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Current Need

We are seeking a Regulatory Affairs Manager. This role is located remotely in New Jersey area. If located outside of the area - must be willing to relocate.

This roles primary responsibility is to support the regional Directors of Regulatory Affairs by conducting customer due diligence assessments in accordance with McKessons Controlled Substance Monitoring Program (CSMP). This will require customer interaction and interviews during on-site visits or phone calls; reviewing reports, analyzing and evaluating customers purchase and dispensing data; conducting open source queries; performing State and Federal licensure reviews, and documenting findings from these activities. The role will also include on-boarding reviews and assessments, and customer initiated threshold changes in accordance with CSMP policies and procedures.

Primary Responsibilities

  • Conduct customer site visits as necessary for compliance of McKessons CSMP. This includes travel to pharmacy locations, interacting with customers, conducting interviews, and reviewing pharmacy procedures.
  • Perform customer due diligence reviews that include assessments of prospective customers, customer initiated threshold change requests, event-triggered diligence that incorporates system generated reports and analytics, customer dispensing data, review of State licenses and Federal registration, and open source queries that assist in completing comprehensive customer evaluations.
  • Complete internal documentation of customer visits, due diligence reviews, and assessments of customers regulatory practices and procedures relative to pharmaceutical controlled substances.
  • Review and analyze data to support due diligence efforts and identify/validate controlled substance trends and sourcing profiles to remain current on regional and national diversion trends, related market trends, and regulatory requirements.
  • Seek opportunities to improve CSMP operational excellence through people, processes or technology by frequently engaging with other Regulatory Team members in support of McKessons CSMP.

  • Critical Skills

  • Writing skills - experienced at writing reports, documentation
  • Interviewing and influencing skills
  • Excellent communication skills
  • Analytical - ability to manipulate data within Excel/telling story of data
  • Ability to travel 30%
  • Preferred Skills

  • DEA experience
  • Pharmacy background
  • Controlled substances/diversion knowledge and experience
  • Regulatory Affairs background
  • Physical Requirements

  • 30% Travel
  • Ability to operate a laptop
  • Internal Use Only

  • P3
  • 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 ...@McKesson.com. Resumes or CVs submitted to this email box will not be accepted.Current employees must apply through internal career site.Join us at McKesson!

    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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