Clinical Development Medical Manager overseeing execution and interpretation of clinical trials and data collection activities in China. Leading collaborations with stakeholders to ensure clinical research efficiency.
About the role
- Senior Manager leading quality management activities for Regeneron's clinical trials. Engaging with stakeholders to ensure compliance and support inspection readiness.
Responsibilities
- Acting as a Subject Matter Expert (SME) and key liaison to GDQ to provide support and advise on any quality issues to ensure compliance and for the Quality Risk Assessment process.
- Ensuring and responsible for Risk-Based Quality Management (RBQM) initiatives and process improvements, in partnership with other functional areas.
- Responsible for the management of GCP-compliant activities from a quality perspective in conjunction with the business and the GDQM (GCP) team.
- Providing day-to-day quality and compliance support to cross-functional stakeholders, including issue management (triage/investigation/actions), audit responses, proactive quality management, Corrective Action/Preventive Action (CAPA) oversight, audit/issue trending.
- Engaging with, supporting, and liaising with multiple cross-functional stakeholders whose work impacts the GDQ system.
- Leading Quality Risk Assessment and Control Tracker (QRACT) activities at the time of Protocol development predicated on ICHGCP.
Requirements
- Bachelor's degree with a minimum of 8 years of relevant healthcare/pharmaceutical industry experience
- Experience working in either a quality/compliance role (e.g., Quality Management, Quality Assurance etc.), or in a Clinical Development role with expertise and/or transferable skills related to Good Clinical Practice (GCP), and/or Good Pharmacovigilance Practice (GVP)
- Providing consultation, mentorship, training, and support in respect to compliance with applicable international regulations, practices, and guidelines.
- Advising on the escalation of any quality issues that potentially represent serious non-compliances (or serious breach) via the issue escalation process.
- Supporting the collection and reporting of data (e.g., metrics)
- Contributing to and supporting process improvement initiatives and workgroups, as assigned.
- Exemplifying a quality mindset and behaviors in all interactions with internal and external colleagues, serving as an ambassador for GDQ.
Benefits
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave)
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