Regulatory Affairs Specialist

Company Profile

McKesson Corporation is a global leader in healthcare supply chain management solutions, retail pharmacy, community oncology and specialty care, and healthcare information solutions. McKesson partners with pharmaceutical manufacturers, providers, pharmacies, governments, and other organizations in healthcare to help provide the right medicines, medical products, and healthcare services to the right patients at the right time, safely and cost-effectively.

United by our I2CARE shared principles, our employees work every day to innovate and deliver opportunities that make our customers and partners more successful - all for the better health of patients. McKesson has been named a "Most Admired Company" in the healthcare wholesaler category by FORTUNE, a "Best Place to Work" by the Human Rights Campaign Foundation, and a top military-friendly company by Military Friendly. For more info, visit www.mckesson.com.

We take pride in our culture of connection and believe in a workplace where everyone can be their full, authentic self. We welcome and encourage veterans, individuals with disabilities and others with diverse perspectives to join our growing team. Your unique perspective and experience are valuable assets that can translate into a rewarding career path with us.

Job Summary

McKesson is seeking a Regulatory Affairs Specialist.

This Specialist will join our team in support of our McKesson Medical-Surgical Business located in Jacksonville, Florida. This role is a hybrid/remote position, working mostly remotely from home, yet with the requirement of going into the Jacksonville office as needed. Given this in-office as needed consideration for the work environment, the candidate location requirement is in the Jacksonville, Florida area.

The Regulatory Affairs Specialist supports the Medical-Surgical business related to the control of Scheduled Drugs. The Regulatory Affairs Specialist will be responsible for ensuring compliance to include adherence to DEA regulations regarding controlled substances, State regulations of controlled substances and prescription drugs, internal due diligence SOP's, and in cross-training in all aspects of the Controlled Substance Monitoring Program Regulatory Compliance Department.

As a Regulatory Affairs Specialist your primary responsibilities include supporting regulatory affairs compliance for current and prospective clients. You will work closely with the regulatory affairs management, department director and/or primary investigators to ensure compliance and prepare for audit activities while meeting strict deadlines.

This Specialist will research State and Federal regulations. This Specialist will assist and provide input in the interpretation of new and changing rules and/or regulations as they relate to customers, products, and vendors. This individual will demonstrate clear and concise communication with team members, while working effectively in teams and building relationships.

Key Responsibilities

• Perform customer due diligence reviews that include assessments of prospective customers and ongoing assessments of current customers.
• Conduct statistical analysis of controlled substance ordering and dispensing data to support due diligence efforts and identify controlled substance trends and anomalies.
• Prepare detail-oriented reports to document due diligence reviews and statistical analyses.
• Engage with sales account managers and other Controlled Substance Monitoring Program (CSMP) team personnel as needed to support program efforts.
• Able to communicate with internal contacts on routine issues.
• You will establish and maintain a document management system for regulatory paper and electronic files.
• You will assist any internal or external audit team with any regulatory related issues.
• Utilize critical thinking skills to resolve issues.
• Ability to research and interpret basic regulations.
• Completes directed assignments.
• Organizes regulatory information to support the regulatory team.
• Maintain regulatory files and tracking databases in Salesforce system.

Critical Skills

• Experience communicating with customers, state, and federal agencies and coordinating with other departments and co-workers to provide excellent customer service.
• Comfortable in an environment that includes a fast pace, high productivity, and minimum supervision.
• High-level analytical and problem-solving skills.
• Organized and detail-oriented.

Additional Knowledge & Skills

• Pharmaceutical or medical experience is a plus.
• Knowledge of relevant Federal and State regulations is preferred.
• Experience conducting due diligence on potential and existing customers.

Minimum Requirements

• 2+ years' experience in a related regulatory field.
• Knowledge of controlled substances is preferred.
• Proficient computer skills, including Microsoft Office (Excel, PowerPoint, Word, Teams) applications.
• Knowledge of Salesforce (CRM) and Smartsheet (Project and work management platform) software is a plus.

Education

• Four-year degree in related field or equivalent experience.

Working Conditions

• Able to travel into the Jacksonville Hub Office, as needed.
• Hybrid/Remote work environment - Work from Home - Jacksonville, FL
• Must be authorized to work in the US unrestricted - This position is not eligible for sponsorship.

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At McKesson, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That's why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves. For more information regarding benefits at McKesson, please click here.

As part of Total Rewards, we are proud to offer a competitive compensation package at McKesson. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

Our Base Pay Range for this position

$22.23 - $37.05

McKesson is an Equal Opportunity/Affirmative Action employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.Qualified applicants will not be disqualified from consideration for employment based upon criminal history.

McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to [email protected] Resumes or CVs submitted to this email box will not be accepted.

Current employees must apply through the internal career site.

Join us at McKesson!
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