Phyllis Goodwin-Pearson Email & Phone Number

Florida, United States

Morrisville, NC, US

• The Senior Publishing Specialist is to work in Syneos Health Regulatory Consulting and Submission.
• Performs Assembler tasks within the document publishing system, including, but not limited to,creating publications, modifying outline, assigning and transforming documents, and adding cross references, compliance.
• Performs publishing tasks within the electronic publishing system, including, but not limited to, adding special sheets, applying rules, preparing for publishing, and publishing.
• Performs QC tasks within the electronic publishing system and QC of the published output, including internal QC and QC of client documentation.
• Creates, keys, and assembles client deliverable documents and submissions using standard word processing or publishing systems and utilities (Extedo’s eCTDManager and eSUBmanager, CoreDossier, ISI Toolbox, ISI.
• Takes lead role in preparing full application submission builds.

Morrisville, NC, US

• The Regulatory Publishing Specialist II is to work in Syneos Healths Regulatory Consulting and Submissions. Syneos Health serves as regulatory consultnats to the Pharmaceuticals and medical devices industries. The.
• Perform Assembler tasks within the document publishing system. This includes but is not limited to creating publications, modifying outline, assigning and transforming documents and adding cross references.
• Perform Publishing tasks within the electronic publishing system. This includes but is not limited to adding special sheets, applying rules, preparing for publishing, and publishing.
• Perform QC tasks within the electronic publishing system and QC of the published output.
• May create, key and assemble client deliverable documents and submissions using standard word processing or publishing systems and utilities (InSight Publisher, CoreDossier, ISIToolbox, Acrobat).
• May review documents for legibility, completeness, and accuracy.

Boca Raton, Florida, US

• The ePublishing position evaluates documents received from clinical, QA, manufacturing, and other disciplines for Style Guide and electronic publishing standards (submission readiness), formats documents for submission.
• Imports documents into the EDMS, generates workflows, and ensures completion of workflows to result in submission-ready approved documents.
• Creates and/or processes documents of various types (Word, PDF, Excel, etc) to ensure they are acceptable for use in regulatory submissions.
• Prepares submission ready files for inclusion in eCTD submission, using Adobe and ISIToolbox.
• Performs submissions QC using technical tools such as GlobalSubmit, ISIToolbox, Adobe, etc.
• Performs proofreading, spellchecks, cross-referencing within and across documents, and ensures compliance to standards for text, tables, figures, meta data, styles, etc.

Miami, FL, US

• Healthcare Collections
• Knowledge in the interpretation and application of Managed Care Contracts
• Insurance and Patient Payment Review for proper determination
• Perform various interviewing, fact collection and financial evaluation tasks in connection with credit and collection in a large and diversified hospital serving both non-indigent and indigent patients
• Perform financial counseling with patient from pre-admission through account becoming a discharged zero balance.
• Responsible for interview of patient, family or guarantor to explain charges, hospital policy and payment procedures.

Miami, FL, US

• Publishes electronic regulatory submissions to FDA and other agencies as required, under the general direction of the Manager, Regulatory Operations.
• Ensures submission documents meet technical requirements for electronic submissions; checks format and creates bookmarks and hyperlinks as required.
• Participates in submission teams to advise on optimal submission structure, technical requirements, and submission publishing timelines.
• Assists in preparation of appropriate SOPs and written instructions for regulatory operations procedures.
• Acts as technical expert for electronic document management system; assists others as required.
• Populates electronic document management system with archived paper/electronic documents, as required.

Tel-Aviv, IL

• Use technical expertise for leading e-CTD submission projects
• Create hyperlinks/cross-references/bookmarks
• Troubleshooting document issues with MSWord
• Collaborate with scientific personnel for planning, preparation, publishing and quality control checks of submissions.
• Support submission efforts in other business units.
• Maintain electronic regulatory files and records.

Tel-Aviv, IL

• Use technical expertise for leading e-CTD submission projects
• Creating Hyperlinks/Cross-References/Bookmarks
• Implement all technical aspects for assigned submissions and status updates to concerned parties.
• Troubleshooting document issues with MSWord
• Management of some technical aspects for assigned submissions and status updates to concerned parties
• Collaborations primarily with Regulatory personnel for planning, preparation, publishing, and quality control checks of submissions

• Technical QC of submission documents for electronic submission to the FDA, ensuring compliance with eCTD Standards.
• Experience in Teva’s WISDOM electronic document management system (EDMS based on Documentum), importing, exporting, editing documents in the EDMS, managing workflows (for Edit, Approval, eSignature)
• Bookmarking and Hyper-linking
• Scanning and Typing

• Provides financial support for Regulatory Affairs such as the following:o Reviews, codes and processes invoices along with tracking paymentso Prepares and processes expense reports electronically and ensures.
• Makes all travel and hotel arrangements for department personnel along with processing seminar/conference registrations, when applicable
• Manages payroll for all departmental personnel through the Kronos Time Keeping System
• Supports submission activitieso Scanning and Bookmarking of Regulatory submissions for archiving purposeso Support paper submissions for the FDAo Assisted in preparation of IND & NDA annual reports to submit to FDA.o.
• Other projects, duties and responsibilities as needed and/or assigned

• Provides financial support for Regulatory Affairs such as the following:o Reviews, codes and processes invoices along with tracking paymentso Prepares and processes expense reports electronically and ensures.
• Makes all travel and hotel arrangements for department personnel along with processing seminar/conference registrations, when applicable
• Manages payroll for all departmental personnel through the Kronos Time Keeping System
• Supports submission activitieso Scanning and Bookmarking of Regulatory submissions for archiving purposeso Support paper submissions for the FDAo Assisted in preparation of IND & NDA annual reports to submit to FDA.o.
• Other projects, duties and responsibilities as needed and/or assigned

• Provides financial support for Regulatory Affairs such as the following:o Reviews, codes and processes invoices along with tracking paymentso Prepares and processes expense reports electronically and ensures.
• Makes all travel and hotel arrangements for department personnel along with processing seminar/conference registrations, when applicable
• Manages payroll for all departmental personnel through the Kronos Time Keeping System
• Supports submission activitieso Scanning and Bookmarking of Regulatory submissions for archiving purposeso Support paper submissions for the FDAo Assisted in preparation of IND & NDA annual reports to submit to FDA.o.
• Other projects, duties and responsibilities as needed and/or assigned

Regulatory Affairs Certificate Program

High School