Mentor

• Sep 2022 - Present

Principal Managment Consultant

• May 2020 - Present

Management Consultant

• Aug 2018 - May 2020

Senior Regulatory Consultant

• Jun 2017 - Aug 2018

Responsible for creating strategic regulatory process functions for data assessments including content grouping, business rules identification, data assessment requirements, eDMS business requirements, and content harmonization for systems migration. Subject matter expert in the regulatory strategy functions that provides leadership as needed to the regulatory team for data assessment discrepancies and process revision. Created and presented regulatory strategy and business rules to… Show more Responsible for creating strategic regulatory process functions for data assessments including content grouping, business rules identification, data assessment requirements, eDMS business requirements, and content harmonization for systems migration. Subject matter expert in the regulatory strategy functions that provides leadership as needed to the regulatory team for data assessment discrepancies and process revision. Created and presented regulatory strategy and business rules to worldwide project affiliates to ensure a consistent strategic approach in regards to migrating content from a client’s original repository to the new target system. Subject matter expert responsible for providing industry insights and ensuring that best practices are adhered to ensure a smooth transition from one eDMS to another. Documented and analyzed stakeholder feedback, repository needs, migration documentation deliverables, and worked harmoniously with the Project Manager throughout the engagement. Show less Responsible for creating strategic regulatory process functions for data assessments including content grouping, business rules identification, data assessment requirements, eDMS business requirements, and content harmonization for systems migration. Subject matter expert in the regulatory strategy functions that provides leadership as needed to the regulatory team for data assessment discrepancies and process revision. Created and presented regulatory strategy and business rules to… Show more Responsible for creating strategic regulatory process functions for data assessments including content grouping, business rules identification, data assessment requirements, eDMS business requirements, and content harmonization for systems migration. Subject matter expert in the regulatory strategy functions that provides leadership as needed to the regulatory team for data assessment discrepancies and process revision. Created and presented regulatory strategy and business rules to worldwide project affiliates to ensure a consistent strategic approach in regards to migrating content from a client’s original repository to the new target system. Subject matter expert responsible for providing industry insights and ensuring that best practices are adhered to ensure a smooth transition from one eDMS to another. Documented and analyzed stakeholder feedback, repository needs, migration documentation deliverables, and worked harmoniously with the Project Manager throughout the engagement. Show less

