Compliance Analyst Risk Assessment

Myrah Alvarez

North Providence, RI

Compliance, Data Governance, Risk Assessment Analyst

(REMOTE OPPORTUNITY)

Email: *****.*******@*****.*** Linkedin Profile: linkedin.com/in/myrah-a-85800a125

Mobile: 401-***-****

Professional Summary:

With a decade of expertise as an Ethics Regulatory & Compliance Analyst/Specialist in the Healthcare, Pharmaceutical, and Legal space, possessing a demonstrated proficiency in crafting and executing policies and procedures to guarantee adherence to regulatory standards in diverse Healthcare and Pharmaceutical environments. My adeptness extends to the establishment and supervision of risk assessment initiatives, coupled with a comprehensive skill set in conducting meticulous audits. I boast a robust comprehension of both Federal Regulatory and legal standards, underscoring my commitment to ensuring unwavering compliance within the Compliance landscape.

Education / Training:

Degree: B.S. International Global Business Management/Finance, University of Phoenix

Business Courses: Computer Information Systems, Community College of RI

Remax Realty – Real Estate Course – Mortgage Underwriting

Federal Banking Security Clearance

Core Competencies:

Risk Management

Problem Solving, Integrity

Internal Audit, Customer Service

Analysis, Communication, Ethics

Extensive knowledge of Federal Laws & Regulations, FDA 21CFR, FCAs (Field corrective actions)

General knowledge of database systems such as SAP, TrackWise

Extensive knowledge of sound documentation guidelines and standards for FDA

Crisis Management

Contract Management

Regulatory Compliance, HIPAA, NIST ( National Institute of Standards & Technology

Adaptability, due diligence

Internal Control, Accounting/Collections (CRM tools, ie. Salesforce, Microsoft Dynamics), Credit Bureaus, Root causes Check Banking and Finance

Communication & Project Management

AML (Anti-Money Laundering)

Technical Skills & Software Proficiency:

MS Office Suite (outlook, Excel, PowerPoint, Access & MS Project), SAP, Salesforce, Ariba, PeopleSoft/Oracle Financials, Microsoft Dynamics NAV, EDI, ERP, AS400, B2B, B2C, C2B, C2C, JavaScript/Adobe Suite/Photoshop, IBM OpenPages

Ship Station, Mortgage Underwriting, Equifax, Transunion, Experian, Quality Control, WooCommerce, QuickBooks Online, Tableau, Data Analytics/Analysis, Data Collection, Data Sets, VLOOKUP/XLookup, Pivot Tables. NexSure, RFPs (Purchase orders, contracts)

Proficient in SOP & ISO9001 documentation, ISO27000 Data Security, FDA Regulations, FDA Submissions, CSV/CSA Validations, Discovery Sessions/Clinical Studies, CMS, QA, MedCompli, SpendCatcher, 501C3 Grant writing, Sharepoint, WebEx, Google Docs, Porzio PASID, MedPro Systems- MCR, SAP Concur, CRM/HubSpot, NPPES NPI Federal Registry, HiTrust, Agile Methodologies, cGMP environment, GDPR(General Data Protection Regulation), Compliance Management, Privacy & Risk Management,SOX (Sarbanes-Oxley Act), Qualys (CyberSecurityPlatform), E-Verify, Cyber Compliance, I-9 Compliance, HIPAA, Medicare, Flex Medicaid, Claims processing, Health Insurance Claims, NPPES NPI Federal Registry, cGMP, GDPR, PCI Compliance (Payment Card Industry), CCPA Compliance Environment, Compliance Management,

Reporting for Federal Sunshine Act (HCPs & HCOs), CSV, Veeva CRM, Veeva Network, Veeva Events, Veeva Vault.

Professional Experience:

Otsuka Pharmaceuticals, (Contract), Princeton, NJ / Remote Jun 22 – Jun 23

Governance, Risk & Compliance Analyst

Review regulatory bulletins and other sources of information to research and stay up to date on regulations.

Knowledge of U.S. Federal, Local, and State regulations of protection & patient privacy laws.

Coordinate rate deviation filings and provide overview of product disclosures to compile information.

Supported projects in a dedicated safety database environment with pharmacovigilance (PV) systems projects to ensure compliance within global & local procedures, policies and guidelines.

Establish and enforce organizational standards to maintain quality of service.

Arrange continuing contacts and resolve concerns to maintain rapport with regulatory personnel.

