SUMMARY:

• 15 + Years Technical, Process, FDA Submissions, Instructional Writer, IT/Business Operations Analyst, Operational Excellence, Right First Time. Advanced Master Black Belt Lean 6 Sigma, PMP
• Analyze IT and Business processes for process gaps, root cause, Corporate/Government compliance, best business practice, report queries for KPI statistics and continuous process improvements
• Champion Change Management projects through System Development Life Cycle (SDLC), including leading project teams, developing and managing all required project documents (scope, requirements, design, process maps, RACI, interim testing, change orders, etc), budgeting, validation testing/documentation, presenting to executive management, liaison between end - users and IT
• Expert technical writer of Standard Operating Procedures (SOP), Work Instructions (WI), process maps, material (Power Point, Testing, Job Aids), instruction manuals, White Papers, IND/NDA/PMO/FDA submissions, marketing material, Informed Consent, Patient documents, Trainer/Mentor
• Pre - and Post - Implementation process/software audits for gap analysis, compliance and continuous process improvement; author reports on quality and compliance, gap analysis including root cause and remediation recommendations
• Ability to quickly learn new software systems and develop material, user manuals, process maps, WI, SOP, etc. and train/mentor end-users

PROFESSIONAL EXPERIENCE:

Confidential

Technical Writer and Trainer

Responsibilities:

• Collaborated with VPs and cross-functional Subject Matter Experts to develop required SOPs, WIs for application to government program
• Championed development and implementation of SOP and WI templates, material, bench marks, auditing plans, report templates
• Reviewed and edited content of existing SOPs and re-formatted to new SOP template

Confidential

Consultant Medical/Technical Writer

Responsibilities:

• Authored global PMA and IND Invitro and Invivo submissions for medical devices including: informed consent, hypothesis, summary of study, protocol, device description, alternative practices and procedures, marketing history, protocol, methods, facilities, controls, performance standards, technical, results, conclusion, adverse event reports, case report forms
• Reviewed and edited existing US corporate policies and procedure to align with global corporate policies and procedures

Confidential

Senior Business Operations Analyst

Responsibilities:

• Championed the development and successful implementation of Organizational Excellence Change Management Initiative; CMI board included End Users and Subject Matter Experts
• Collaborated with external IT and project team and was assigned to learned new Call Center software: Developed instructional material, including Power Point, Work Instructions and Job Aids, Knowledge Assessment, for Monet Call Center Management System, and trained/mentored Call Center and Pharmacy Operations personnel; monitored for compliance and gaps, conducted root cause analysis and collaborated with IT or management as necessary to develop/implement remediation measures
• Collaborated with Cross Functional team including Pharmacy Solutions, Sales and Marketing and IT to identify business development opportunities
• Championed, implemented and managed call service quality with a focus on customer satisfaction. Average call quality scores increased from 50% prior to implementation of program to 95% within 6 months
• Championed numerous operational database system enhancements, collaborating with internal IT, ScriptMed - Creehan, SME, and end-users to improve operational efficiency and data integrity
• Authored SOPs, Work Instructions, Brochures, Marketing Material, Case Report Forms, Requirement Documents, Validation Reports, Executive Reports (weekly, monthly, quarterly KPI reports),
• Championed development and implemented Materials
• Senior Business Operations Analyst:
• Implemented and maintained the effectiveness of the quality system through the analysis of operational performance, adherence to guidelines and service levels
• Analyzed and compiled key performance and metric data for Pharmacy Solutions operations to evaluate the efficiency and effectiveness of the business units, and reported findings and remediation proposals to Pharmacy Solutions General Manager and GPO Sr. Management
• Applied Lean Six Sigma principals to identify key areas of opportunity in line with business model for improved productivity and synergy
• Identified performance, business and industry trends and transformed into action plans and strategies to meet the short and long term business goals and objectives
• Evaluated current and future processes for optimal efficiency and productivity; Identified efficiency gaps, developed recommendations and implement process improvement initiatives. Monitored and reassessed as needed to assure action plans met operational objectives
• Effectively managed the execution of multiple projects with demanding timelines for successful delivery across internal functional areas, IT and external divisional customers
• Subject Matter Expert (SME) on a workforce management tool to enhance productivity and KPI metric
• Developed and maintained a Master Production Schedule for all functional areas and provided efficient response to business needs, flexing resources and assignments as required. Identified and raised conflicts in schedule to Pharmacy Solutions Senior Management.
• Facilitated implementation of a “Best in Class” business practices and identified opportunities for sustainable improvements
• Monitored post implementation of business software system for referral transmissions from Health Care Provider to Pharmacy Solutions to identify and remediate glitches, collaborated with IT and software vendor to remediate

Confidential

Senior Medical/Technical Writer

Responsibilities:

