| Candidate Information | | Title | Clinical Study Medical Writer | | Target Location | US-IL-Chicago |
| | 20,000+ Fresh Resumes Monthly | |
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Click here or scroll down to respond to this candidateTherese M De Serto CohenSummary:More than 25 years of experience as a technical/Medical writer, Pharmaceutical Industry: Phase I 4 IND/NDA/PMO/IRB/FDA/WHO submissions, all documents and processes associated with conducting GCP/GMP studies from inception through approval, Post Marketing, 501k, MDR, CER, PSUR, AE, White Paper, cRBA, Corporate Standard Operating Procedures (SOP), Work Instructions (WI), process mapsCollaborated with Japan, Canada and Europe to author global Pharmacovigilance dictionary to maintain corporate complianceAuthor/co-author Regulatory documents for FDA, EU, Foreign Regulatory Agencies submissions for new product, annual or periodic updates, inquiries, including: CER, cRBA, Post Marketing Survey Report, White Paper, Periodic Update Report, Literature Review, Clinical Study Report, New Product Literature Review ReportConduct comprehensive national and international literature searches, MAUDE reports, clinicaltrials.gov searches; retrieve, review and author summaries for pertinent reportsDeveloped and implemented processes for Managing: Expedited Safety Letters, Essential Documents, IRB Approval of Phase I IV Clinical Trials and PMOS, Financial Disclosure Certificates (FDC), Clinical Study Report Appendices, Archiving TMF, Essential Document Binders for Phase I IV and Post Marketing Observational Studies, CMC documents, CER.EDUCATIONUniversity of St Francis, Joliet, Illinois, BS Microbiology, BS BiochemistryLoyola Graduate School of Business, Chicago, Illinois MBA Operations Management, FinanceAdvanced Master Black Belt, Lean Six SigmaCertified Project Management ProfessionalPROFESSIONAL EXPERIENCEBaxter Healthcare CorporationMedical Writer Specialist, Advanced Surgery Worldwide Medical March 2018 PresentAuthor/co-author Regulatory documents for FDA, EU, Foreign Regulatory Agencies submissions for new product, annual or periodic updates, inquiries, including: CER, cRBA, Post Marketing Survey Report, White Paper, Periodic Update Report, Literature Review, Clinical Study Report, New Product Literature Review ReportConduct comprehensive national and international literature searches, MAUDE reports, clinicaltrials.gov searches; retrieve, review and author summaries for pertinent reportsIdentify comparator products/devices and develop visual overview of risks and benefits for each comparator productDevelop competitor product/device library to house clinical study publications that include the competitor and corporate product, competitor IFU, clinical marketing literature, and self-authored summary of risks and benefits of the competitor vs corporate productCollaborate on corporate-wide team for process improvement projectsAnalyze data warehouse for trending, author clinical reportsMentor new medical writers: Developed resource materials including product team directories for regular and MDR submissions, authored job aids, product overviewsIndependent Consultant: January 2016 July 2018Technical/Medical writer (Loyola University)Mentor individuals learning the methodology of completing research documents, technical writing, research findings, SOPs, WIs and other corporate operational documents, and medicolegal documentsAudit data warehouse entries for inconsistencies causing inaccurate reports, scrub data, develop limitations for entries and collaborate with IT and subject matter experts to create drop down lists for limiting data selectionsConduct research on subject matter specific to the assignment (e.g. Standard of Care (GCP/GMP) at the time of an incident, Adverse Events for pharmaceuticals or devices) and prepare narratives, assist with white papers, Adverse Event reports, clinical study reports, investigator brochures, study protocols, citing source documents, post marketing reports, Clinical Evaluation ReportsJoyce Washington, Inc. May 2015 - September 2015Technical Writer and Trainer for Advocate Physician PartnersCollaborated with VPs and cross-functional Subject Matter Experts to develop required SOPs, WIs for application to government programChampioned development and implementation of SOP and WI templates, training material, bench marks, auditing plans, report templates to comply with GCP standardsReviewed and edited content of existing SOPs, created new format template for corporate-wide use, and re-formatted to new SOP templateReal StaffingConsultant Medical/Technical Writer March 2015 May 2015Authored 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, CERReviewed and edited existing US corporate policies and procedure to align with global corporate policies and procedures and GMPAbbvie, Pharmacy Solutions; Senior Business Operations Analyst; Manager Operations ExcellenceManager Operations Excellence: March 2012 March 2015Championed the development and successful implementation of Organizational Excellence Change Management Initiative; CMI board included End Users and Subject Matter ExpertsCollaborated with external IT and project team during development and implementation of new Call Center software: Developed instructional material, including Power Point, Work Instructions, 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 measuresCollaborated with Cross Functional