Developed workflow processes to improve documentation accuracy according to FDA rules & regulations

Research both regulatory filing information and writing and communication guidelines to keep other departments aware of requirements.

Prepared documented procedures of the validation life cycle to ensure compliance with FDA regulations, including 21 CFR Part 11

Collect, analyze, and summarize information to prepare informative reports.

Responsible for company Work Practices procedure writing and company policy reviews.

Remain current on the field by attending classes, reading publications, talking with peers, and joining professional groups.

Contribute to team effort through compliance.

Performed clinical documentation improvement activities to ensure accuracy and completeness of HCPs patient studies.

Evaluated internal reviews to ensure all policies and procedures are implemented properly

Managed and submitted CMS Open Payments (Sunshine Act), State and Global reporting requirements to the Federal Government on a monthly, quarterly, and annual basis utilizing aggregate tools (MedPro Spend Suite).

Streamlined Compliance and Transparency across all stages, including spend capture, data remediation, and report submissions.

Collaborated with multiple departments, including Legal, Finance, and R&D.

CITI/Citi Group, (Contract), New York, NY / Remote Aug 22 – Mar 23

Ethics & Regulatory Compliance Risk Analyst/Case Management

Support managing intake received by the Citi Client Ethics hotline using the existing Electronic Case Management System (EOCMS) by routing matters using system workflow functionality and monitoring for follow-up of assignments.

Managed, and validated comprehensive case management services utilizing CSV

Assisted Sr. Management with complaint reviews from customers, internal employees, and issues utilizing the utmost level of confidentiality.

Conduct customer due diligence by analyzing customer profiles, transactions, and other data to identify suspicious activities.

Collaborated with multiple departments, including Compliance, Legal, Finance, and R&D.

Research and verify customer information and transactions following AML compliance regulations.

Develop and implement effective AML processes to reduce risk-related issues.

Conduct regular reviews and assessments of AML systems.

Assist with the preparation of AML-related reports for management and external stakeholders.

Takeda Pharmaceuticals, (Contract), Lexington MA / Remote Jul 21 – Apr 22

Governance, Risk, Regulatory & Compliance Analyst

Review and analyze data submitted in compliance with the Federal Sunshine Act, various State transparency Laws, and Codes of Conduct.

Data collection, validation, and analysis for State and Federal reporting

Maintained awareness of global regulatory reporting obligations and organized workload to ensure compliance with internal and regulatory timelines for adverse events and aggregate reporting

Report data findings and create summaries and year-on-year comparisons for the manager review and approval for data submittal.

Maintained the company’s compliance to FDA regulations particularly 21 CFR Part 11 including requirement specifications and validation protocols.

Ensure data integrity, aggregation, error management, data corrections, monitoring, duplications, and data quality.

Assist with cross-border HCPs HCOs spend internationally and US third party spend.

Reconciliation and remediation for attestation for State and US submittal reports

Coordinate all health care disclosure spending initiatives, including the creation and implementation of the process to ensure compliance with all corporate, federal, and state requirements for tracking and reporting health care expenditures.

Support ad hoc review and research of data submitted in compliance with the Federal Sunshine Act, various State Transparency Laws, and Codes of Conduct as requested by corporations.

Provide support for US reporting as needed during disclosure periods.

Manage the spend matrix of the current state of collection and track progress against the action plan for completion of collection.

Support Project Managers in collecting information from various sources throughout the organization.

Format the data to enable the upload to the transparency reporting tool.

Provide support with all other maintenance required within the US Porzio PASID reporting tool.

Supported ongoing error management, data enrichment, data corrections, monitoring, and data quality checks within the reporting tool.

Assist in the development of data formatting and cleaning criteria from various data sources utilizing Microsoft Excel

Create, review, and update SOPs, guides and support documentation for the department.

United Way, (Contract), Providence, RI/Remote May 21 – Jul 21

Compliance & Regulatory Audit Analyst

Utilized automated tools to extract data from primary and secondary sources.

Provided daily monitoring of data management across the entire organization system.

Developed and maintained databases, data systems- reorganized data in a readable format.

Performed analysis to assess the quality and meaning of data.

Reviewing all relevant programs and activities affected by industry regulations, including records, reports, and software based on Federal Grant approvals.

Monitored data for accuracy and completeness.

Identified relevant information and conducted data entry into Salesforce Migration.

Maintained security and accuracy of confidential data.

Abacus Health Products, Inc., Woonsocket, RI/Remote Mar 19 – Aug 20

Regulatory & Compliance Auditing Analyst

Responsible for monitoring risk management strategies to ensure regulatory compliance with timely and detailed reports.

