDeveloping and selling PRO product offering as differentiator for Cardinal HubWorking strategically with Pharma manufacturers to provide brand strategy solutions using Hub dataRebuilding client relations group to drive consultative account management via data driven insightsResponsible for Pharma Hub (Access and Patient Services-Sonexus) P&L management and disciplineLeading process optimization to drive EBITEnsuring interdepartmental efficiencies between IT, operations, finance, and sales

Responsible for the management, fiscal growth and operations of the HEOR organization. Reviewing new business opportunities, oversight and accountability for project timelines, management of operations teams, support of physician leaders, and ensuring quality conduct and successful execution of HEOR projects. Serving as mentor to the HEOR staff and assisting them in execution of projects that exceed the customer’s expectations. Managing operations of projects within the HEOR business. Working collaboratively with regulatory, contracting, finance, and BD teams in order to manage timelines, all needs related to the operations of projects.Driving execution of high quality deliverables and publications, and providing excellence in customer service. Planning FY budgets, revenue projections and assisting with forecasting of activities (costs) for clients. This includes but is not limited to individual project budgeting, reconciliation, identifying new revenue opportunities and insuring profitability to achieve EBIT expectations. Working proactively with the Business Development Team to provide support on the offerings of the businesses, review of proposals, creating scopes of work for vendors and clients and defining and refining of service lines. Managing the feasibility process, including use of multiple data assets and knowledge sources.

Established SciComm team as a go-to insight generating group, serving the Marketing Communications consulting business within Cardinal Health Specialty SolutionsCardinal Health Specialty Solutions’ Rising Star for fiscal year 2014 (July ’13 to June ’14)Developed insight driven lead marketing initiative to deliver analytics insights to support consulting business development/salesLed, planned, and executed strategic publication planning effort across Pharma Specialty Solutions division, in collaboration with Chief Medical OfficerExecutive Director and founder of FOCUS magazine, a Cardinal Health - Healthcare Analytics bi-annual thought leadership marketing pieceBuilt cohesive, high-performing Scientific Communications team to serve Specialty Solutions division, and establish thought leadership in specialty drug marketDeveloped relationships with clinical thought leaders in the oncology, hematology, and urology therapeutic areas arenas to stay current on clinical developmentsWorked cross functionally with all other Specialty Solutions business units to leverage insights from scientific communications for business development

Strategic scientific communication planning and execution for reimbursement presentations to medical directors (i.e. Blue Cross Blue Shield), and scientific presentations for global conferences and congressesPresented clinical data at international research forums (i.e. World Forum for Spine Research – Helsinki)One of two total (out of 800 employees) LEAN process efficiency award winners at OFIX – Purple Belt Identifying and negotiating with CRO for post market studies to maintain CE markPublication planning and execution based on business needs, target journal etc.Developed regional strategic marketing plan based on leveraging clinical data to target specific US areasWorked closely with marketing department to develop key marketing materials for sales force focused on clinical data and publicationsIdentified products where published clinical data would increase market share Planned and executed on strategies to publish retrospective clinical data to show evidence of value in products needing leverage

Led launch of Global Quality, Regulatory, and Clinical group based in AmsterdamResolved compliance, clinical, and regulatory issues through successful coalition buildingLed global, interdepartmental product obsolescence effort based on myriad of business concerns including gross profit margins and clinical trial costsDesigned and implemented regulatory strategies to obtain, maintain, and extend product registrationsInvolved in the creation and submission of documents to global regulatory authorities and notified body (e.g. FDA, BSi etc.)Served as a liaison with global regulatory authorities to develop effective relationships; Arranged and led meetings with global regulatory authoritiesContributed to the development and execution of clinical trial protocols Worked with the project team to develop appropriate scopes, timelines, budgets, and resources to meet trial objectives Participated in the assessment, qualification, and recommendation of clinical trial vendors (e.g., Contract Research Organizations [CROs], laboratories, etc.)Monitored progress of clinical trials and how they are conducted, recorded and reported versus the protocol, standard operating procedures (SOP), good clinical practices (GCP), other applicable regulatory requirements and timelinesManaged internal resources, external partners, consultants, vendors, and budgets to support the timely, high quality, and cost-effective implementation of Quality, Regulatory, and Clinical Affairs activitiesLead and motivate Quality, Regulatory, and Clinical Affairs colleagues by providing feedback and coaching to enhance or improve performance by setting expectations and holding individuals accountable for their performance

Led launch of global department of strategic scientific communications overseeing statisticians/publication managersWorked closely with Clinical, Regulatory, and R&D groups in EMEA to determine business needs via product optimization, gross margins, and market trendsServed as liaison to notified body in EMEADesigned, and planned EMEA clinical trialsSuccessful author of $2.4 million Department of Defense grant for clinical trialResponsible for publications and downstream marketing of all products globallyInitiated department launch by coordinating with various internal departments including sales, marketing, medical education, research and development, regulatory, and clinicalDeveloped successful global SOP for publication submissionsMet with international key opinion leaders to discuss strategic publication/product branding plansDeveloped sales training program specific to publications/scientific communicationsDeveloped online resource library as means to equip/educate sales forceResponsible for overseeing submission of all FDA required annual reports

Worked closely with sales force to develop clinical educational materials for Ortho Recon productsMet with key opinion leaders to discuss strategic publication plansHelped drive important business objectives through publications on Ortho Recon productsManaged seven retrospective clinical trials, each resulting in manuscriptsAuthor and Project Director for grant application to Department of Defense resulting in $2.4 million for clinical trial to study open fracture wound treatmentWorked with Chief Compliance Officer to develop foundational procedures to plan launch of in-house publications groupWrote and edited post market clinical follow up plans for dossier submissions to notified body in EuropeLed Clinical SOP improvement task force team for Clinical Affairs department

Study manager for FDA regulated post market approval study and multiple clinical studiesStudy monitor for FDA and non-FDA regulated clinical studies Author and Project Director – Small Business Innovative Research (SBIR) Grantso Up to $850k in fundingo Initiated project ideas, and assembled team of scientists and product managersServed as biostatistician for all company related clinical studies and preclinical analyseso Avoided 3rd party contracting and saved company over 35k in first yearMet with key opinion leaders to discuss both current and potential future projectsDesigned educational curriculum for sales staffWrote and edited IDE, 510k, and PMA submissions to FDAWrote and edited post market clinical follow up plans for dossier submissions to notified body in Europe

Studied mechanisms behind success of exercise as therapy for diabetesStudied effects of pharmacological manipulation (nitric oxide activity) on C2C12 myotubesStudied effects of NOS transgenic mice on muscle fiber typeStudied effects of satellite cell enhancing supplement on muscle recovery following perturbation in human subjectsStudied effects of exercise on neurotrophin modulation (BDNF) for multiple sclerosis patientsDeveloped strategic publication plan and wrote manuscripts for journals (AJP, J Physiol etc.) and abstracts for society meetings (EB, ACSM)Performed statistical analysis of research studies (SPSS)Wrote and contributed to extramural grant submissions (NIH, National Multiple Sclerosis Society)Responsible for study protocol development and IRB document editing and submission

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