Medical Writing Quality Control
Resume:
Pottstown, PA *****
*****@****.***
www.linkedin.com/pub/jenny-parr/10/a63/b32/
SUMMARY:
Medical writing editor reviewed CMC, nonclinical, clinical, sales and marketing document for submission to regulatory authorities globally
Professional licenses:
Good Clinical Practices
CAREER HIGHLIGHTS:
Insmed:
oSuccessful submission for NDA of amikacin
oReviewed promotional materials in preparation for marketing of amikacin
Elan Drug Technology:
oDeveloped processes for preparation and submission of INDs with a 100% success rate achieved allowing the start of clinical trials
oDeveloped plan for submission of an MAA
Pfizer:
oManaged 256 global clinical studies with timelines for posted on clinicaltrial.gov utilizing Excel spreadsheet
oManaged global teams organizing meetings with clinicians, doctors, medical writers, CROs, and disclosure group for completion of CSRs and posting of clinical results
Merck, Sharp and Dohme:
oDeveloped document project plan for Bayer name change using Merck’s ORB system
oDeveloped strategy for survey answers
oCreated timelines to roll out requested documentation using ORB dashboard and Excel
Taking online Project Planning course from University of Virginia
Had basic Six Sigma training while working at GE
Created efficient processes that saved time and money
PHARMACEUTICAL EXPERIENCE:
Medical Writing Quality Control (medical writing editor)
ProPharma Group, formerly Treximo (October 2019 – May 2023)
Review clinical, nonclinical, CMC, NIH postings, medical device documents.
Help with developing processes.
Mentored and trained new employees.
Subject matter expert in Accenture StartingPoint, and Exedo.
Participated in Lunch and Learn activities.
PTC Therapeutics
Medical Writing Reviewer Consultant (nonclinical editor) July 2019 – September 2019
Reviewed nonclinical documents.
ParrXcellence, Inc. January 2019 – July 2019
Clinical QC Reviewer (medical writing editor)
Reviewed data for submission to ClinicalTrials.gov
Worked on an MAA submission for Module 5
Insmed Inc. May 2017 – January 2019
Clinical QC Reviewer with Real Staffing (medical writing editor)
Developed processes, updated Insmed medical writing style manual, clinical document specific templates, checklists for QC standards.
Perform quality control review of documents (eg, clinical study protocols and amendments, clinical study reports, Investigator's Brochures, and select submission documents) to ensure compliance with the Insmed writing style manual and formatting standards.
Ensure required CSR appendices are compiled and submission-ready before CSR finalization.
QC the reference list in documents, including verifying citation information vs PubMed, ordering copies of references.
QC the list of abbreviations in documents, including verifying that abbreviations are defined at first use in text and used consistently throughout the document per the Insmed Authoring Style Guide, and that all abbreviations used in the document are included in the list of abbreviations.
Format tables according to Insmed standards and QC data in the text against the source tables, figures, and listings.
Proofread documents against the standard template(s) to ensure compliance with required sections and text.
Assist Medical Writing staff with other tasks, as appropriate.
Pfizer Inc., Collegeville, PA October 2016 – December 2016
Clinical QC Reviewer with Aequor Technologies (medical writing editor)
Editorial and data review of clinical documents.
Merck & Co., Inc., North Wales, PA August 2014 – August 2016
Regulatory Operations Specialist with SpectraForce
Worked globally on the Legal Entity Integration project.
Assisted in the end-to-end dossier of manufacturing processes through support and execution of related tasks.
Assisted in the development, planning, implementation and execution of day-to-day operations.
Provided assistance and direct support of the implementation and continual assessment of an optimized submission manufacturing strategy.
Performed duties in a fast- paced environment on the critical path to timely Worldwide Marketing Applications.
Merck & Co., Inc., West Point, PA June 2013 – December 2013
Technical Writer with Hobbie Professional
Remediated GMP quality documentation.
Data auditor for quality standard investigation.
Continuing education courses in scientific areas June 2012 – May 2013
Shire Pharmaceutical, Chesterbrook, PA April 2012 – June 2012
Consultant Regulatory Submissions Manager with BRIO Consulting Group
Worked on migration and clean-up project of MedWatch forms (FDA 3500A) and other safety reports (PSURs, etc.)
