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Global Oncology Medical Affairs Governance Lead

Basking Ridge, NJ 07920

Posted: 12/06/2022 Employment Type: Contract Job Category: Administrative Job Number: 521683 Is job remote?: No Country: United States

Job Description


Job Description: 

Support Global Oncology Medical Affairs (GOMA) in driving medical compliance standards for business implementation, in close collaboration with cross-functional and regional stakeholders. In this role, there is a potential for scale-up of activities including, but not limited to, other Medical Affairs Therapeutic Areas (e.g., Specialty Medicine), functions (e.g., Quality, etc.) and/or regions (e.g., JP, ASCA).
  • Act as a business subject matter expert and lead for SharePoint / DSeCO educational platforms and repositories including, but not limited to, user access, maintenance, enhancements, requirements, training, and other related platform activities in alignment with organizational needs
  • Responsible for mandatory Learning Management System training assignment and timely functional completion in alignment with Global Quality Assurance standards / requirements
  • Support with establishing, disseminating, and/or maintaining Medical Affairs educational process training, best practices, tool and other relevant information to help impacted functions understand and improve upon ways of working
  • Contribute to the development, execution and/or oversight of an audit and inspection readiness toolkit to help the business strengthen organizational activities and operate at a level that is ready for inspection
  • Support the business to ensure compliance with global processes, applicable laws, regulations, or industry codes.
  • Ensure availability of data analytics, metrics and tools to support monitoring, measurement, or compliance of governance activities
  • Support with developing, maintaining and/or enhancing onboarding process and related activities in partnership with Human Resources and other relevant stakeholders
  • Serve as the responsible person for Records Management procedures, processes and implementation activities for associates based in the United States
  • Support with fostering a collaborative stakeholder experience with a goal for stakeholders from Quality, Compliance, Legal, and other relevant functions, geographies and levels of the organization to feel supported and eager to engage with the governance function
  • Contribute to the execution and/or sustainability of strategic global initiatives including, but not limited to, QA Global SOP Harmonization Initiative (Project REIWA), Oncology Business Unit Work/Life Initiative, R&D Globalization Initiative (Project OCEAN), Learning Counsel, and other relevant initiatives.
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