Assisted Controller and manager of billing compliance in organizing and implementing compliance initiatives related to vendor & customer billing following rules, regulations, laws, and payer contractual requirements.

Researched coding, and coverage. Medical necessity and other compliance issues for all payers related to new charges added to the chargemaster.

Handled heavy direct customer telephone collections of past-due invoices. Coordinated new vendor onboarding and requalification, and supported vendor selection processes through RFI/RFP using Salesforce tools.

Resolved customer problems with their accounts for invoices/billings or cash applications.

Finalized reimbursements based on compliance audit findings.

Analyzing potential risks within the company and its practices to avoid compliance issues.

Compiling reports on the results of external and internal audits and presenting these reports to the relevant supervisors and department heads.

Recording, reviewing, and interpreting data to determine the effectiveness of operations.

Research discrepancies, operational problems, or other issues.

Examining records, reports, receipts, or other documents and comparing them to company assets and liabilities.

Conducted, managed, and oversaw external and internal sample audits. Evaluated suppliers based on their ability to provide goods and services at costs consistent with budgetary expectations.

Prepared financial and market analysis to identify trends and make appropriate recommendations.

Conducted financial statement reviews and developed financial models.

Collaborated with cross-functional teams to develop and implement financial strategies.

Provided support in the development and implementation of budget plans.

W.B. Mason, Brockton, MA/Contract Jan 18 – Jan 19

Credit & Collections Analyst

Analyzed outstanding balances while maintaining good working relationships with customers to resolve collections disputes and resolve any errors.

Managed collection activities on delinquent accounts

Sent statements and dunning letters, initiated telephone contacts for collections of past due accounts.

Monitored payment performances and financial liquidity of existing customers in delinquent status.

Created a "Senior" portfolio of accounts that were deemed more difficult to manage, high profile, large dollar, and high volume.

Developed and prepared daily, weekly, and monthly reports for management on outstanding receivables and collection efforts.

Implemented collections process improvements and participated in PeopleSoft upgrades and improvement projects that dealt with collections.

Maintained accurate coding to the general ledger for all cost components and market and department-level assignments associated with vendor invoices utilizing Oracle.

Reconciling Inter-Company Cash while meeting monthly deadlines.

Verified correct posting of payments to invoices and conducted required audits with vendors to ensure all payments and credits were applied timely and accurately.

Interplex Engineered Products, Rumford, RI Mar 17 – Jan 18

Production Buyer/Planner

Reviewed dispatch list daily, identified reschedules, and alerted master scheduler promptly.

Participated in daily production meetings. Followed up on action items resulting from daily production meetings.

Entered new requirements into the Molding schedule. Material buying for non-customer-supplied parts.

Confirm MRP suggested raw material demand value is in line with actual needs.

Entered POs for zero value toll plated items and outside processing. Work with suppliers to determine delivery dates.

Generated OSP purchase orders, cleanup OSP PO’s monthly and update scrap report. Overaw and tracked work orders, contracts, purchase orders ensuring compliance with terms was met.

Worked closely with internal IEP teams to resolve conflicts regarding production line requirements.

Oversaw key customer accounts and provided communication on order status, net terms, and conditions.

Provided daily and/or frequent customer communication and conducted contract review to include verification of net terms, pricing, lead times, PM Adders, and part revisions, and then entered into PLEX ERP system.

Acknowledged customer orders and update advance ship notice (ASN) capability per purchase order.

Generated and reviewed customer open order report weekly and close out orders with short quantities.

Worked with Customers/Finance to clear invoice holds as required. Handled month-end reconciliation and forecasts raw materials.

Worked with NPI team on new products and processes. Released customer orders daily for shipment.

Participated in cross-functional teams to address customer service issues.

Worked closely with Shipping/Receiving to ensure materials are received and shipped in a timely manner.

Worked with Sales Engineering to better understand Customer requirements and expectations going forward.

Tracked customer orders, planned, forecast, provided updates to Management.

Samsonite International S.A., Mansfield, MA Jun 15 – Jan 16

Collections & Credit Analyst

Reviewed open accounts for collection efforts and conducted outbound collection calls in a professional manner while keeping and improving customer relations.

Resolved client-billing issues and rescued accounts receivable delinquency, applying good customer service in a timely manner.

Collected customer payments in accordance with payment due dates.

Identified issues attributing to account delinquency and discussed them with management.