Pfizer, Inc., Collegeville, PA November 2010 – April 2012
Consultant for Clinical Writing and Programming with CoreTech Consulting Group (medical writing editor)
Acquired, reconciled final Wyeth legacy reports from affiliate countries as per Pfizer policies with a 99% success rate
Team lead training and facilitating the updates of Wyeth legacy studies in registry system having a high level of reconciliation
Facilitated the writing, reviewing, and posting of basic results to clinicaltrials.gov with a 98% success rate of meeting deadlines
ParrXcellence, Inc., Pottstown, PA January 2010 – March 2010
CMC Regulatory Consultant for Pfizer Inc. (medical writing editor)
Advised on regulatory guidance for CMC submissions for multiple markets for Pfizer
Trained on eCTDxpress
Elan Drug Technology, King of Prussia, PA March 2008 – April 2009
Regulatory Affairs Associate (Consultant) with Astrix Technologies
Advised on regulatory guidance with 100% successful IND submissions
Created eCTD templates for EU, FDA, HC
Published, formatted, edited CMC, MA, IND submissions employing ISI Toolbox
Advised on eCTD submission requirements EU, FDA, HC, MHLW
AstraZeneca Pharmaceuticals LP, Wilmington, DE June 2007 – October 2007
Regulatory Editor (Consultant) with Devon Consulting
Created PDF for compliance submission
Worked on process improvements for improved workflow
Reviewed marketing documentation in Documentum
Annotated in Adobe Acrobat
Merck & Co, Blue Bell, PA March 2007 – May 2007
Validation Documentation Specialist (Consultant) with Devon Consulting
Performed technical administrative duties for Documentum test environment
Performed User Acceptance Testing on migration process
Wrote Migration Plan documentation for Documentum systems
Catalogued all validation documentation
Wyeth Pharmaceuticals, Collegeville, PA December 2006 – February 2007
Documentum Database Specialist (Consultant) with Devon Consulting
Created a Job Aid (work practice) for Regulatory Affairs in the use of workflow for the labeling department utilizing EDMS (Documentum)
Trained labeling team on the use of EDMS
Created folder structures, ACLs, folder properties, importing, exporting documents in EDMS (Documentum)
Wyeth Pharmaceuticals, Frazier, PA October 2006 – December 2006
Technical Writer (Consultant) with MedFocus
Created training aid for the functionality of in-house Lotus database (WATSIN) system for global use
Wyeth Pharmaceuticals, Collegeville, PA December 2005 – October 2006
Document Technologist (Consultant) with MedFocus
Prepared Clinical Study Reports and appendices, Protocols, Investigator Brochures, INDs NDAs, CFRs, and summary documents for submission readiness by utilizing ISI Toolbox and Compose
Subject Matter Expert for Document Processing Guidelines
Assisted directors, writers and document processors with Word problems, and resolved difficult issues under tight deadlines
Created knowledge base for consistent work process flow
Trained on the use of Octagon's Viewpoint workflow processes
Performed quality check for all documents
Knowledgeable on 21 CFR Part 11 guidelines
Centocor, Inc, Malvern, PA May 2005 – December 2005
Validation Document Specialist (Consultant) with Judge Scientific
Performed validation tests for records management software
Edited training materials
Scanned validation documents
AstraZeneca Pharmaceuticals LP, Wilmington, DE January 2004 – May 2005
Medical Communications Specialist (Consultant) with Judge Scientific
Edited documentation for NDA submission document following the AMA writing guidelines
Performed quality review for Clinical Study Reports for in-text tables to match SAS output, figures, house style consistency, and text data
Assisted publishing in scanning documents, checking links in CSR, distilling documents to create FDA submission quality documents
Corrected Word document corruption issues
Reference project: Compiled publications for FDA submission of Module 5.2
Annotated variety of documents for others
Assisted GEL (Documentum) users when problems arose
Helped end users on the use of Word and Excel
Created processes for efficient use of time (one of the processes for adding figures is now being used by 2,000 end users)
EDUCATION:
Trenton State College: Trenton, NJ – BA, Psychology
Mercer County Community College – Majored in Computer Graphics.
PROFESSIONAL DEVELOPMENT:
The Art of the Team Turnaround presented by Daniel Deidl, PhD
Leading With Cultural Intelligence - A Conversation With Dr. David Livermore
Six Sigma Processes
SKILLS:
Both PC and Mac platforms, Advanced Word, Excel skills, PowerPoint, Access, Microsoft Project, Documentum, SharePoint, ISI Toolbox, Box, Six Sigma processes, eCTD, Accenture StartingPoint, Exedo templates, PerfectIT, DocXtools, EndNote, Veeva
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