As the Manager of Contracts and Network Development, I drafted and negotiated value-based and fee-for-service hospital, physician group, and ancillary service agreements for Medi-Cal/Medicaid Managed Care, Medicare Advantage, and Commercial product lines. I also managed the Contracting, Provider Relations, and Customer Service teams serving both health plans and an FQHC clinic system. I was responsible for identification and execution of contracting strategy and addressing regulatory compliance for state and federal requirements.

I work with hospital clients to identify and address potential stark, antikickback, and fraud and abuse violations. Additionally, I have worked with in-house counsel to establish compliance with new rules for facilities financed with tax-exempt bonds. I've managed the compliance review of contract portfolios for multiple mergers and acquisitions and negotiated multiple complex agreements and settlements.I also advise life sciences clients on domestic and international regulatory compliance issues ranging from data protection and privacy to FDA regulations and related laws and regulations in foreign countries.

As corporate counsel, I advised business leaders on HIPPA/HITEC, SOCII, privacy, and 21st Century Cures Act compliance. I was the head of the Corporate Compliance program developing healthcare IT compliance policies and procedures. I was also primarily responsible for drafting and negotiating healthcare licensing and data sharing agreements.

As a contract manager, I managed the development of a high volume of technology and IT contracts. I also managed relationships between business partners and vendors providing guidance and support to address complex contractual issues and disputes. As part of my role, I also advised business owners on contractual issues, regulatory risks and mitigation strategies.

I provided pro bono legal represenation to families in guardianship proceedings

As contract legal counsel, I advised hospital leaders on healthcare regulatory compliance, technology, and privacy issues including finance, HIPAA and privacy, Stark and Anti-kickback laws, and other ethics issues. I also developed and oversaw the implementation of multiple compliance initiatives.

Provided legal support for the development of an electronic consent-to-treatment program using EPIC electronic health records. Assisted Hospital Counsel on compliance and audit related issues with HIPAA, Washington Apple Care and Medicaid, Medicare, copyright infringement, and 340B Drug Pricing compliance. Drafted summary of Washington Uniform Power of Attorney Act for Hospital compliance.

Assisted general counsel to establish compliance with EU-US privacy shield framework to ensure continued research data transfer from EU partners. Independently researched and developed a plan for international data import/export related issues. Reviewed and assisted drafting contracts in areas including research collaboration, confidentiality, employment, and clinical trials. Assisted in drafting clinical trial agreements and patient consent agreements. Assisted with patent portfolio review in preparation for entering FDA clinical trials.

Project manager for the development and implementation of 21 CFR part 11 compliant drug production management software. Responsible for planning and managing the development cycle of regulatory compliance initiatives for multiple domestic and foreign drug manufacturing facilities and responsible for strict adherence to budgets and timelines. Developed and implemented procedures as a multigroup team reducing regulatory audit findings by 75 - 90% across all manufacturing sites. Successfully drafted several responses to the FDA following inspections and Notices of Event avoiding further actions by the agency. Served as Quality Systems Officer responsible for training staff and ensuring compliance with federal, state, and municipal regulations including FDA, DOT, OSHA, NRC, FAA. Key member of team responsible for the development and implementation of documentation for the submission of drug approval process in Japan and several European countries.Previously served as lead chemist for the production of FDA approved nuclear pharmaceutical drug for detection of Amyloid plaques. Responsible for all aspects of drug production including quality control testing. Radiation Safety Officer and Quality Systems Officer for production facility responsible for maintaining regulatory compliance. Lead organizer of production improvement group collaborating with other production facilities to facilitate improved efficiency and address production issues. Managed daily operational activities of research lab for the development of nuclear pharmaceutical biomarkers including supply chain management. Implemented and maintained disposal program and procedures for storage and disposal of hazardous and radioactive waste.

Under the direction of Denis Proshlyakov PhD, I headed a research project for his team studying the uses of a synthetic lipid molecule, DMPC, in molecular study using advanced spectrophotometric analysis. Applications for this study included amino acids, aromatic molecules, as well as proteins and enzymes. As head of the project, I was independently responsible for design and execution of research projects, data analysis, and reporting of results including public presentation and written reports.I was also responsible for maintenance and upkeep of laboratory equipment including (but not limited to) spectrophotometers, centrifuges, scales, pipettes, water baths, sonicators and gas exchange apparatus. In addition I was independently responsible for ordering and maintaining supply inventories and maintaining OSHA and ORCBS (Office of Radiation, Chemical, and Biological Safety) standards within the lab.I supervised two different individuals conducting supplemental work on the project and co-collaborated with several laboratories within the university.