• Collaborated with cross - functional teams to create new procedures in compliance with Corporate standards, maintain and prioritize projects and timelines; authored Standard Operating Procedures (SOP), Work Instructions, Job Aids, trackers, material, and conducted audits and prepared remediation plans for processes; examples include:
• Internal (Corporate) audit plan
• Cross-functional reconciliation processes to minimize risk of lost/missing documents
• Data retention system in Compound eRoom for managing CIOMS/Expedited Report Packages for CEC submissions, release of CIOMS to sites during study start-up, periodic archival (quarterly) in product file
• Quality Assessment Program for Trial Master File
• Standardized process for outsourcing CDA and contract requests
• FDA Audit plan
• Disaster Recovery Plan
• Trial Master File Audit
• Management of Post Marketing Observational Study
• Using the Investigator Web Response Systems for a Clinical Investigation (Clinphone, Oracle, UBC)
• IMPACT software (collaborated with IT to learn software in order to develop and support documents)
• EDC software (collaborated with IT to learn software in order to develop and support documents)
• CEC Submission of CIOMS and Investigator Brochure Amendments (Chesapeake, Copernicus, IRB Services, Schulman, Sterling, Veritas, WIRB)
• Developed and implemented processes for Managing: Expedited Safety Letters, Essential Documents, IRB Approval of Phase I - IV Clinical Trials and PMOS, Financial Disclosure s (FDC), Clinical Study Report Appendices, Archiving TMF, Essential Document Binders for Phase I - IV and Post Marketing Observational Studies, CMC documents
• Developed and implemented Trackers for: Essential Document, Financial Disclosure, End - of Study Investigator Data Distribution, IVRS/IWRS User Envelope Distribution/Activation/Deactivation, Expedited Safety Letter Ethics Committee Submission and Distribution to Sites during Study Startup, CMC
• Operations:
• Audited current procedures for HIPAA violations, risk exposures, redundancies, efficiency, best practice; develop and implement cost effective processes in compliance with HIPAA, state, federal and company standards; create and implement necessary documents and (e.g. EDC Disc Distribution IVRS. CIOMS)
• Collaborated on interdepartmental projects to identify risk exposures, develop and implement remediation to address the risk, efficiency and quality issues(e.g. CIOMS, EDC MUSL)
• Developed standardized procedure for set-up and maintenance of PI, ED, Site selections, EDC MUSL, EDC End - of Study Data Distribution, PMOS, FDC, Expedited safety Letters, IVRS and CMC with templates and Job Aids
• Developed end-of study reconciliation process for Trial Master File and Essential Documents for Phase I - IV Studies and Post Marketing Observational Studies

Astellas Pharma, Product Safety and Phramacovigilence

Medical/Technical Writer II, Project Manager

Responsibilities:

• Collaborated with international pharmacovigilance team to analyze SAEs, write white papers, created charts and tables for same, develop report content and created Power Point presentation for Astellas executives and FDA
• Authored and co-authored clinical study reports
• Audited Investigator Brochures, Patient information, etc. for compliance
• Audited affiliate contracts
• Authored MAH Agreement, CRO Criteria and Contract, Study Proposals, Standard Operating Procedures, Process Maps, Forms and Templates for Astellas Farma Brazil start-up (in compliance with Brazil regulators Anvisa - National Health Surveillance Agency and MOH - Ministry of Health)
• Authored multiple SOPs, WIs, and Forms in compliance with corporate policies and procedures, and Federal Regulations, and International Regulations, when applicable
• Edited PSURs, CMC documents
• Edited and updated entire Pharmacovigilence library of SOP, WI, and Forms for compliance; created periodic audit schedule
• Collaborated with Japan, Canada and Europe to author global Pharmacovigilance dictionary to maintain corporate compliance
• Project Manager
• Elected to learn new Safety Signal Surveillance database; collaborated; Created process maps for using new software, global SOP, WI, Job Aides, Power Point presentations, all material, and post evaluation tools; collaborated with Japan and Europe to ensure all materials met the requirements for all clients
• Monitored post implementation of software and collaborated with IT to remediate process gaps
• Share Point: Learned new software and created al materials for using new software, including global SOP, WI, job aides and post- evaluation tools
• Collaborated with IT to modify system to requirements of end-users

Confidential

Medical/Technical Writer

Responsibilities:

