San Francisco Bay Area
A results-driven compliance and quality assurance professional with expertise in managing regulatory programs, risk assessment, and process optimization. Adept at leading FDA BIMO inspection readiness, internal and external audits, and regulatory compliance for clinical studies. Skilled in developing SOPs, training teams on compliance requirements, and leveraging data analytics (Power BI) to drive informed business decisions. Passionate about data security, governance, and continuous improvement to uphold the highest industry standards. A strong advocate for diversity and inclusion, serving as a steering committee member and global program lead for cultural awareness and professional development initiatives.
• Manages compliance programs, defining milestones and success criteria, resource allocation and successful on-time delivery. • Identifies, assesses, and advises on compliance risks and controls to a variety of stakeholders and customers. • Creates and drives programs to tighten the data security and governance over our internal data. • Coordinates, manages, and facilitates compliance processes to provide timely deliverables. • Communicates schedules, priorities, and statuses to all levels in the company. • Participates specifically in FDA BIMO inspections and other regulatory inspections of clinical studies. • Lead for Back-room FDA BIMO inspections, fulfilling audit requests (+1K documentation preparation) • Assumes a leadership role for the preparation, execution and follow up activities related to internal and external regulatory audits, inspections. • Prepares and conducts external vendor inspections and audits and maintains the schedule or required audits to maintain compliance. • Analyzes deviations between SOPs and observed actions and determines if the actions must be corrected, SOPs must be modified, or creation of new documents. • Provides training and overall guidance to the clinical affairs organization on compliance requirements. • Demonstrates high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained. • Steering committee member for Asian Community Empowerment (ACE) employee resource group • Global program lead for ACE Pre-PAIR program focusing on cultural awareness and education, professional development and deliverables with a business impact • Developed Power BI Reports to drive business decisions (Monitoring Action Item Trackers, Audit Results) • Submits documents into internal Quality Management Systems (QMS) • Developed BIMO Audit Readiness Playbook for Investigational Sites and Sponsors
• Manages a professional staff which develops, establishes, and maintains processes and procedures to assure that Healthcare Professionals (HCPs) and Healthcare Organizations (HCOs) interactions conform to internal policies, U.S. government agency requirements. • Responsible for oversight and facilitation of the Consultant Activity Planning System (CAPS) for all HCP/HCO interactions end-to-end • Manages training HCP consultants and internal business customers on payment process to ensure compliant interactions and results in CAPS • Implemented process improvements related to HCP/HCO interactions, resulting in automating forms and payment remittance, reduction of turn-around time for contract execution and turn-around time for payments, and cross-divisional alignment for cross-border events • Managed the medical educational grant, sponsorship and charitable donation process within the Request Management System (RMS), resulting in quicker committee review and decreased turn-around time for notification of decisions and payments • Customer Excellence Team Edge Award Winner August 2018 - Consultant Activity Planning System (CAPS) implementation • Founding committee member of the Professional Affairs Committee Summit (PACS) that assures cross-divisional alignment for all Professional Affairs teams for HCP/HCO interactions • Committee member of the Customer Excellence Leadership Awards
• Responsible for oversight and facilitation of all Health Care Provider (HCP) and Health Care Organization (HCO) consulting, clinical trial and master service agreements • Play a key role in assuring Stryker’s overall HCP consulting processes align with internal compliance policies and external federal regulations • Work closely with internal business functions to support key aspects of the HCP consulting relationship resulting in increased cross-collaboration • Manage the HCP payment process as follows: communicate with internal business customers and external HCP consultants; collect, review, verify and submit required documentation and make appropriate changes to ensure a seamless deliverable (consultant payment) is provided • Assist in training HCP consultants and internal business customers on payment process to ensure compliant interactions and results by developing training guides for users • Implement process improvements related to HCP/HCO interactions resulting in automation of payment process, creation of contract request templates to standardize requests and decreased turnaround time for contract execution and payments • Facilitate resolution and corrective action plans related to HCP consulting payments in a timely manner • Partnered with Corporate Informatics Team to implement pilot launch of the Consultant Activity Planning System (CAPS) at NV, resulting in successful transition from previous platform (Corporate Compliance Database) • Recipient of the STAC Employee of the Month Award April 2018
• Primary liaison between department clients for Geriatric Care, Lakeshore, OB/GYN and IVF, Radiation Oncology, Neurosurgery and the central physician billing office Medical Group Business Services (MGBS). • Provided analytic support, problem solving and communication with client departments on all matters pertaining to physician billing resulting in decreased insurance denials and Days in A/R. • Partnered with each CSM in a team environment, where sharing of resources, information, and best practices is encouraged and essential. • Aided UCSF/MGBS in achieving improved results including increased cash collections, reduced accounts receivable, denials management, and reduced bad debt. • Developed and produced reports utilizing data warehouse, APeX (a.k.a. EPIC), and other reporting tools to provide in depth accounts receivable trending and analysis to suggest remediation. • Performed detailed audits to ensure billing efficiency, provided root-cause analysis and remediation to department clients resulting in reduction of denials and increased in cash collections.
• Managed 200+ patient admission/discharge files on a daily basis • Verified insurance information/eligibility and/or obtained HMO Authorizations for potential and current Non-Medicare patients and provided clinical documentation for weekly review to nurse case managers • Decreased total unpaid claims of $1M to less than $100k over a period of 4 months • Responsible for daily and monthly electronic patient census to submit for 3rd party billing • Member of the CQI Committee and Team Leader for Corporate Compliance and Personnel Management to ensure the facility complied with Federal Regulations and documentation to meet California standards and criteria • Gathered documentation needed to process Medicare, Medicaid and HMO claims • Experienced in handling appeals for Medicaid Benefits and new and/or current Medicaid applications • Managed private account balances and collections • Handled Accounts Receivable for the facility on a daily basis • Worked with different departments on projects to improve the quality of service and care provided to the patients and their families at the facility
• Answered and inputted all incoming calls into an electronic database (100+ calls/day) • Managed 20+ plumbing technicians on a day-to-day basis • Assigned and managed open calls to qualified technicians via PTT • Made sure all jobs are completed and fully paid • Followed up on estimates and negotiate pricing to save projects • Followed up and survey on completed calls to up-sell additional estimates • Cold Called 40+ customers per day to sell additional plumbing services • Generated reports for the CFO and CEO • Organized and managed existing account balances for collection
• Provided support for translational research in gene therapy, stem and progenitor cell therapies, pediatric models of human disease, fetal: maternal microchimerism, and in vivo imaging applications • Preserved tissue samples in Formaldehyde • Cleaned and prepared +30 sterile instruments for surgery per day • Assisted with filling of liquid nitrogen storage tanks • Data entry and maintenance of project data electronically and manually • Filed and H&E Stained 60 tissue slides per day • Ran +40 white cell blood counts of various tissues per day • Handled bio-hazardous (chemical and animal tissue) material • Restocked lab inventory weekly • Prepared materials, supplies, and labels for the following week