team including Pharmacy Solutions, Sales, Marketing and IT to create data base with user friendly dash board for use by sales force to standardize data input for meaningful queries to identify business development opportunities, gap analysisChampioned, 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 monthsChampioned numerous operational database system enhancements, collaborating with internal IT, ScriptMed Creehan, SME, and end-users to improve operational efficiency and data integrityAuthored SOPs, Work Instructions, Brochures, Marketing Material, Case Report Forms, Requirement Documents, Validation Reports, Executive Reports (weekly, monthly, quarterly KPI reports) in compliance with GCPChampioned development and implemented Training MaterialsAudited data warehouse for discrepancies in data entry and created standardized coding; collaborated with IT to restrict data entry to code; developed training material and trained end users; modified SOPsSenior Business Operations Analyst:Implemented and maintained the effectiveness of the quality system through the analysis of operational performance, adherence to guidelines and service levels in accordance with GCP/GMPAnalyzed and compiled key performance and metric data for Pharmacy Solutions operations to evaluate the efficiency and effectiveness of the business units, reported findings and remediation proposals to Pharmacy Solutions General Manager and GPO Sr. ManagementApplied Lean Six Sigma principals to identify key areas of opportunity in line with business model for improved productivity and synergyIdentified performance, business and industry trends and transformed into action plans and strategies to meet the short and long term business goals and objectivesEvaluated current and future processes for optimal efficiency and productivity; Identified efficiency gaps, developed recommendations and implement process improvement initiatives in accordance with GCP standards. Monitored and reassessed as needed to assure action plans met operational objectivesEffectively managed the execution of multiple projects with demanding timelines for successful delivery across internal functional areas, IT and external divisional customersSubject Matter Expert (SME) on a workforce management tool to enhance productivity and KPI metric achievementDeveloped 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 improvementsMonitored post implementation of business software system for referral transmissions from Health Care Provider to Pharmacy Solutions to identify glitches, collaborated with IT and software vendor to remediateAbbott Laboratories, GPRD Document Management; Senior Medical/Technical WriterSenior Medical/Technical Writer April 2010 January 2012Collaborated with cross functional teams to create new procedures in compliance with Corporate standards and GCP/GMP, maintain and prioritize projects and timelines; authored Standard Operating Procedures (SOP), Work Instructions, Job Aids, trackers, training material, and conducted audits and prepared remediation plans for processes; examples include:Internal (Corporate) audit planCross-functional reconciliation processes to minimize risk of lost/missing documentsData 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 fileQuality Assessment Program for Trial Master FileStandardized process for outsourcing CDA and contract requestsFDA Audit planDisaster Recovery PlanTrial Master File AuditManagement of Post Marketing Observational StudyUsing the Investigator Web Response Systems for a Clinical Investigation (Clinphone, Oracle, UBC)IMPACT software (collaborated with IT to learn software in order to develop training and support documents)EDC software (collaborated with IT to learn software in order to develop training 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 Certificates (FDC), Clinical Study Report Appendices, Archiving TMF, Essential Document Binders for Phase I IV and Post Marketing Observational Studies, CMC documents, CERDeveloped and implemented Trackers for: Essential Document, Financial Disclosure Certificate, 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,CERDeveloped and implemented processes for CRO business, SOPs, WI, processes specific to the stud and in accordance to corporate and GCP/CMP standards. Conducted frequent audits to identify/remediate gaps and quality issues in data.Operations:Audited current procedures for HIPAA violations, risk exposures, redundancies, efficiency, GCP/GMP; develop and implement cost effective processes in compliance with HIPAA, state, federal and company standards; create and implement necessary documents and training (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 AidsDeveloped end-of study reconciliation process for Trial Master File and Essential Documents for Phase I IV Studies and Post Marketing Observational StudiesAstellas Pharma, Product Safety and Pharmacovigilance, Medical/Technical Writer II, Project ManagerMedical/Technical Writer: September 2008 April 2010Collaborated with international pharmacovigilance team to analyze SAEs, write white papers, CER, created charts and tables for same, develop report content and created Power Point presentation for Astellas executives and FDAEvaluated safety signals and authored data summaries and medical assessmentsAuthored and co-authored clinical study reports, PSUR, health hazard assessments, CERAudited Investigator Brochures, Patient