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Regulatory Affairs Manager – Controlled Substances Monitoring Program
McKesson. Conduct comprehensive customer due diligence assessments for strategic account pharmacies in accordance with Controlled Substances Monitoring Program policies and procedures .
Core Competencies
Role fitUse this summary to align your resume positioning with the role.
Demonstrates expertise in conducting customer due diligence assessments and regulatory compliance within pharmacy operations, utilizing strong analytical skills and effective communication to support informed decision-making. Proficient in managing multiple priorities while collaborating with cross-functional teams to ensure adherence to controlled substance compliance and healthcare regulations.
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Tech Stack
Tools & technologiesAbout the role
Key responsibilities & impact- Conduct comprehensive customer due diligence assessments for strategic account pharmacies in accordance with Controlled Substances Monitoring Program policies and procedures
- Prepare clear, concise written reports documenting due diligence assessments, analysis, findings, and supporting information
- Analyze pharmacy ordering, dispensing, and other relevant customer data to support regulatory compliance and due diligence activities
- Apply data analysis and sound judgment to evaluate information from multiple sources and support informed regulatory decisions
- Collaborate with Sales, Legal, Compliance, Operations, and other internal stakeholders on strategic account customer matters
- Serve as a Regulatory Affairs liaison with corporate compliance teams at national pharmacy organizations
- Manage multiple assessments and competing priorities while meeting established deadlines
- Maintain knowledge of emerging trends related to pharmacy operations, controlled substance compliance, diversion control, pharmaceutical distribution, and healthcare data analytics
- Report to a Director of Regulatory Affairs
- Travel up to 5% annually
Requirements
What you’ll need- Degree or equivalent and typically 4+ years of relevant experience
- Experience analyzing data and information from multiple sources to support business, compliance, regulatory, or risk-based decisions
- Experience preparing written reports, assessments, or similar documentation requiring analysis and attention to detail
- Experience in regulatory affairs, regulatory compliance, controlled substance compliance, healthcare compliance, pharmaceutical distribution, pharmacy operations, or a related field
- Knowledge of controlled substance compliance, diversion control programs, or applicable healthcare regulatory requirements
- Experience conducting customer due diligence, compliance reviews, risk assessments, investigations, audits, or similar analytical reviews
- Understanding of retail, chain, or health system pharmacy operations
- Experience analyzing pharmacy ordering, dispensing, prescription, or other healthcare-related data
- Proficiency with analytical and reporting tools such as Microsoft Excel, Tableau, Power BI, or similar platforms
- Strong written and verbal communication skills, including the ability to communicate complex regulatory or analytical information clearly
- Ability to exercise sound judgment and navigate complex discussions with internal and external stakeholders
- Strong organizational skills with the ability to independently manage multiple priorities and deadlines
- Demonstrated ability to collaborate and influence across cross-functional teams and external partners
- Ability to work independently in a remote environment and collaborate effectively with geographically distributed teams
- Applicants must be currently authorized to work in the United States on a full-time basis without employer support or sponsorship now or in the future
Benefits
Comp & perks- Competitive compensation package
- Annual bonus or long-term incentive opportunities may be offered
- Hybrid work arrangement may be available based on in-office/work-from-home model
- Remote work arrangement
- Reasonable accommodation for job search or application