The Deloitte Consulting Quality and Risk Management Program (QRM) provides an integrated approach to help our practitioners consistently deliver high quality results to our clients by providing a comprehensive tool set for Quality Management and Risk Management. The QRM Mission is To protect the earnings, assets, and reputation of the firm, facilitate consistency of delivery, and reduce the cost of quality. Deloitte Consulting’s Cost of Quality has historically been driven by four key categories of risk:Client riskContractual/financial riskSolution riskTeam risk Effectively working with your QRM team throughout the lifecycle of your engagement will enable the proactive identification and mitigation of such risks designed to reduce the cost of quality.

Responsible for supporting various Deloitte Consulting practicesManage the negotiation and administration of large professional services contractsServe as liaison between firm leadership and the Office of General Counselresponsible for advising practice leadership on potential quality and risk management issues Provide guidance on risk mitigation strategies, contract formation and contract managementFacilitate internal compliance with contract terms, risk management policies and procedures, and management directivesFacilitate engagement review process for higher risk engagements and participate in pricing decisionsConduct Risk Consultations for selected higher risk engagements prior to proposal submissionHelp interpret contract requirements and obligations and provides guidance to engagement teamsNegotiate professional services contracts with a primary focus on reducing and mitigating delivery and contractual risks associated with the services being providedHelp interpret requirements of contracts entered intoMonitor compliance with professional standards and contractual obligationsAnalyze and assess potential impacts associated with contract delivery risksAssist in client negotiations with clients to resolve contractual issuesProvide guidance to reduce project risksAdjust contract requirements to accommodate changing project circumstances, and manage stakeholder expectations to contractual obligations and agreed upon performance standards

Responsible for driving the design and/or execution of strategic client business projects or processes. This person works directly with client teams, bridging technical and business components to create structure out of ambiguity and achieve client goals. A successful Consultant is adaptable, able to work independently, a good listener, and an effective leader and influencer. He or she tracks and drives results, and clearly communicates with client and project level stakeholders and management.Areas of AssignmentEnterey specializes in the Biotechnology, Pharmaceutical, and Medical Device industries. Engagements are related to:· GMP Manufacturing Operations· Quality Assurance· Quality Control· Supply Chain Operations· Acquisitions/Separations· Organizational Change Management· Data Management· Training· Regulatory· Other related business processes

♣ Experienced compliance professional with expertise in developing and implementing domestic and international compliance programs, performing assessments and compliance reviews, and advising healthcare and life sciences organizations on regulatory compliance. ♣ Expertise in healthcare, medical device and pharmaceutical regulatory compliance requirements and best practices related to the federal Physician Payment Sunshine Act, Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organizations, and related state laws regarding payments to physicians and hospitals, FDA device laws, PhRMA and AdvaMed Codes, FTC regulations, European Medicines Agency (EMEA), SEC, FD&C Act, Anti-Kickback Statue, Stark Laws, Medicare/Medicaid, HIPAA/HITECH, privacy and marketing, third-party reimbursement, state insurance and managed care laws and regulations, and related international laws, regulations and practices (United Kingdom, France, Belgium, India, and Denmark). ♣ Established protocols and procedures to ensure compliance with domestic and international regulatory agencies, including FDA, CMS, HHS, PhRMA, HEDIS, NCPA, OIG, NHS and ABPI (Association for the British Pharmaceutical Industry), European Federation of Pharmaceutical Industries and Associations (EFPIA), Danish Health and Medicines Authority (Sundhedsstyrelsen).♣ Extensive experience leading compliance initiatives relating to state and federal reporting requirements under Physician Payments/Sunshine Law and PPACA (HR3590), as well as in accordance with international reporting requirements. Responsibility for conducting assessments, developing transparency and disclosure programs, reviewing and analyzing domestic and international laws related to physician payment and expenditures, advising on technology (including system selection, implementation, and reporting configuration)

