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
Job title
Senior Regulatory Affairs Specialist, Controlled Substances Monitoring Program
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