John Mathieson Email & Phone Number

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• The QC review of Common Technical Document (CTD) summaries against source data to ensure the information is factual, consistent and editorially correct.
• Provide Regulatory guidance to project teams and/or clients as appropriate
• Preparation and support in the preparation of all submission types in adherence with applicable legislation, regulations and guidelines facilitating approvals and continued client compliance (BLA, IND, NDA, OPDP, SPL.
• Monitoring and managing project-specific email accounts, box accounts, share point sites, incoming faxes and telephone calls.
• Maintains a positive and productive liaison with internal and external contacts. This includes being the primary liaison with the FDA and clients.
• Attends formal interactions (face-to-face meetings, telecon's etc.) with clients, and FDA. Builds positive working relationships with clients.

Dundas, Ontario

• Monitor phone, fax and e-mails and correspond with customer or client as per client’s and OptumInsight’s Standard Operating Procedures.
• Review and submit Individual Case Safety Reports (ICSRs) to health authorities as per client agreements. This includes preparation of cover letter and other necessary documents.
• Enter source information for ICSRs to safety database/product safety logs ensuring accurate data entry
• Reconciliation of safety data as per client agreements.
• Editorial review of pharmacovigilance reports (PSURs, ASR etc.)
• MedDRA coding upon request.

Mississauga, Ontario

- Summer seasonal position- Provided excellent on the job customer service and communication skills- Responsible for delivery truck safety and proper maintenance- Demonstrated strong safety skills while in the warehouse and operating the delivery truck

Milton, Ontario

- Part-time employment in between school semesters- Demonstrated excellent customer service and safety skills in the working environment- Organized building workshops for both adults and children- Demonstrated strong computer skills for building customer order quotes, and creating deck designs

Cambridge, Ontario

- Development of strong presentation skills- Demonstrated excellent attention to detail when completing and reviewing legal insurance documents- Responsible for giving strategic insurance advice

Regulatory Affairs Postgraduate Program, Regulatory Affairs

Masters Of Science In Education, Adolescent Education In Science

Bachelor Of Science, Biomedical Sciences, Minor In Biology