North York, Ontario
Project manager (Pharmaceutical Regulatory Affairs)
Full-time Contract, North York
Leading pharmaceutical company
·To fill the Governance Project Manager (referred to as the Standards PM) role in Regulatory Data Governance group.
We need to continue to maintain the operationalization of Data Governance with subsequent deployment of Vault module for Registration Tracking.
Responsibilities & Deliverables:
· Provide oversight of the GRA Data Governance Requests, ensuring that all requests are recorded in the GRA Request Log, that all information is tracked correctly including assignment to correct Data Steward.
· Drive completion of DG requests through Data Governance processes in compliance with Quality documents. This requires meeting regularly with Data Stewards to review status of the requests that they are working on, prioritizing requests to ensure most urgent ones resolved quickly. This also requires reviewing and monitoring status of requests to ensure they are being addressed and escalating when needed for requests unable to resolve.
· Lead and host all the Data Governance meetings as needed. This includes meetings with Data Owners (CMC & Regulatory-Non CMC), and full Data Governance Core Team meetings. Prepare agendas by coordinating with Data Stewards on DG Requests and other topics ready for review in DG meetings. Send agendas in advance of meetings. Prepare meeting. Ensure minutes and the DG Request Log contains clearly documented DG Decisions.
· Support and continue to develop the Data Governance metrics and KPIs.
Additional information about role to support clarity:
This role is to help lead and drive Data Governance team meetings and activities. Responsibilities include tracking requests, scheduling meetings, planning agendas, leading discussions during meeting, documenting meeting minutes, and tracking decisions and resolution of requests. The tracking of and triage of requests, driving resolution of requests through Data Governance processes and team meeting agendas, and communication of request resolution to requestor. This role occasionally will provide ad hoc QC support for Data Governance Team and deliverables.
Skills: Experience with project management and driving deliverables to completion, experience with Regulatory processes and data, and excellent written and oral communication skills.
Bachelor's Degree in Science (BSc.), Pharmaceutical Regulatory Affairs
4-6 years' experience in project coordination or project management role
Pharmaceutical Regulatory Affairs
Experience with Pharmaceutical Regulatory Data and standards preferred