Senior Regulatory Consultant

• Aug 2012 - May 2017

Project lead for the development & creation of an innovative Global R&D Cloud based document management technology solution & a ground breaking Clinical Trial Compliance Monitoring digital application. Developed &managed the project plan for the program, led the UI/UX & Development Team to ensure timely & quality delivery of project components. Authored requirements specifications, UAT Scripts, incorporation of industry standards & guidelines. Conducted peer interviews to ensure the solution… Show more Project lead for the development & creation of an innovative Global R&D Cloud based document management technology solution & a ground breaking Clinical Trial Compliance Monitoring digital application. Developed &managed the project plan for the program, led the UI/UX & Development Team to ensure timely & quality delivery of project components. Authored requirements specifications, UAT Scripts, incorporation of industry standards & guidelines. Conducted peer interviews to ensure the solution met holistic needs &developed templates &processes to support the solution. Managed the development & implementation of various Advertising & Promotional standards and created a standardization of FDA eSubmission for Advertising & Promotional Materials. Supported the maintenance &population of a labeling solution for emerging markets & Rest of World. Facilitated in driving optimal market access by ensuring the country affiliates secured rapid regulatory approvals & all labeling is in keeping with product properties & Health Authority requirements. Partnered with local affiliates to create & innovative country specific strategies to regulatory authorities. Supported the development & publishing of time-sensitive submissions for various small Pharmaceutical Companies. The effort included the development of project plan authoring, document acquisition, &submission ready publishing for INDs, NDAs, ANDAs & CTAs. Developed & led the process for the migration of several small Pharmaceutical company's documentation from paper to electronic, with an emphasis on streamlining the archiving & retrieval of information. This included a complete review of all paper documentation, reorganization, classification & migration into online servers. Supported the development & implementation of global eCTD Templates, guidelines & training materials to aid the users in creating & importing documents within electronic data management systems. Show less Project lead for the development & creation of an innovative Global R&D Cloud based document management technology solution & a ground breaking Clinical Trial Compliance Monitoring digital application. Developed &managed the project plan for the program, led the UI/UX & Development Team to ensure timely & quality delivery of project components. Authored requirements specifications, UAT Scripts, incorporation of industry standards & guidelines. Conducted peer interviews to ensure the solution… Show more Project lead for the development & creation of an innovative Global R&D Cloud based document management technology solution & a ground breaking Clinical Trial Compliance Monitoring digital application. Developed &managed the project plan for the program, led the UI/UX & Development Team to ensure timely & quality delivery of project components. Authored requirements specifications, UAT Scripts, incorporation of industry standards & guidelines. Conducted peer interviews to ensure the solution met holistic needs &developed templates &processes to support the solution. Managed the development & implementation of various Advertising & Promotional standards and created a standardization of FDA eSubmission for Advertising & Promotional Materials. Supported the maintenance &population of a labeling solution for emerging markets & Rest of World. Facilitated in driving optimal market access by ensuring the country affiliates secured rapid regulatory approvals & all labeling is in keeping with product properties & Health Authority requirements. Partnered with local affiliates to create & innovative country specific strategies to regulatory authorities. Supported the development & publishing of time-sensitive submissions for various small Pharmaceutical Companies. The effort included the development of project plan authoring, document acquisition, &submission ready publishing for INDs, NDAs, ANDAs & CTAs. Developed & led the process for the migration of several small Pharmaceutical company's documentation from paper to electronic, with an emphasis on streamlining the archiving & retrieval of information. This included a complete review of all paper documentation, reorganization, classification & migration into online servers. Supported the development & implementation of global eCTD Templates, guidelines & training materials to aid the users in creating & importing documents within electronic data management systems. Show less

Dossier Conformance Project Analyst

• Mar 2012 - Sep 2012

Provided expertise and support to the development and implementation of a global CMC dossier repository: • Analyzed historical records of Initial MAA and CMC submissions/approvals for post-market products using multiple platforms (eDMS, change control management system, and legacy CTD eViewer) and with collaboration from local regional strategists. • Formatted pending/approved/current CMC components into eCTD format, and prepared initial repository data load packages in compliance with… Show more Provided expertise and support to the development and implementation of a global CMC dossier repository: • Analyzed historical records of Initial MAA and CMC submissions/approvals for post-market products using multiple platforms (eDMS, change control management system, and legacy CTD eViewer) and with collaboration from local regional strategists. • Formatted pending/approved/current CMC components into eCTD format, and prepared initial repository data load packages in compliance with regulatory standards and technical requirements. Show less Provided expertise and support to the development and implementation of a global CMC dossier repository: • Analyzed historical records of Initial MAA and CMC submissions/approvals for post-market products using multiple platforms (eDMS, change control management system, and legacy CTD eViewer) and with collaboration from local regional strategists. • Formatted pending/approved/current CMC components into eCTD format, and prepared initial repository data load packages in compliance with… Show more Provided expertise and support to the development and implementation of a global CMC dossier repository: • Analyzed historical records of Initial MAA and CMC submissions/approvals for post-market products using multiple platforms (eDMS, change control management system, and legacy CTD eViewer) and with collaboration from local regional strategists. • Formatted pending/approved/current CMC components into eCTD format, and prepared initial repository data load packages in compliance with regulatory standards and technical requirements. Show less

