Expert in Systems and Processes in Clinical & Regulatory in Pharmaceutical, Healthcare and Health Insurance
Expert ID: 730589 New Jersey, USA
Expert is a CPA, member of AICPA and NYSSCPA. Expert has global experience with pharmaceuticals, focused on corporate integrity agreements and Physician Payment Sunshine Act, interacting with finance, audit, clinical and regulatory teams, physicians and non-physician investigators, CROs, universities and institutions, FDA, and legal.
Accounting system |
Expert analyzed and improved accounting systems and processes at International Finance Corporation, Prudential Home Mortgage, TriStar Pictures, MetLife, JPMorgan Chase, American Express, Ortho-McNeill Pharmaceuticals, Ortho Biotech, and Pfizer.
MetLife – Expert designed and executed a new system for MetLife to pay physicians in a new way. She was the sole performer of requirements, analysis, design, and test planning. She directed programming and user testing and initial data population of system. (1991-1992)
Management accounting |
Expert has global experience with both pharmaceuticals and financial services. Extensive experience with pharmaceutical company operations. Diverse work with financial services, including credit cards, mortgages and insurance.
Expert analyzed and improved General Ledger systems and reporting systems supporting International Finance Corporation, Prudential Home Mortgage and TriStar Pictures and General Ledger, Accounts Payable, Accounts Receivable, and Contracts systems supporting Borden.
Project management |
Pfizer, Inc. (10/1998 – 10/2011) Expert built new process and system to comply with 1998 FDA regulation on personal financial disclosure (FD rule) by investigators on Pfizer clinical trials worldwide. Financial disclosure (FD) system integrated financial information from investigators with data from Pfizer clinical trial systems and financial systems. Expert prototyped the FD process for the first major filing to FDA on time under new rule. She designed / implemented FD process / system for second filing., with a system delivered below budget (under $1 million) and on time (1 year). She achieved 100% compliance with regulation in all filings to FDA from 1999 to 2010, totaling approximately 100 filings.
Johnson & Johnson (Ortho Biotech and Ortho-McNeill Pharmaceuticals) – Expert performed detailed analysis of operations for a Y2K business continuity plan – including the functions of Manufacturing, Packaging and Distribution, Quality, Clinical and Regulatory Affairs, Sales, Marketing (General and Oncology), Human Resources and Finance. (1997-1998)
Expert wrote chapter, “Crunch Projects” in book, Amplifying Your Effectiveness, edited by Gerald M. Weinberg, Dorset House, 2000.
Six sigma quality |
Expert obtained a Green Belt in Lean / Six Sigma 2010 and achieved $1 million savings per year for business.
Pfizer – She created innovative business process and system to support a new FDA requirement from strategy to first delivery to ongoing operations. Continuous Improvement projects to streamline business processes saved $750K per year, earning Expert a Lean/Six Sigma Green Belt. (1998-2011)
Expert reduced cost of reporting for FD and other health care professional reporting, to address pressures to Pfizer’s bottom line. In a project spanning multiple business units and countries, Expert reduced the cost of collecting forms from clinical investigators working on Pfizer worldwide studies by $600K annually.
Expert coached other project leads and directed CROs, reducing costs of processes by $150K annually. Projects addressed issues in reporting on payments to health care professionals.
Pfizer Inc.: Expert developed specific requirements for Pfizer to report under Financial Disclosure by Clinical Investigators, 21 CFR Part 54, as well as Transparency for the OIG.MetLife: Expert worked from concept to implementation and delivery of the Capitation Payment System, which enabled MetLife to pay physicians in its HMOs.Ortho-McNeill and Ortho Biotech: Expert managed the survey of potential business impacts of the "Year 2000" or "Y2K" problem, enabling Johnson & Johnson's subsidiaries to surmount potential obstacles without any problems.American Express: Expert managed the relationship with managers and users at American Express as well as working in a more technical capacity from developing requirements through implementation.Borden: Expert performed a management review of the systems of Borden's new implementation, including General Ledger, Accounts Payable, Accounts Receivable, and Contracts.
|Year: 1986||Degree: MBA||Subject: Finance / Accounting||Institution: New York University|
|Year: 1974||Degree: BS||Subject: German / Education||Institution: Bucknell University|
|Years: 1993 to Present||Employer: Undisclosed||Title: President / Consultant||Department:|
Responsibilities:Expert consults primarily with Fortune 500 companies to support their business process and systems improvements.
|Years: 2004 to 2011||Employer: Pfizer Inc.||Title: Associate Director||Department: Financial Disclosure / Transparency|
Responsibilities:Expert was responsible for leading the development and improvement of systems and processes for Financial Disclosure and Transparency.
|Associations / Societies|
Independent Computer Consultants Association
|Licenses / Certifications|
|Uniform State Law Commission (NCCUSL), 1999 – 2002, Representative for independent computer consultants|
|Awards / Recognition|
|Chairman, Independent Computer Consultants Association|
|Publications and Patents Summary|
|Wrote chapter, “Crunch Projects” in book, Amplifying Your Effectiveness, Dorset House, 2000.
|German||I read and write fluently, and I speak moderately well.|
|French||I read and write moderately well.|
Fields of Expertise
accounting ethics, accounting system, management accounting, project management, six sigma quality, nonprofit organization, accounting fraud, public accounting, corporate accounting, accounting policy, HMO insurance, compliance, financial malpractice, 21 CFR Part 11, finance, knowledge management, document management system, incentive compensation plan, business intelligence, SQL database, enterprise resource planning software, enterprise resource planning, cost accounting, database design, regulatory compliance auditing, accounting, online information system, Structured Query Language, database development, database management, Food and Drug Administration, database management system, drug regulation, relational database, relational database management system, records management, Oracle, executive information system