Reviewed and monitored assigned accounts and all applicable collection reports.

Provided timely follow-up on payment arrangements.

Rhodes Technologies Inc., Coventry, RI Jan 2013 – Dec 2015

Regulatory & Compliance Analyst

Collect, analyze, and process information for the timely completion and filing of compliance information.

Responded to requests from internal and external sources, including State and Federal regulatory authorities.

Monitored pending regulations that may have affected the work of the company and its services.

Communicate requirements of the State and the Federal government to internal and external clients.

Participated in reviews and calibrations to ensure adequacy of policy procedure, and internal controls.

Assisted in maintaining and updating compliance files and spreadsheets according to protocol.

Provided support on report disclosures as needed during heavy reporting periods.

Maintained and regularly updated process documents re: data review.

Applied processes and procedures to support team related to data collection & analysis.

Analyzed and verified test cases and test script functionalities to comply with the 21 CFR Part 11 standards

Provided researchers and formulators in the successful development and launch of new drugs, resulting in FDA approval and an increased market share within the first year of approval.

Wrote & edited clinical documentation according to FDA regulations

Assisted with the pharmacovigilance program, which led to the identification and reporting of any adverse drug reactions which ensured patient safety and compliance with regulatory guidelines during the four stages of the discovery sessions which included (Early drug Discovery, Pre-Clinical Phase, Clinical Phase, and Regulatory Approval)

Worked on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.

Exercised judgment within defined procedures and practices to determine appropriate action.

Support Validation team to develop and implement equipment and automation validation lifecycle processes that incorporate regulatory guidance and compliance expectations.

Support compliance-related tasks such as facility certifications, risk assessment, risk reviews

Compilation of drugs to their indications (usage)

Create, review, and update SOPs, and guides for end user and support documentation.

Additional Experience:

Ehlo Technology, Worcester, MA Feb-2012 – Dec 2019

Compliance & Risk Analyst

Performed all duties/special projects as assigned by Management.

Defined requirements of deliverables before planning how to achieve them.

Scheduled, monitored, and controlled tasks that were required to produce the project deliverables through the use of an infrastructure plan.

Controlled costs of internal resources and reported progress where the cost-to-complete included a risk contingency.

Controlled changes to each project scope (quality), cost, or timing (schedule) concerning the Project Initiation Documentation

Coordinated internal resources and third parties/vendors for the flawless execution of IT projects.

Ensured that all IT projects are delivered on time, within scope, and within budget utilizing Microsoft Project

Maintained all resource availability and project allocation.

Developed project scopes and objectives involving all technical feasibility.

Created and maintained comprehensive project documentation.

Integrated GRC practices into existing IT entities and their policies and procedures to ensure compliance and reduce risk factors

Project Manager

Collected third-party accounts and notified customers about delinquent payments on completed projects.

Scheduled, monitored, and controlled tasks that were required to produce the project deliverables through the use of an infrastructure plan.

Controlled costs of internal resources and reported progress where the cost-to-complete included a risk contingency.

Identified and treated future events that might cause the projects to deviate from the cost plan.

Planned resolution tasks for risks that had been materialized.

Controlled changes to each project scope (quality), cost, or timing (schedule) concerning the Project Initiation Documentation

Coordinated internal resources and third parties/vendors for the flawless execution of IT projects.

Ensured that all IT projects were delivered on time, within scope, and within budget utilizing Microsoft Project

Maintained all resource availability and project allocation.

Developed project scopes and objectives involving all technical feasibility.

Created and maintained comprehensive project documentation.

Served as the main liaison between management, IT engineers, and customers.

Collected third-party accounts and notified customers about delinquent payments on completed projects.

Rockland Financial Mortgage Company, RI 2000 – 2011

Mortgage Consultant/Underwriter

Managed a portfolio of over 200 loan applications, ensuring accurate and timely processing.

Conducted thorough loan analysis and evaluated creditworthiness for mortgage loan applications.

Provided customer one-on-one consultations and advice on loan options and repayment plans.

Developed and maintained relationships with mortgage brokers, lenders and other entities to secure loans.

Negotiated loan terms and successfully closed a variety of loan products.

Prepared and reviewed loan documents for accuracy and completeness under company guidelines.

Assisted customers in navigating the mortgage process from pre-approval to closing.

Analyzed financial data and prepared loan reviews to determine client eligibility.

Investigated loan applications and identified potential risks.

Researched and resolved questions or issues related to loan documents.

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