Phyllis Goodwin-Pearson Email & Phone Number

Florida, United States

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 checking, Hyper-linking, bookmarking, rendering multiple documents to PDF, creation of external links, completion of Modules 1-5 in eCTD format, compilation of NeeS, compilation of paper submission, publishing and validation. • 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 Publisher, eCTDXpress, eValidator, Acrobat and others). • Takes lead role in preparing full application submission builds. • Troubleshoots issues with eCTD builds and provide guidance to the entry level publishers. • Provides assistance and guidance to entry-level publishers. • Reviews documents for legibility, completeness, and accuracy. • Logs and tracks regulatory documents, publications, and other relevant materials. • Organizes and compiles regulatory documentation, perform pagination, clean-up, and duplication tasks. • May receive and deliver client information/documents, with limited supervision. • Provides alternatives for completing assigned tasks. • Prepares and assembles applications (INDs, NDAs, ANDAs, DMFs, variations, routine reports, renewals etc.) for submission to global regulatory authorities. • Able to prioritize and multi-task a number of projects.

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 Division provides regulatory support to clients of Syneos Health through, preparing, assembling and submitting regulatory applications to various government agencies.• 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.• May log and track regulatory documents, publications and other relevant materials.• May organize and compile regulatory documentation, perform pagination, clean-up and duplication tasks. • May QC materials prepared by team or client.• May receive and deliver client information/documents, with significant supervision.• May provide alternatives for completing assigned tasks.• Prepare and assemble applications (INDs, NDAs, ANDAs, DMFs, etc.) for submission to the FDA.• Experience with electronic publishing of regulatory submissions.• Knowledge of medical/scientific terminology and/or FDA regulations and procedures desirable.• Computer skills including experience with relevant software such as InSight Publisher, Documentum, CoreDossier, Ezsubs, ISI Toolbox, MS Word for Windows, Access.

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 readiness, creates bookmarks, cross-references, and hyperlinks using specialized publishing tools, performs final document quality control, and builds eCTD compliant submissions for INDs, NDAs, and Advertising and Promotion submissions. Responsible for ensuring correspondence and submission documents are properly archived in the electronic document management system (EDMS) environment, the publishing environment, and other electronic environments as assigned. • 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.• As necessary, scans documents and converts format to comply with publishing standards.• Creates forms, templates, and other standardized documents as needed for interdepartmental use.• Maintains paper and electronic file archives for submissions and regulatory correspondence (eg, files and logs), ensures accessibility across departments.• Administrative support for regulatory department as needed.

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. • Responsible for confirming all commercial insurance and conducting extensive third party and welfare program finding to obtain payments as promptly as possible or direct account to collection agency.

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. •Maintains expertise on publishing standards by reviewing agency publications, attending courses and conferences as appropriate, and communicates relevant information to OPKO personnel.

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.• Implement conversion and update activities for scanned paper files and hybrid submissions into full e-CTD submissions.• Perform electronic publishing tasks including assembling submissions electronically, using multiple software’s, with final output on paper and/or electronic media.• May Coordinate with International Counterparts• Management of all technical aspects for assigned submissions and status updates to concerned parties• Maintain expert knowledge of internal and external publishing standards.• Follows Teva Safety, Health, and Environmental policies and procedures. • Other projects and duties as required/assigned

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• Maintaining expert knowledge of internal and external publishing standards• Perform electronic publishing tasks including assembling submissions electronically, using multiple software’s, with final output on paper and/or electronic media.• Follows Teva Safety, Health, and Environmental policies and procedures. • Implement conversion and update activities for scanned paper files and hybrid submissions into full e-CTD submissions.• Support submission efforts in other business units.• Other duties, as assigned, or as business needs require.

• 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 reimbursement has been madeo Manages departmental purchasing of supplies, software and hardware as needed• 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 Assisted in the preparation, compilation, review, copying and distribution of numerous amendments and supplements• 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 reimbursement has been madeo Manages departmental purchasing of supplies, software and hardware as needed• 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 Assisted in the preparation, compilation, review, copying and distribution of numerous amendments and supplements• 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 reimbursement has been madeo Manages departmental purchasing of supplies, software and hardware as needed• 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 Assisted in the preparation, compilation, review, copying and distribution of numerous amendments and supplements• Other projects, duties and responsibilities as needed and/or assigned

Regulatory Affairs Certificate Program

High School