Customer Success Manager overseeing client implementations and support in surgical education. Collaborate with hospitals and medical institutions using our online learning platform.
MC
Hybrid Senior Regulatory Affairs Specialist, Controlled Substances Monitoring Program
Posted 2 hours ago
About the role
- Sr. Regulatory Affairs Specialist focusing on compliance and governance under the Controlled Substances Monitoring Program at McKesson. Collaborating across departments for regulatory excellence and optimization.
Responsibilities
- Design and support processes to monitor ongoing compliance with CSMP policies and procedures
- Develop and implement processes to ensure adherence to injunctive relief provisions under the nationwide opioid litigation settlement
- Support engagement with a third-party monitor during annual reviews required by the injunctive relief provisions of the nationwide opioid litigation settlement
- Support CSMP governance activities, including preparing reports and materials for governance-related meetings
- Coordinate cross-functional efforts with internal departments to meet CSMP requirements
- Provide strategic guidance to senior leadership on compliance and governance matters.
Requirements
- Degree or equivalent and typically requires 7+ years of relevant experience
- Minimum 7 years of progressive experience in compliance, regulatory, or legal roles within healthcare or pharmaceutical environments
- Demonstrated knowledge of federal and state regulations governing controlled substances distribution and dispensing
- Exceptional written and verbal communication skills, including experience preparing executive-level reports and presentations
- Proven ability to manage complex projects from inception to implementation, delivering on time and within scope
- Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word) and familiarity with generative AI tools
- Ability to accurately manage and review complex regulatory documentation and compliance processes, ensuring precision and adherence to requirements.
Benefits
- Competitive compensation package
- Annual bonus opportunities
- Long-term incentive opportunities
- Comprehensive health insurance
- Retirement plans
- Flexible working arrangements
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