Regulatory Submissions Manager

• Jul 2011 - Mar 2012

• Facilitated the continual improvement and development of the EDMS/RLM database, and implements the new versions into the business. • Owned the integrity of the RLM database, working closely with R&D functions to ensure it becomes the authoritative source of product and market lifecycle information all products. • Tracked global Clinical, Non Clinical Labeling and CMC registration information for use in development of historical summaries. • Managed the creation of data which… Show more • Facilitated the continual improvement and development of the EDMS/RLM database, and implements the new versions into the business. • Owned the integrity of the RLM database, working closely with R&D functions to ensure it becomes the authoritative source of product and market lifecycle information all products. • Tracked global Clinical, Non Clinical Labeling and CMC registration information for use in development of historical summaries. • Managed the creation of data which accurately reflects the lifecycle of global submissions and components, ensuring that approved processes and related SOPs are utilized. Show less • Facilitated the continual improvement and development of the EDMS/RLM database, and implements the new versions into the business. • Owned the integrity of the RLM database, working closely with R&D functions to ensure it becomes the authoritative source of product and market lifecycle information all products. • Tracked global Clinical, Non Clinical Labeling and CMC registration information for use in development of historical summaries. • Managed the creation of data which… Show more • Facilitated the continual improvement and development of the EDMS/RLM database, and implements the new versions into the business. • Owned the integrity of the RLM database, working closely with R&D functions to ensure it becomes the authoritative source of product and market lifecycle information all products. • Tracked global Clinical, Non Clinical Labeling and CMC registration information for use in development of historical summaries. • Managed the creation of data which accurately reflects the lifecycle of global submissions and components, ensuring that approved processes and related SOPs are utilized. Show less

Senior Regulatory Associate

• Sep 2010 - Jul 2011

• Acted as primary point of contact for Digitas Health (DH) brand teams, retrieving information regarding submissions requirements and answering procedural questions that arise during the AstraZeneca Approval Process (AZAP). • Established a timeline and assigns responsibility to the appropriate team members for the delivery of the submission components • Created and oversaw the creation of the components and ensures submissions conform to both AstraZeneca and DH… Show more • Acted as primary point of contact for Digitas Health (DH) brand teams, retrieving information regarding submissions requirements and answering procedural questions that arise during the AstraZeneca Approval Process (AZAP). • Established a timeline and assigns responsibility to the appropriate team members for the delivery of the submission components • Created and oversaw the creation of the components and ensures submissions conform to both AstraZeneca and DH guidelines • Maintained a comprehensive, accurate dashboard of all current and upcoming submissions, including the stage of review, job codes, and deadlines • Created, updated, and disseminated procedures (specific to the brands supported) to the DH Regulatory Review department Show less • Acted as primary point of contact for Digitas Health (DH) brand teams, retrieving information regarding submissions requirements and answering procedural questions that arise during the AstraZeneca Approval Process (AZAP). • Established a timeline and assigns responsibility to the appropriate team members for the delivery of the submission components • Created and oversaw the creation of the components and ensures submissions conform to both AstraZeneca and DH… Show more • Acted as primary point of contact for Digitas Health (DH) brand teams, retrieving information regarding submissions requirements and answering procedural questions that arise during the AstraZeneca Approval Process (AZAP). • Established a timeline and assigns responsibility to the appropriate team members for the delivery of the submission components • Created and oversaw the creation of the components and ensures submissions conform to both AstraZeneca and DH guidelines • Maintained a comprehensive, accurate dashboard of all current and upcoming submissions, including the stage of review, job codes, and deadlines • Created, updated, and disseminated procedures (specific to the brands supported) to the DH Regulatory Review department Show less

Junior Regulatory Submission Specialist

• Nov 2009 - Sep 2010

*Created and customized the roadmap for where the content for the older dossier will be moved to the new dossier *Assisted in the management and assembly of regulatory information for submission *Utilized Pfizer templates for dossier sections, assists in authoring CMC sections for routine submissions (e.g., clinical trial amendments, Type I variations, IND/NDA/BLA annual reports, CMC renewals), including adding technical data and descriptive text *Coordinated with data verification… Show more *Created and customized the roadmap for where the content for the older dossier will be moved to the new dossier *Assisted in the management and assembly of regulatory information for submission *Utilized Pfizer templates for dossier sections, assists in authoring CMC sections for routine submissions (e.g., clinical trial amendments, Type I variations, IND/NDA/BLA annual reports, CMC renewals), including adding technical data and descriptive text *Coordinated with data verification specialist to have the converted document verified for accurate conversion *Managed assembly of regulatory information for submission *Liaised with Senior Submission Preparation resource to have work product reviewed Show less *Created and customized the roadmap for where the content for the older dossier will be moved to the new dossier *Assisted in the management and assembly of regulatory information for submission *Utilized Pfizer templates for dossier sections, assists in authoring CMC sections for routine submissions (e.g., clinical trial amendments, Type I variations, IND/NDA/BLA annual reports, CMC renewals), including adding technical data and descriptive text *Coordinated with data verification… Show more *Created and customized the roadmap for where the content for the older dossier will be moved to the new dossier *Assisted in the management and assembly of regulatory information for submission *Utilized Pfizer templates for dossier sections, assists in authoring CMC sections for routine submissions (e.g., clinical trial amendments, Type I variations, IND/NDA/BLA annual reports, CMC renewals), including adding technical data and descriptive text *Coordinated with data verification specialist to have the converted document verified for accurate conversion *Managed assembly of regulatory information for submission *Liaised with Senior Submission Preparation resource to have work product reviewed Show less