• Pharmaceutical: Clinical Study Reports, Patient/Subject Consents, Informational Material, CMC documents
• Medical Research: Clinical Study Protocols, NIH Grants, QA Protocols, corporate and regulatory compliance, audit research data, investigational study reports: Manuscripts submitted and published in referred medical journals
• Medical - Legal: Consultant and medical/technical writer to medical malpractice defense attorneys: review medical records to identify of issues that support or refute the malpractice allegations; prepare synopsis of the medical records, deposition transcripts, and other legal documents; prepare summation reports; conduct research to verify Standard of Care, regulatory standards at time of incident and obtain supporting literature; prepare exhibits and other trial material; recommend defense and/or settlement strategies, prepare economic forecasts for future medical expenses for settlement strategy
• Healthcare Industry: Audit medical records, loss runs, incident reports and other data as required to formulate adverse incident reports, trend analysis reports, communicate risk exposures and develop action plans, authored corporate SOPs, procedures manuals, and al materials to support SOPs; Authored/audited contracts for physicians, research sites and principal investigators for clinical trials Authored protocols, grant proposals, budgets, Informed Consents, subject Information documents,, data collection forms, assisted in developing data bases for entering data and running statistical analyses, conducted periodic audits; HIPAA: developed policies and procedures manual and implement, comprehension testing, compliance follow -up of same for physicians and ancillary staff created templates for HIPAA forms for use by hospitals and physician offices
• Risk and Compliance Management
• Analyze loss runs, incident/adverse event reports, and internal processes and procedures to identify trends in areas that potentiate liability risk, quality, compliance and utilization issues; develop SOPs, work instructions and job aids;, implement sessions for upper management and personnel; conduct follow-up audits to ensure compliance and make modifications as necessary
• Championed Total Quality Management. Risk Management and Safety Compliance programs, written manuals and al material for employees Sub Contractors specific to industry needs
• Reviewed staff credentialing process to ensure compliance with JCAHO and other regulatory bodies Develop and implement policies and procedures to promote compliance

Confidential

Senior Risk Manager, Medical/Technical Writer

Responsibilities:

• Risk management consultant to 95 state and Federal physician programs and individual medical group practices across the United States purpose of identifying and modifying risk exposure Generated Adverse Event Analysis Reports, Action and follow - up plans for each group
• Reviewed new medical procedures and technologies (e.g.: laparoscopic surgical procedures, ocular surgical procedures) to analyze financial risk of insuring groups performing new procedures and develop and implement al programs to minimize risk
• Medical/Technical Writer
• Championed development of quarterly publication for clients; lead medical/technical writer and editor for same
• Championed development of al programs for physicians and ancillary staff including publications and job aids
• Championed Healthy Back Program and al material for workers compensation division

Confidential

Medical/Technical Writer

Responsibilities:

• Senior Risk and Compliance Manager for 45 physician accounts and multi-specialty group practices including direct supervision of individuals involved with accounts Generated Adverse Events Reports for each group practice for use in developing risk management and compliance programs
• Supervised development and modification of policies and procedures
• Consulted, developed and implemented credential guidelines for medical professionals, and administrators
• Medical/Technical writer for multiple company publications
• Identified and evaluated liability exposures for clinical procedures, equipment and medications, developed action plans to minimize exposures, and assisted in implementation and follow - up for compliance

Confidential

Responsibilities:

• Developed and implemented adverse event reporting system, collaborated with IT to develop first Adverse Event database
• Conducted routine audits to identify liability exposures as well as inconsistencies in the quality of patient care.
• Authored department-specific and hospital - wide adverse event reports
• Presented in-service to reinforce compliance of policies and procedures and promote quality patient care
• Reviewed policies and modified as necessary to meet standards set by JCHO and other disciplinary bodies
• Investigated adverse events and preserved evidence surrounding the occurrence to determine liability exposures; prepared written analysis to General Counsel
• Developed, implemented and managed adverse occurrence trackers to identify investigate and report potential litigious occurrences to General Counsel; Programs specific to Obstetrics and Gynecology, Anesthesiology, Cardiovascular Surgery, Emergency Medicine and Pathology were developed and successfully implemented
• Developed and initiated hospital wide Total Quality Improvement program: Identified bench marks, monitoring incentives, recording, reviewing and follow - up procedures; moderated kick - off seminar for key physician leaders, administrative staff and ancillary staff
• Liaison: Assisted Legal Counsel as liaison with medical staff and patients on issues including Compliance, Conduct, Consent, Competency, Legal Guardianship, Durable Power of Attorney and Emancipated Minor
• Developed and implemented a subpoena/summons tracker and data base to track legal activity within the Medical Center; acted as liaison between Assistant District Attorneys in Cook, DuPage and Kane Counties to assist in organizing records and testimony in DUI cases

Confidential

Quality Assurance

Responsibilities:

• Quality Assurance Program: Developed and implemented QA program for data collection to monitor trends in patient care Generated Adverse Event and Trend Reports and presented during departmental meetings - potentially litigious occurrences were directly to Risk Management
• Research and Development: Developed research protocols for physicians, residents, and fellows, wrote NIH proposals, and managed clinical trials using oncology and infertility medications, and high risk pregnancies Authored and ghost-authored study reports for publication in refereed medical journals and presentation ant national medical conferences; Developed databases research data collection and statistical analysis, developed Oncology and high risk perinatal databases for tracking treatment protocols of clinical trials and patient follow - up; Developed database for grading medical students’ Obstetrics and Gynecology rotation
• Risk Management: Created benchmark for identification of liability exposures in obstetrical and gynecological patients - this program was adopted by corporate risk Management and served as the prototype for developing programs for other high risk areas