John MacRae

Experience

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  Health Canada | Santé Canada

  May 2016 - now

  Supervisor of the the Submissions Processing Unit in the Office of Submissions and Intellectual Property. Supervisory duties revolve around the administrative processing of drug submissions intended to be reviewed by the Pharmaceutical Drugs Directorate, Biological and Radiopharmaceutical Drugs Directorate, Natural and Non-prescription Health Products Directorate, and/or the Marketed Health Products Directorate. This includes updating current processes and implementing new procedures that are to be performed by the unit.In addition to supervising a team of 8, I am also responsible for routine communication with internal and external stakeholders regarding processing procedures, urgent submissions, and remediating any errors or discrepancies in what is being provided. This involves interpreting and applying the Food and Drugs Act, Guidance Document: The Management of Drug Submissions and Applications, and other regulations and Guidances concerning drug submissions in Canada. Show less Supervisor of the the Submissions Processing Unit in the Office of Submissions and Intellectual Property. Supervisory duties revolve around the administrative processing of drug submissions intended to be reviewed by the Therapeutic Products Directorate, Biological and Radiopharmaceutical Drugs Directorate, Natural and Non-prescription Health Products Directorate, and/or the Marketed Health Products Directorate. This includes updating current processes and implementing new procedures that are to be performed by the unit.In addition to supervising a team of 14, I am also responsible for routine communication with internal and external stakeholders regarding processing procedures, urgent submissions (such as treatments and vaccines provided under the purview of the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19), as well as remediating any errors or discrepancies in what is being provided. This involves interpreting and applying the Food and Drugs Act, Guidance Document: The Management of Drug Submissions and Applications, and other policies/Guidances concerning drug submissions within Health Canada. Show less Acting employment within the Regulatory Affairs Division of the Office of Submissions and Intellectual Property.Current duties revolve around aiding management in maintaining office-wide deadlines, communications with both internal and external stakeholders regarding drug submissions and their contents, compiling statistics regarding drug submissions, and making decisions regarding operating procedures and updating them accordingly. I am also responsible for overseeing the classification process of drug submissions received by Health Canada and the uploading of Notices of Compliance (NOCs) to the NOC Database.In addition to my main duties, I have also aided management in updating procedures as they pertain to the COVID-19 pandemic and have also aided the Submissions Processing Unit in identifying and processing submissions that fall under its scope. Show less Assignment within the Website Publications Unit in the Office of Submissions and Intellectual Property.Duties revolved around the proofreading, editing, and formatting of documents that were intended to be posted on the Health Canada website. Content was managed to be in compliance with the Treasury Board of Canada Secretariat's Content Style Guide when appropriate. Postings that were deemed scientific and technical in nature were formatted to maintain proper scientific notation and content (for example, content intended for healthcare professionals or the drug industry); Otherwise, content was formatted to be legible by the Canadian public. The process of editing documents was a collaborative effort between myself, the client (i.e. technical writers, policy analysts, etc.) and the publisher (i.e. developers and coding experts). Show less Employment within the Regulatory Affairs Division of the Office of Submissions and Intellectual Property. Duties primarily revolved around the administrative processing of drug submission applications and transactions. This entailed a thorough understanding of the drug submission life cycle and groups/persons certain activities are required to go to. In cases where errors were made administratively, I was required to contact agents of health product companies to seek clarification and possible re-submission. I was also required on a rotating basis to monitor the unit's inbox to respond to inquiries as well as complete tasks including but not limited to: creating restricted access for external reviewers, expedite transactions, and provide updates on the progress of a drug submission. Show less My duties involved the screening of Administrative Notifiable Changes, in which I ensured that licensing agreements between products are valid and that no changes or updates are provided in labelling and other materials that violate Health Canada's Administrative Guidance. In addition, I prepared packages for Notices of Compliance as well as No Objection Letters that are issued to products reviewed administratively. Other duties included the processing of drug submissions and transactions involving submission classification, structure and technical verification, and direct contact with regulatory agents of drug companies. Internal responsibilities include maintaining Health Canada's tracking systems and ensuring target dates are met, as well as passing submissions and transactions to reviewers after they are deemed administratively complete. I have also organized and revised Standard Operating Procedures pertaining to submissions processing as the Therapeutic Products Directorate further commits to paperless drug submissions. Show less

  • Senior Program Officer (Supervisor)

    Dec 2022 - now

  • Project Analyst

    Jun 2022 - Dec 2022

  • Senior Program Officer (Supervisor)

    Nov 2020 - Sept 2022

  • Senior Regulatory Affairs Officer

    Mar 2020 - Nov 2020

  • Website Publications

    Oct 2019 - Mar 2020

  • Program Support

    Apr 2019 - Oct 2019

  • FSWEP Student

    May 2016 - Mar 2019
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  Ontario New Democratic Party

  Nov 2021 - Dec 2021

  Nomination Candidate

  Sought nomination for the Ontario New Democratic Party in the riding of Lanark-Frontenac-Kingston. Outreach to members in the riding on policy positions and priorities, including social media marketing. While not nominated, won ~45% of the nomination vote.