Clinical Trial Document Specialist

• Feb 2009 - Nov 2009

Identified Master Trial Documents and Study Documents submitted to Clinical Documentation and ensure that submitted regulatory documents are in compliance with current SOPs. Entered and attributed all study documentation into Clinical Documentation Indexing and Tracking Systems (CDITS) for tracking and expediting purposes. Imported and distilled electronic file submissions from CDs and inter-departmental Document Organization & Retrieval System (SPDoors). Performed Crystal Report… Show more Identified Master Trial Documents and Study Documents submitted to Clinical Documentation and ensure that submitted regulatory documents are in compliance with current SOPs. Entered and attributed all study documentation into Clinical Documentation Indexing and Tracking Systems (CDITS) for tracking and expediting purposes. Imported and distilled electronic file submissions from CDs and inter-departmental Document Organization & Retrieval System (SPDoors). Performed Crystal Report searches for ad hoc requests concerning study documentation to verify consistency of Master File Reconciliations and CRF Submissions. Show less Identified Master Trial Documents and Study Documents submitted to Clinical Documentation and ensure that submitted regulatory documents are in compliance with current SOPs. Entered and attributed all study documentation into Clinical Documentation Indexing and Tracking Systems (CDITS) for tracking and expediting purposes. Imported and distilled electronic file submissions from CDs and inter-departmental Document Organization & Retrieval System (SPDoors). Performed Crystal Report… Show more Identified Master Trial Documents and Study Documents submitted to Clinical Documentation and ensure that submitted regulatory documents are in compliance with current SOPs. Entered and attributed all study documentation into Clinical Documentation Indexing and Tracking Systems (CDITS) for tracking and expediting purposes. Imported and distilled electronic file submissions from CDs and inter-departmental Document Organization & Retrieval System (SPDoors). Performed Crystal Report searches for ad hoc requests concerning study documentation to verify consistency of Master File Reconciliations and CRF Submissions. Show less

Project Coordinator of Research and Development

• Aug 2008 - Dec 2008

Facilitated internal communications between the research and development, quality assurance, quality control, regulatory, sales and marketing departments. Created presentations, ordered supplies, supported the sales team, processed project sample requests, data entry and filing Closely partnered with the Director of Research & Development on innovative technologies research and to create and implement GMP's and SOP's in order to create a more manageable flow of projects from start to… Show more Facilitated internal communications between the research and development, quality assurance, quality control, regulatory, sales and marketing departments. Created presentations, ordered supplies, supported the sales team, processed project sample requests, data entry and filing Closely partnered with the Director of Research & Development on innovative technologies research and to create and implement GMP's and SOP's in order to create a more manageable flow of projects from start to finish

Formulation Chemist

• May 2008 - Aug 2008

Created bases for lip glosses, lipsticks, foundations, concealers and various skin care products and color matched them to standards Utilized testing results to create CoA's, MSDS and other documentation required for submissions.

Water Treatment Scientist

• Jan 2008 - May 2008

Assisted in operating and maintaining a water treatment facility, performed basic laboratory testing and equipment maintenance, completed required recordkeeping, and maintained an applicable operator certification in order to maintain integrity of service, providing a healthy and clean water supply to customers. Assisted in operating and maintaining a water treatment facility, performed basic laboratory testing and equipment maintenance, completed required recordkeeping, and maintained an applicable operator certification in order to maintain integrity of service, providing a healthy and clean water supply to customers.