-Leader in the biopharmaceutical industry and a trusted advisor to clients with accountability for REMS lifecycle services associated with overall program account management and thought leadership-Setting business direction, strategy, and priorities to drive the growth and scalability of the Global Risk Management & REMS services and capabilities -Identifying client needs, design strategic and innovative solutions, manage client deliverables, coordinate with other internal program representatives, and deliver client contracts on time, on budget and within scope -Establishing and maintaining the Global Risk Management & REMS Account Management team approach, structure, and goals-Building a high-performing team, find and nurture talent, maintain succession plans, and provide performance coaching-Overseeing team’s project schedules and resource allocations for all GRMR projects and drive successful delivery of project commitments

-Lead safety risk management strategy and activities, including US REMS and EU RMP measures-Collaborate with cross-functional teams to implement program processes and assessment of effectiveness of programs-Engage with external experts to drive standardization in the industry and inform regulatory direction

-Overseeing of US Risk Evaluation and Mitigation Strategy Program (REMS vendor management, project management, regulatory reporting, operations monitoring and compliance oversight following the successful launch of the REMS)-Managing Independent and Collaborative External Research Programs-Leading cross-functional teams to execute time-sensitive, highly regulated programs globally, including companion diagnostic for gene therapy-Establishing a process for and executing risk mitigation materials development, distribution and tracking outside the US, including RMP aRMMs and name patient sales-Supporting the operations/process refinement for our independent medical education program

-Implementation of global risk mitigation activities including REMS program and EMA RMP Risk Materials-Pre-approval activities, implementation and ongoing management for the Biomarin REMS programs-Oversees vendors and leads cross-functional REMS Implementation team (including PV, Regulatory, Commercial- Marketing, Market Access, Patient Services, Sales Operations, Legal, etc.) to support finalization of REMS, planning for implementation and operationalization of the REMS-Process management and coordination for the REMS Regulatory Submissions-Supports ex-US cross-functional teams to support Risk Management planning, materials/submission documents/implementation as needed-Coordinates internal audit and regulatory inspection activities-Additional Medical Affairs activities including improving the Continuing Medical Education (CME) grant review process, Medical Congress and Conference support, and leading health literacy initiative

-Strategic and operational management of the Zydelig and Truvada PrEP REMS programs in compliance with FDA guidelines:-Ensuring deliverables are completed on time, within budget, and in accordance with REMS vendor contract(s), SOPs, quality standards and REMS FDA requirements and regulatory guidelines-Organizing and maintaining REMS project specific staff training and REMS program associated documentation (eg; SOPs, approvals, supporting documents, educational materials)-Developing and revising of REMS process workflow development, SOPs, and audit/inspection support-Adapting programs to meet evolving international and FDA guidance and regulations for safety surveillance, risk management and REMS requirements-Partnering with 10+ generic companies to prepare for launch of multi-sponsor single shared system (SSS REMS) -Project management for Argus 8 upgrade to meet E2B R3 requirements as well as other technical projects for department including e-signature and electronic training documentation

-Strategic and operational management of the Myalept REMS and Symlin REMS programs in compliance with FDA guidelineshttp://www.myalept.com/rems.aspxhttp://www.symlinrems.com/

-Strategic operations management for patient assistance programs that provide free oncology, virology, cardiovascular, neurological, and metabolic medications to uninsured and under-insured patients in the U.S-Constructed corporate social responsibility strategy based on the projected financial and operational impacts of near and long term expansions of health insurance as a result of healthcare reform, with focus on facilitating continued access for patients to medication-Project management for the BMS Foundation website for uninsured patients to find patient assistance program information: http://www.bmspaf.org/ and healthcare insurance coverage calculator for BMS medications, focused on patient's insurance needs: http://www.bms.com/products/Pages/programs.aspx

-Managed or co-managed all aspects of 14 rheumatology phase II and III drug trials for over 90 patients at large private clinic following ICH GCP

Created cohesive digital reports using data from collaboration with multiple laboratories (immunohistochemistry, flow cytometry, cytogenetics), resulting in patients receiving comprehensive oncology diagnoses

Created drug that inhibits inflammation in disease models, such as diabetes and allergic reactions, by analyzing data and identifying ways to modify molecule to increase cell-permeability

Developed solutions for product queries from customers to increase repeat customer business