Jocelyne Shangase Email & Phone Number | Regulatory Document Analyst with extensive expertise in utilizing Adobe Acrobat Pro/ISI Publisher, ISI Toolbox to assemble CMC documents that are governed by cGMP, ICH, and eCDT guidelines for IND/NDA submission. Proficient in formatting Clinical, Quality, Safety and Regulatory documents types in conformance with eCDT practices for electronic submission, ICF guidelines, and cGMP and standard procedures. Document Controller managing document processing within documemtum webtop and desktop, FirstDoc sessions by importing all appendices for clinical study reports, regulatory document components, IND and NDA, sNDA etc. components and ensuring the files are properly nested within their appropriate folders and all properties (metadata) are present as per document types. Report level document publishing (Bookmarking, Hyper-linking, Scanning) Assembling, concatenating of protocol, csr, annual report to a published ready output Compiling word files and pdf files for author reviews Managing workflow for review and approval Providing submission readiness for all document types Electronic Document Management Systems (EDMS/EDMSr) Clinical and non-clinical Document Formatting and Assembly Global Imaging Management Systems Document Quality Standards and Compliance

Jocelyne Shangase

Regulatory Document Analyst with extensive expertise in utilizing Adobe Acrobat Pro/ISI Publisher,...
16 Eckerson Lane, Spring Valley, United States

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Jocelyne Shangase’s Location 16 Eckerson Lane, Spring Valley, United States

Jocelyne Shangase’s Current Industry Abbvie

Jocelyne Shangase’s Prior Industry Pfizer | Novartis | A And M Cosmetics

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Sr. Medical Writing Coordinator/Publisher

2019-12-01 00:00:00 - Present

Document Coordinator IV

2000-01-01 00:00:00 - 2010-12-01 00:00:00

Package Component Lab Assistant

1999-01-01 00:00:00 - 2000-01-01 00:00:00

Lab Assistant (contracted as independent contractor)

1999-01-01 00:00:00 - 1999-01-01 00:00:00

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Jocelyne Shangase is a Regulatory Document Analyst with extensive expertise in utilizing Adobe Acrobat Pro/ISI Publisher, ISI Toolbox to assemble CMC documents that are governed by cGMP, ICH, and eCDT guidelines for IND/NDA submission. Proficient in formatting Clinical, Quality, Safety and Regulatory documents types in conformance with eCDT practices for electronic submission, ICF guidelines, and cGMP and standard procedures. Document Controller managing document processing within documemtum webtop and desktop, FirstDoc sessions by importing all appendices for clinical study reports, regulatory document components, IND and NDA, sNDA etc. components and ensuring the files are properly nested within their appropriate folders and all properties (metadata) are present as per document types. Report level document publishing (Bookmarking, Hyper-linking, Scanning) Assembling, concatenating of protocol, csr, annual report to a published ready output Compiling word files and pdf files for author reviews Managing workflow for review and approval Providing submission readiness for all document types Electronic Document Management Systems (EDMS/EDMSr) Clinical and non-clinical Document Formatting and Assembly Global Imaging Management Systems Document Quality Standards and Compliance