Regional Clinical Compliance Senior Director
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Job Description
Senior Director overseeing Global Clinical Compliance and Inspection Management strategies for BeOne Medicines. Implementing best practices and supporting compliance readiness across clinical operations globally.
Responsibilities:
- Responsible for implementing Global Clinical Compliance and Inspection Management strategy across BeOne Medicines Clinical activities at global, regional, country, site and/or study levels
- Provides compliance oversight as well as quality support to BeOne GCO study teams
- Seeks opportunities to implement best practices and drive improvements
- Supports timely identification of non-compliance issues and quality events
- Tracks and trends non-compliance issues and quality events
- Supports Global and Regional Clinical Compliance in the development of GCP readiness activities and programs
- Provides guidance and oversees GCP expertise to stakeholders
- Responsible for GCP compliance guidance and support across a portfolio of studies
- Engages in career development planning for direct reports
Requirements:
- Bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical or healthcare discipline
- Minimum of 12 years of progressive experience in clinical operations roles
- Minimum 12 years’ experience in a GCP compliance or equivalent role (i.e. quality) is preferred
- Experience in oncology global trials is preferred
- Excellent English written and verbal communication and interpersonal skills
- Strong analytical and managerial skills
- PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
Benefits:
- Health insurance
- 401(k)
- Flexible working arrangements
- Professional development opportunities
- Paid time off
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