Director of Regulatory Affairs
We are seeking a Director Regulatory Affairs. This role is remote in either IL, IA, MO, IN or WI. Ideal candidate will reside in the greater Chicago IL or Clear Lake, IA area.
This role’s primary responsibility is to support McKesson’s Controlled Substance Monitoring Program (CSMP). The Director of Regulatory Affairs is further responsible for the execution of the CSMP with their geographic region of responsibility by conducting customer due diligence assessments as necessary for compliance to the CSMP. This will require drafting and reviewing investigative reports and analysis, conducting on-site customer visits, customer interaction and interviews and evaluation of findings from these activities. The Director of Regulatory Affairs may also have responsibility for managing one or more direct reports. In addition, this role will support the Senior Directors of Regulatory Affairs by ensuring the distribution centers are in compliance with Federal and State regulations related to the storage, security, reporting requirements, and shipping of controlled substances.
- Conduct customer site visits as necessary for compliance of CSMP. Travel to pharmacy location, review pharmacy procedures and complete internal documentation of visit. Interact with pharmacists and staff to assess their regulatory responsibility
- Review system generated reports and analytics used to identify and report suspicious orders
- Assists distribution centers with responses to governmental inspections and any resulting violations, punitive actions or monetary fines.
- Review documentation surrounding the onboarding of new customers, threshold increases, event triggered activities, as well as various CSMP related situations.
9+ years of professional experience and 1+ years of supervisory and/or management experience
- 5+ years’ experience in a role responsible for regulatory, compliance, operations, or leadership. (Controlled substance compliance experience a plus)
- 1+ years’ experience in a management role
- 5+ years’ experience working in a highly matrixed environment
- Advanced proficiency with MS Office (Word, PowerPoint, Excel)
Additional Knowledge & Skills
- Excellent communication, collaboration and influencing skills at all levels of the organization
- Proficient interviewing and technical writing skills
- Strong analytical skills
- Results Orientation and Energy
- Building Relationships
- Mature Confidence and Integrity
- Assertiveness and Influence
- Controlled substance compliance and diversion enforcement experience
45% travel to multiple U.S. Pharma distribution and customer sites
4-year degree or equivalent experience
- Multi-site warehouse and office environment
- Ability to operate a laptop
- 45% travel to multiple U.S. Pharma distribution and customer sites
Must be authorized to work in the US. Sponsorship is not available for this position.
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 McKessonTalentAquisition@McKesson.com . 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!
Job posted: 2020-09-09