Jonathan Huynh Email & Phone Number

Mississauga, Ontario, Canada

Oakville, Ontario, Canada

Toronto, Ontario, Canada

- Provide project management support for the EU-REVISE and ICH Q12 projects. Monitor project progress, liaise between project stakeholders, and consolidate documentation for further review by project leads. > EU-REVISE project: support the Sanofi Pasteur and Sanofi teams in their efforts to convince European policymakers to update the European regulatory framework for vaccines for the benefit of public health. > ICH Q12 project: support the implementation of ICH Q12 principles within Sanofi Pasteur by monitoring the implementation progress and liaising between project members to consolidate documentation.- Manage, monitor, and update project action plans to ensure adherence to project deliverable timelines. Liaise between project leads on additional documentation and information requests, and connect with other cross-functional partners to ensure completeness and timeliness of project documentation. - Track project timelines and provide recommendations to the team on priority areas and agenda items, as required. Responsible for sending summary communications and meeting invitations to ensure the team is kept abreast of project progress, and host project team meetings to gather updates from functional areas. - Host and participate in working group sessions and other ad-hoc meetings to resolve and troubleshoot project obstacles and other information gaps. Connect relevant functional areas together to review and complete project deliverables. - ICH Q12: support and author internal documentation advising the manner in which this guideline should be integrated into the existing Sanofi Pasteur framework. Also liaise with and influence the Sanofi team to leverage this guideline through presentations, answering questions, and providing additional metrics. Consolidate and share all relevant documentation. - Draft training materials, internal communications, presentations, and other materials to ensure principles are implemented and fostered across the organization.

Toronto, Ontario, Canada

- Supported the migration of data from the existing ISOtrain training system to the iLearn system.- Liaised with project sponsors, leaders, and teams to complete project activities and ensure best practices are applied in alignment with company and network policies and guidelines.- Provided operational support in projects related to data migration.- Verified and uploaded current effective versions of GXP documents to the LMS database.- Participated in migration tests/cases surrounding the learning management systems.- Collected, sorted, and reported field data gathered during the field migration.

Toronto, Canada Area

- Supported the coordination, compliance, and maintenance of documentation systems, electronic databases, and archiving> Updated, tracked, and monitored electronic databases for accuracy and completion of records.> Supported the update of quality documents and other system documents.> Identified gap/issues with documentation processes/systems and proposed solutions.- Ensured follow-up and accuracy of records, status reporting, and user support across the department.- Documentation issuance and maintenance: fulfilled requests for issuing controlled prints, logbooks, and lab notebooks.- Archiving activities: archival of documents/logbooks/other documents, performed reconciliation activities following Good Documentation Practices and adhered to company guidelines and procedures.

Toronto, Canada Area

- Maintained a variety of databases for AnSci (RTAP sharepoint and project specific sharepoints)> Created and maintained a project deliverables tracking sheet detailing project and department milestones, key dates, stakeholders, and status. Provided updates upon request.- Updated and maintained quality and regulatory documents by incorporating feedback and uploading to the relevant database (GEODE, GDMS, Veeva Vault) for vaccine manufacturing and reference purposes. Ensured accuracy and timely submission.- Assisted in the preparation and compilation of three New Vaccine (NV) project test strategy documents and seven NV specification documents.> Performed regulatory analysis in support of NV projects.> Ensured adherence to relevant regulatory requirements & managed primary review and approval of the submission document.> Ensured regulatory references were up to date and the testing process was compliant with regulatory authorities (FDA, EMA, WHO, ICH).> Reviewed and leveraged past Health Authority feedback and information from related projects and incorporated relevant information into current submission. > Facilitated and directed specification working group meetings with key stakeholders to review and confirm specification test justifications, acceptance criteria, methodology, and other points of clarification. - Supported the team in drafting the chemistry, manufacturing, and controls (CMC) portion of regulatory dossiers throughout clinical trial applications (Phase I to Phase III) for a variety of health authorities.- Supported Global Quality Audit by compiling list of RTAP GMP activities and participated as a runner.- Assisted with Control Record File compilation.- Supported change control process to support the R&D clinical batch release process.

Mississauga, Ontario

- Lead user on pharmacy database (Nexxys) performing data entry/processing and submitting electronic data to the government and insurance companies. Reconcile any issues related to accounts receivable (AR) and prescription payments- Provided front-line support, information, and guidance to patients regarding prescriptions, coverage, regulations, insurance and billing, and refer all medical inquiries to the pharmacist. Also ensure compliance to healthcare legislation and regulations at all times.- Performed pharmacy operations related to drug dispensing, records management, inventory management. Review current drug supply and anticipate future drug needs for patients. - Performed records management to ensure that all documentation is prepared and filed in an orderly and timely manner. Ensure that confidential information is handled appropriately.- Liaised between patients, insurance companies, healthcare professionals, drug companies and distributors regarding drug information and availability, billing, coverage, reversals, and problem solve to ensure positive patient experience and compliance to procedures and regulations.- Progressed into a leadership role and tasked with reviewing work of other technicians, delegating tasks, and entrusted to make decisions regarding dispensary operations.

Ontario College Graduate Certificate, Pharmaceutical Regulatory Affairs And Quality Operations

Honours Bachelor Of Science - Hbsc, Chemistry