information, etc. for complianceAudited affiliate contractsAuthored 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 (GCP/GMP)Edited and updated entire Pharmacovigilance library of SOP, WI, and Forms for compliance; created periodic audit scheduleCollaborated with Japan, Canada and Europe to author global Pharmacovigilance dictionary to maintain corporate complianceProject ManagerCollaborated with software vender during development of Safety Signal Surveillance database; championed development and implementation of standard queries, process maps, global SOP, WI, Job Aides, Power Point presentations, training material, post training evaluation tools; collaborated with Japan and Europe to ensure all materials met the requirements for all end usersMonitored post implementation of software and collaborated with IT to remediate process gapsConsultant: Quality, Risk and Compliance Management, Medical/Technical WriterMedical/Technical Writer 1992 2009Pharmaceutical: Clinical Study Reports, Patient/Subject Consents, Informational Material, CMC documentsMedical 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 journalsMedical 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 strategyHealthcare 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 educational 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 training, comprehension testing, compliance follow -up of same for physicians and ancillary staff created templates for HIPAA forms for use by hospitals and physician officesRisk and Compliance ManagementAnalyze 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 training sessions for upper management and personnel; conduct follow-up audits to ensure compliance and make modifications as necessaryChampioned Total Quality Management. Risk Management and Safety Compliance programs, written manuals and educational material for employees Sub Contractors specific to industry needsReviewed staff credentialing process to ensure compliance with JCAHO and other regulatory bodies Develop and implement policies and procedures to promote complianceCNA Companies: Senior Risk Manager, Medical/Technical Writer 1991-1993Senior Risk ManagerRisk 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 groupReviewed 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 educational programs to minimize riskMedical/Technical WriterChampioned development of quarterly publication for clients; lead medical/technical writer and editor for sameChampioned development of educational programs for physicians and ancillary staff including publications and job aidsChampioned Healthy Back Program and educational material for workers compensation divisionMMI Companies: Senior Risk and Compliance Manager for Physician Services,Medical/Technical Writer 1990-1991: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 programsSupervised development and modification of policies and proceduresConsulted, developed and implemented credential guidelines for medical professionals, and administratorsMedical/Technical writer for multiple company publicationsIdentified and evaluated liability exposures for clinical procedures, equipment and medications, developed action plans to minimize exposures, and assisted in implementation and follow up for complianceLoyola Medical Center: Director Risk ManagementTotal Quality Improvement 1988-1990:Developed and implemented adverse event reporting system, collaborated with IT to develop first Adverse Event databaseConducted routine audits to identify liability exposures as well as inconsistencies in the quality of patient care.Authored department-specific and hospital wide adverse event reportsPresented in-service education to reinforce compliance of policies and procedures and promote quality patient careReviewed policies and modified as necessary to meet standards set by JCHO and other disciplinary bodiesInvestigated adverse events and preserved evidence surrounding the occurrence to determine liability exposures; prepared written analysis to General CounselDeveloped, 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 implementedDeveloped 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 staffLiaison: 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 MinorDeveloped 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 casesLoyola Medical CenterQuality Assurance and Medical Research Associate 1981-1988Quality 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 directed to Risk ManagementResearch 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 rotationRisk 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 areasPast Appointments:Village of South Barrington, Trustee 2013 2018Create a Change Foundation, Secretary/Treasurer, and Executive Board of Directors 2008 20Ponds Homeowners Association, President 2002 2016Village of South Barrington, Police Commission, Chair Person 2005 2013Awards:CNA: Employee Initiative Excellence for Development, Implementation, Author and Editor of Medical PublicationAstellas: Star Award for Development and Implementation of Global Pharmacovigilance Adverse Event Software Training ProgramAbbott Employee Excellence: Metrix ReportingAbbvie Employee Excellence: HLink Development and Implementation, Continuous Process Improvement, Root Cause Analysis and MitigationAbbvie Pharmacy Solutions: HLink Operations Issues Root Cause Analysis and Mitigation, Champion Change Management Board, Star Employee |
