Global Oncology Medical Affairs Governance Lead
211 Mt Airy Rd, BASKNG Basking Ridge, NJ 07920 US
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.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.