Michelle Johnson-Saville

Castaic, CA, *****

818-***-****

aceljc@r.postjobfree.com

PROFESSIONAL EXPERIENCE:

December 2013 – To June 2014 Amgen Inc.

GDO Standards Manager III

I supported GDO (Global Development Operations) in the GDO standards documentation life-cycle process, development and revisions of standards documents, maunals, and quick reference guides, and training materials.

I also supported and reinforced compliance and quality culture of complex reports and documents across various functions and internationally.

Responsible for the technical writing of clinical trial SOP's from Study Start-up to Study Close-out

Effectively managed the project development lifecycle of requirements documents and GDO guidance documents and gathered requirements in the planning, testing and implementation phase.

Facilitated, coordinated development, authored, edited, and reviewed standards documents, manuals, and SOP’s that outline GDO processes cross various functions and internationally

Reported on progress and obstacles of assigned projects and enforced project deadlines using MS Project

Assist in the design and building of GDO guidance worksheets, checklists, and associated resource tools

Ensured quality and consistency of GDO guidance documents and uploaded to GDO Central

Worked closely with GDO Standards and Training staff to assure seamless process and interface

Managed high volume of documents at multiple stages of the document lifecycle

May 2010 – May 2013 Global Healthcare Initiatives Corporation

Sr. Project Manager/Compliance/EDI Processes/Clinical Trials

Supervised project leads and business analysts

Lead EDI processes to include the national conversion of electronic data, designing and implementing system processes and maintenance of various business areas throughout various CHC sites using Microsoft Project

Work with Healthcare Organizations on administering benefit plans, training, developing and monitoring productivity and implementation and production of Charitable Healthcare Organizations and members (CHC) sites.

Gathered business and functional requirements, set objectives, created cost benefit analysis for healthcare compliance and quality assurance measures

Monitored process improvement of services and business operations

Point of contact for EDI transactions and processes including qualitative/quantitative analysis

Served as compliance advisor for CHC sites and ensured state, federal, and regulatory standards

Lead communication efforts between users both internal and external

Monitored and analyzed patient data and customer performance

Ensured proper data collection between clinical and administrative staff

Process health insurance claims, appeals, claims recovery, SSD/SSI, Medicare, and Medical

Implemented project improvement strategies for processing insurance claims, and third party recovery

Determined patient eligibility and patient referral authorization

Analyzed and manage current and potential research efforts to bridge gap between healthcare and charitable healthcare organizations through donations for low income families

Analyzed current and potential healthcare risks while creating plans to minimize and eliminate the impacts of disparities within CHC organizations, local hospitals and their practices.

Advised and lead quality assurance efforts to build partnerships with CHC organizations and local hospitals that serve low income families

Provided leadership on guiding statewide CHC organizations to qualify for federal income tax exemption by creating partnerships through hospitals under Section 501(c)(3) because they were engaged in the promotion of healthcare reform

Advised and train CHC organizations on how to use its funds to improve the quality of patient care, expand its facilities, and advance its medical training, education, and research programs.

Lead efforts on health care reform as it relates to CHC by conducting internet and phone research, analysis trends, and using statistical data to support new policies.

Created business plans, project proposals, and financial forecasting to address CHC reform through the use of assessments needs for patient care efforts through various CHG organizations

Managed many research projects totaling 30 million and negotiating new contract budgets

Managed electronic medical records database and EPIC for multiple clinics and projects

Advised CHC organizations on how to implement the provision for their patients through the Affordable Care Act (ACA) for families above 100% and up to 400% of the federal poverty level.

May 2008-May 2010 Global Healthcare Initiatives

Project Manager/Clinical Trials

Managed and provided leadership on collection of CHC data through research for qualifying low income families

Conducted CHC research data analysis and trends using SPSS on community-based needs assessments

Registered medical devices for clinical trials 510(k) class I and class II

Provided leadership on clinical outcomes for test trials

Created business requirements for needs assessment of various statewide CHC organizations

Managed and secured CHC company data for use in trend analysis

Worked closely with executive, technical, management, and medical staff daily

Maintained integrity of patient database & system flow based on trial requirements

Defined scope of work for each CHC test phase by gathering data from CHC contacts

Managed & analyzed risks to the program and maintained quality assurance and followed federal safety and tax regulations

Collected patient data form various sources, screened participants and evaluated their eligibility for acceptance into the study

Collected required forms and signatures and prepared files for review for investigator

Managed internal audits, FDA investigations, and federal compliance & HIPPA regulations

Managed and secured (EMR) electronic medical records database

Conducted training for new personnel

April 2003 – April 2008 Walt Disney Company Glendale, CA

Project Manager/Consultant Consumer Products & Licensing

Managed, developed and created Disney toy brand and licenses

Worked with and communicated with senior executives to develop Disney brand

Supported communications with top Disney executives

Conducted meetings through verbal communication and visual aids

Vocally participated in town hall meetings

Managed and informed team of project deliverables and expectations

Supported change management and quality assurance

Processed award show submittals for SOAPNet, DisneyChannel, and ABC networks

Edited and processed live video submittals for Disney/ABC programming

Processed billing for Disney talent, vendors, and associated clients of Disney cast members

Processed business unit invoices using SAP

Forecasted budget and year end projections for business units

Outsourced vendors for Disney brand television shows and programming

Reported on current initiatives and regulations that impacted the brand and company.

Negotiated contracts and sales profits for Disney production line and content.

Enforced quality control measures according to federal regulations through training and updating manuals and supporting documents.

Managed department budgets and team allocations and company expenditures.

Managed and approved content for production and licensing contracts.

SKILLS:

MS Project, MS Word, MS Excel, MS PowerPoint, Visio, Good ICH/GCP knowledge, Strong understanding of the clinical trial process, Experience in SOP development, Strong project management skills CPR Certification, Healthcare Terminology, EDI Transactions, EFT, Health Insurance Claims, GCP, HIPAA, EMR, EPIC, 510(k) class I & II, MediCal & Medicare, SSD/SSI Program, TV Media Sales and Contracts, TV Traffic and Programming, SDLC Methodology, SAP, Adobe Flash, Blackboard Learning System, Microsoft Office and Crystal Report, SPSS, Apollo travel software, HTML, Internet Browser, ICD-9, ICD-10, CPT Coding, Bilingual (Spanish) and Member of American College of Healthcare Executives Committee.

EDUCATION:

Doctorate/Healthcare Administration TUI University

Masters/Healthcare Management TUI University

Bachelors/Business Admin & Info Technology University of Phoenix

REFERENCES: Furnishes Upon Request

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