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Summary

Highly accomplished, results driven professional with 10+ years of pharmaceutical industry experience, specifically 6+ years of involvement in Transparency initiatives including Aggregate Spend and HCP Payment Disclosure requirements implemented by the OIG-CIA, CMS, EFPIA, FDA and other regulatory agencies.  Specialized in increasing reporting efficiency and enhancing data quality for Sunshine Act, Transparency in Grants (TIG), State Reporting and Financial Disclosure (FD) obligations.  Proactive leader who shows fresh, insightful thinking by developing strategic and analytical approaches to challenging problems.  Technically advanced and holds experience with launching and improving several Pfizer systems. Relevant continuous improvement projects include strengthening upstream processes and data system revisions to ensure data integrity, timeliness and improved reporting compliance.

Education

Sep 2015Present

Masters in Health Administration (MHA)

Columbia University- Mailman School of Public Health
20062009

Masters in Business Administration (MBA)

Long Island University - C.W. Post Campus
  • Electives focused on Finance, Accounting, and Management
  • Beta Gamma Sigma- International Business Honor Society

20022006

B.S. Degree in Chemistry - Certified by ACS

Duke University
  • Chemistry Major’s Union (VP), Phi Eta Sigma Honor Society (Community Service Director), Latino Student’s Association at Duke, Student Athlete Advisory Committee, and First-Year Advisory Council, Duke Club Lacrosse-Founder (2003), President/ Captain (2003-2006)

Work History

Nov 2016Present

Director/ Team Lead

Pfizer Inc. (U.S. Payment Transparency)
  • Ensure that Pfizer meets its United States disclosure obligations by leading the strategy and execution of the payment disclosure process ensuring data integrity and timeliness in meeting all reporting deadlines.
  • Responsible for ensuring the quality of the data in postings, filings and reports related to US Healthcare Professional (HCP) Payment Disclosure including Affordable Care Act (Sunshine) Reporting, State Reporting and Financial Disclosure. 
  • Lead a team of seven responsible for reporting on payment data from 80+ financial and project management systems across the organization and from 3rd parties, and oversee the operational aspects and resources dedicated to this work.
  • Collaborate with stakeholders as regulations and corporate procedures change to be aware of new and changing requirements and technologies, and develop solutions to support various transparency initiatives including the reporting provisions of the U.S. Sunshine Act.
  • Manage all aspects of the Centers of Medicaid and Medicare (CMS) submission process for Sunshine Payment Disclosure.
  • Maintain good relations with CMS to help shape future enhancements to the Sunshine submission and dispute processes and the Open Payments website.
  • Partner with Business Technology to ensure that source systems and Pfizer’s data repository, HCP customer master and other applicable Pfizer systems evolve to meet U.S. public payment disclosure requirements.
  • Represent Pfizer at industry conferences and / or professional organizations to help influence future disclosure policies.
  • Provide knowledge and expertise acting as subject matter expert for US HCP Payment Disclosure.
  • Collaborate with Legal and Corporate Affairs colleagues on responses to Media inquiries.
  • Negotiate with leaders, including those more senior, to ensure that processes are in place to collect and capture all required data for disclosure.
Dec 2015Nov 2016

Senior Manager

Pfizer Inc. (Medical Quality Assurance (MQA) Analytics and Reporting Lead)
  • Responsible for supervising and undertaking the implementation of complex metric strategies and reporting solutions.
  • Manage projects to improve usability, consistency, timeliness and responsiveness of current reporting technologies (PLP).
  • Lead initiatives that anticipate customers' urgent requests and implement solutions that re-engineer process requirements, automate operations and minimize business risk. 
    • Optimized MQA's investment in Trackwise by learning QTS Analytics, a tool that has introduced an efficient ad-hoc reporting option.
    • Re-designed template for CSR Audit Certificate FDA requirement.
    • Automated 'Observation' Control Charts to monitor stability and control of process quality; established measurable thresholds.
    • European Medicines Agency PV reporting improvements. 
    • Reduced manual efforts in BPO, QMS, BU, and Annual dashboards. 
  • Lead revisions to the audit management system to ensure the generation of business, operational and quality monitoring metrics. 
    • Created a QC Summary Report to highlight and resolve system issues.
    • Participate in User Acceptance Testing of new system enhancements.
  • Demonstrate expertise and guide functional groups to ensure reporting requirements are identified, designed, and distributed appropriately, highlighting and interpreting trends, and variances within the data. 
    • Partner with Business Technology, Audit Analysts, and MQA Audit Process Lead in the design and development of reporting strategies. 
    • Re-design metric strategy for Quality and Compliance Committee (QCC), Clinical, Medical Excellence and Innovation (CMEI), Executive Compliance Committee (ECC) and Board of Directors (RCC).

