Director of Regulatory Affairs
Empowering healthcare starts with you. At McKesson, whether you work in HR or marketing, finance or public affairs, you’re making a difference. You’ll spark a chain reaction that results in millions of people getting more from their healthcare.
As the nation’s leading healthcare services company, we touch virtually every aspect of healthcare. We empower our customers by delivering vital supplies and solutions. And we empower our employees through a supportive environment where opportunity and responsibility grow. Our exceptional leadership team provides the vision and strategy to advance healthcare, so you can feel confident in our direction and your future. At McKesson, we believe we can empower healthcare. And it all starts with you.
Current Need: This role will be responsible for multiple components of Pharmaceutical Solutions and Services (PSaS) Controlled Substance Monitoring Program (CSMP) focused on Retail National Accounts (RNA). The role includes conducting customer due diligence processes as necessary for compliance with McKesson’s CSMP. This role also includes supervisory oversight of manager and associate specialist personnel, partnership with internal RNA teams, external communications with customers and their regulatory or compliance personnel, report writing, and data analysis. The Director will report directly to the Sr. Director in the evaluation of findings from these activities. Duties include:
- Manage activity and direction of Regulatory Affairs personnel.
- Manage the standard CSMP due diligence processes to include customer onboarding, threshold change requests, and various reviews for individual chain registrants.
- Support the Senior Director in chain level due diligence processes.
- Review and analyze chain data regularly to support due diligence efforts and identify/validate controlled substance trends and sourcing profiles.
- Prepare written reports to document reviews and analyses.
- Engage with chain customer regulatory/compliance personnel as needed to support CSMP processes.
- Drive awareness and communication with the RNA Support Solutions and individual Account Managers.
- Seek opportunities to improve CSMP operational excellence through people, processes or technology.
Additional General Responsibilities:
- Provide input and, where required, presentations to internal departments or chain customer audiences.
- Assist other McKesson functions in responding to government or third party inquiries regarding RNA CSMP practices.
Typical Minimum Qualifications
- Degree or equivalent experience.
- Typically requires 9+ years of professional experience and 1+ years of supervisory and/or management experience.
- 7+ of experience and responsibility for regulatory compliance in the pharmaceutical industry.
- A depth of understanding of retail pharmacy operations, controlled substance compliance and diversion programs.
- Analytical, able to communicate and tell a story, with the ability to make strategic, logic-based and educated decisions leveraging data, analysis and information from a variety of sources.
- Excellent communication skills, written and verbal
- Possess interpersonal, people engagement and relationship building skills. Ability to interact at all levels
- Possess working knowledge of Federal and State governmental regulations pertaining to the diversion of controlled substances.
Preferred Knowledge Skills and Experience
- