Clinical Study Medical Writer

Therese M De Serto Cohen

Summary:

More than ** 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 maps

Collaborated with Japan, Canada and Europe to author global Pharmacovigilance dictionary to maintain corporate compliance

Author/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 Report

Conduct comprehensive national and international literature searches, MAUDE reports, clinicaltrials.gov searches; retrieve, review and author summaries for pertinent reports

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, CER.

EDUCATION

University of St Francis, Joliet, Illinois, BS Microbiology, BS Biochemistry

Loyola Graduate School of Business, Chicago, Illinois MBA Operations Management, Finance

Advanced Master Black Belt, Lean Six Sigma

Certified Project Management Professional

PROFESSIONAL EXPERIENCE

Baxter Healthcare Corporation

Medical Writer Specialist, Advanced Surgery – Worldwide Medical March 2018 – Present

Author/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 Report

Conduct comprehensive national and international literature searches, MAUDE reports, clinicaltrials.gov searches; retrieve, review and author summaries for pertinent reports

Identify comparator products/devices and develop visual overview of risks and benefits for each comparator product

Develop 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 product

Collaborate on corporate-wide team for process improvement projects

Analyze data warehouse for trending, author clinical reports

Mentor new medical writers: Developed resource materials including product team directories for regular and MDR submissions, authored job aids, product overviews

Independent Consultant: January 2016 – July 2018

Technical/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 documents

Audit 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 selections

Conduct 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 Reports

Joyce Washington, Inc. May 2015 - September 2015

Technical Writer and Trainer for Advocate Physician Partners

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, training material, bench marks, auditing plans, report templates to comply with GCP standards

Reviewed and edited content of existing SOPs, created new format template for corporate-wide use, and re-formatted to new SOP template

Real Staffing

Consultant Medical/Technical Writer March 2015 – May 2015

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, CER

Reviewed and edited existing US corporate policies and procedure to align with global corporate policies and procedures and GMP

Abbvie, Pharmacy Solutions; Senior Business Operations Analyst; Manager Operations Excellence

Manager Operations Excellence: March 2012 – March 2015

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 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 measures

Collaborated 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 analysis

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) in compliance with GCP

Championed development and implemented Training Materials

Audited 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 SOPs

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 in accordance with GCP/GMP

Analyzed 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. 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 in accordance with GCP standards. 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 achievement

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 glitches, collaborated with IT and software vendor to remediate

Abbott Laboratories, GPRD Document Management; Senior Medical/Technical Writer

Senior Medical/Technical Writer April 2010 – January 2012

Collaborated 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 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 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, CER

Developed 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,CER

Developed 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 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 Pharmacovigilance, Medical/Technical Writer II, Project Manager

Medical/Technical Writer: September 2008 – April 2010

Collaborated 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 FDA

Evaluated safety signals and authored data summaries and medical assessments

Authored and co-authored clinical study reports, PSUR, health hazard assessments, CER

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 (GCP/GMP)

Edited and updated entire Pharmacovigilance 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

Collaborated 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 users

Monitored post implementation of software and collaborated with IT to remediate process gaps

Consultant: Quality, Risk and Compliance Management, Medical/Technical Writer

Medical/Technical Writer 1992 – 2009

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 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 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 training 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 educational 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

CNA Companies: Senior Risk Manager, Medical/Technical Writer 1991-1993

Senior Risk Manager

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 educational 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 educational programs for physicians and ancillary staff including publications and job aids

Championed Healthy Back Program and educational material for workers compensation division

MMI 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 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

Loyola Medical Center: Director Risk Management

Total Quality Improvement 1988-1990:

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 education 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

Loyola Medical Center

Quality Assurance and Medical Research Associate 1981-1988

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 directed 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

Past Appointments:

Village of South Barrington, Trustee 2013 – 2018

Create a Change Foundation, Secretary/Treasurer, and Executive Board of Directors 2008 – 20

Ponds Homeowners Association, President 2002 – 2016

Village of South Barrington, Police Commission, Chair Person 2005 – 2013

Awards:

CNA: Employee Initiative Excellence for Development, Implementation, Author and Editor of Medical Publication

Astellas: Star Award for Development and Implementation of Global Pharmacovigilance Adverse Event Software Training Program

Abbott Employee Excellence: Metrix Reporting

Abbvie Employee Excellence: HLink Development and Implementation, Continuous Process Improvement, Root Cause Analysis and Mitigation

Abbvie Pharmacy Solutions: HLink Operations Issues Root Cause Analysis and Mitigation, Champion Change Management Board, Star Employee

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