 

 

Apr 2013Dec 2015

Associate Director

Pfizer Inc. (Transparency - Financial Disclosure) 
  • Provided Financial Disclosure (FD) reporting for FDA marketing applications in compliance with regulation FDA 21 CFR Part 54.
  • Accountable for the creation and adoption of an electronic FD collection process, launched the FD Portal within Firecrest.
    • Automated online deployment of FD Forms to investigators.
    • Single platform for Pfizer and Preferred Vendors, enabling standardization and better compliance oversight.
    • Enabled near-time assessment on FD collection quality.
    • Developed training materials and provided Awareness Sessions.
    • Resulted in a reduction of costs of over 75% (>$220K/ year).
  • Implemented and streamlined a quality control report for monitoring, analyzing and resolving missing FD Forms.
    • Lead to a massive retrospective recovery of ~65K FD Forms.
    • Reduced pre-submission gaps from ~28% in 2013 to ~1.0% in 2015.
  • Collaborated on innovative system and process enhancements to improve FD payment searches across global financial systems. 
    • Developed “fuzzy match” logic for direct and indirect SAP searches.
    • Exposed new data fields from SAP and Computron to accelerate and automate decision-making. 
    • Reduction in process time by ~50% (120 Days to ~60 Days).
  • Analyzed and resolved compliance issues to secure alignment with FDA regulation and minimize business risk.
    • Extracted RTII Employment Category to identify Pfizer Staff.
    • Integrated a Due Diligence Form to document contact efforts.
    • QC Checklist for FD A4 List of Investigator identification process.
    • FDA Submission QC Dashboard focused on identifying payment duplicates, disclosure and due diligence issues, and quality concerns.
    • Built strong collaborative working relationships with CTPQ- Process Excellence, Dev Ops, GCP Compliance Mgmt., and Inspection Readiness to ensure cohesive activities regarding Form FDA 1572.
Mar 2010Apr 2013

Senior Associate

Pfizer Inc. (Transparency -Data Strategy & Reconciliation)
  • Participated in the implementation and data collection for the U.S. HCP Payment Disclosure, FD and TIG Transparency initiatives.
  • Assisted in developing the technological foundation to enable the aggregation and monitoring of HCP payments in accordance with Pfizer's CIA, Sunshine Act, and State Reporting Laws.
  • Collaborated with BT and BPOs on several source system enhancements to facilitate the extraction, matching, and reporting of HCP payments.
    • Negotiated changes to SAP and Ariba while assessing global impact; added HCP data fields, HCP attendee types and requested upfront user-access to the HCP Customer Master.
    • Aided in developing HCP Lookup and HCP Data Clarification Tools.
  • Assisted in the development, upgrade and post-monitoring of Pfizer’s Travel & Expense (PT&E) System and PT&E Mobile App. 
    • Developed FF PT&E Resource Materials (Breeze Presentations, FAQs).
    • Conducted UAT testing and provided recommendations that enhanced the productivity for end-users and increased data quality.
  • Executed Continuous Improvement projects that focused on automation, improved efficiency, cost reduction and data accuracy.
    • Implemented innovative Pre-Data Stewardship processes for PT&E that reduced clarification efforts from ~50K /mo. to ~1K/ mo.     
    • Downloaded Microsoft's Mail Merge Toolkit add-in to assist with HCP data clarifications (savings of ~25K/yr).
  • Yellow Belt, “Streamline the Processes of Capturing HCP Meal Payments within PT&E” (savings of ~2 Million/ yr.):
    • Established quality checks for misclassified HCPs and misallocated meal payments to improve colleague compliance with data entry.
    • Developed training and feedback loops to automate stewardship.
  • Yellow Belt, “Streamline the Transparency in Grants Process”
    • Referenced Interact and Policy Funding Review Committee decisions to establish and align important payment scope decisions.
  • Presented best practices to Global Transparency Community to facilitate the implementation of country transparency programs.

 

 

Oct 2009Mar 2010

Transparency Coordinator                                              

Pfizer Inc. (Transparency)
  • Assisted in designing the work flow and processes for aggregating multi-sourced HCP payments in accordance with Pfizer's CIA.  
  • Partnered with BT to build, test and source a HCP Transaction Repository
  • Supported Financial, Payment, and Clinical Trials Disclosure projects.
Mar 2008Oct 2009

Administrative Assistant II                                                     

Pfizer Inc. (Spiriva/ Viagra Marketing Teams)
  • Assisted with the launch of iCUE Wave 1 (Physician detailing application)
    • Developed web-based training (iCUE eLearning Modules).
  • Launched utilization programs to identify the ROI of Viagra Vouchers.
  • Contracted/ trained >700 Spiriva Speakers across the Pfizer/BI alliance. 
  • Pfizer Review Committee (RC) Coordinator
    • Pfizer Best Practice Award for creating "Viagra’s Adverting & Promotional RC Guidelines"; served as the model in establishing efficiency for on-boarding new marketing agencies.
    • Overlooked the migration to BI’s electronic TEMPO RC system.
Oct 2007Mar 2008

Project Coordinator – Merck Product Launch                        

GSW-Worldwide-Gerbig Snell/ Weishemier
  • Liaison between cross-functional teams to develop and implement tactical marketing plans across TV, Print, Online, and Direct Response Media with a combined budget of over $10 million.
  • Budgeted and maintained job estimates; reviewed financials regularly with client and account leads; negotiated and managed project timelines.
May 2006Oct 2007

Promotional Marketing Coordinator- Business Service and Analytics

All Things Traffic- Pfizer Inc.
  • Transitioned DDMAC/ FDA submissions from paper to an electronic format; resulted in an annual cost savings for Pfizer >50K/yr.
    • Streamlined the RC process with the introduction and training of an electronic management software (M.O.S.T).
  • Responsible for the translation, review and submission of over 160 promotional materials used in Puerto Rico
  • Collaborated with Distribution Managers and FF to launch PROMOS, a system used to regulate the outflow of promotional items.