BEI: Bulls Eye Innovations (Rahway, NJ – 08/09-present) Project/Account Manager: BEI is a pharmaceutical solutions firm which assists pharmaceutical and medical device manufacturers with the development and implementation of a government disclosure and transparency compliance program as it relates to HR3590 (PPACA) reporting requirements• Develop, assess, and support transparency and disclosure programs of pharmaceutical, medical device, and biotechnology manufactures who must report economic benefits provided to health care providers and organizations (as per state and Federal HR3590 Reporting Requirements)• Coordinate resources, time and materials in order to adequately prepare an organization for state and federal reporting requirements pertaining to “Physician Payments/Sunshine Law” and PPACA (HR3590)• Respond to RFPs via the development of proposals and consequent scope of work• Responsible for the daily management of timely client deliverables, coordination of client meetings, project status updates, budget control, project invoicing, internal resourcing, and responding to client requests• Regularly interact with clients via live meetings, teleconferences, client site travel, and industry conferencesProgram Manager for the Aggregate Spend Alliance (ASA): The ASA is a professional industry organization sponsored by BEI, which facilitates a platform for industry executives to share their experiences about the development of their compliance and government disclosure program• Develop annual program and content for the alliance • Create and publish monthly news letter articles and advice columns• Create and support business development initiatives to gain new alliance members• Develop and publish marketing materials to printing and delivering• Partner with government and legislative bodies for disseminating industry compliance implications

* Business Development - product demonstrations, opportunity identification for new product or services, RFP reponses* Scoping solutions/WO creation - working with customer to identify scope to address specific business needs and working internally to get through WO creation* Client Meetings* Services Coordination/Daily Operations* Internal Meetings-prep for client meetings, staff meetings etc (all internal meetings not covered elsewhere)* Account Governance - Contract Change Mgmt, QBRs* Escalation Management - client and internal efforts* Finance - invoicing, forecasting, etcProgram/Project Management Tasks* Project Planning* Project Meetings Client* Project Meetings Internal* Program Management - coordination across multiple projects (ie there are TPMs/PM assigned to individual projects but SDM is serving as the integrator)* Product and Services Integration - coordination between the delivery of the application and the ongoing service teams(helpdesk, hardware, training)* Product Integration

Strategyx Inc, an inVentiv Company: Managed Care Strategy Senior Analyst (Somerville, NJ - 03/07-11/08)• Regularly interacted with clients and the internal consulting team to develop product, market segment, and communications strategies, with specific expertise within the managed care arena, product launches, competitive strategies, brand optimization, payer messaging, situation and environmental assessments, and product placement• Lead qualitative and quantitave market research projects, including discussion guide development, interviews, analysis and report writing for major players in pharmaceutical and biotechnology: Allergan, Biogen, BMS, Boehringer Ingelheim, Endo, Forest, GSK, Sanofi-Aventis, Johnson & Johnson, Mentor, and others• Analyzed qualitative and quantitative market data to develop situation analyses and backgrounders for both client projects and business development needs • Assisted in business development efforts, including development of project concepts and proposals• As training coordinator, assessed training needs of employees and implemented training programs to meet employee needs on various topics and developmental areas

The Hobart Group: Managed Care Strategy Senior Analyst (Gladstone, NJ - 02/09-05/09)• Assisted the Uroxatral (Sanofi-Aventis) brand planning team to provide educational field support in managed care initiatives regarding life cycle maintenance• Created a syndicated value definition analysis for 15 pharmaceutical and biotechnology companies which assessed the customer (pharmacy benefit managers, pharmacy and medical directors, formulary directors, clinical pharmacists, pharmaceutical contracting managers and case managers) perception of managed care representatives’ (NAMS, RAMS, AMS) account management behavior• Completed a quantitative and qualitative national and international managed care market research study assessing the competitive landscape for Novartis’s to-launch traveler’s diarrhea topical vaccine patch prior to market approval in order to develop an effective managed care strategy for product placement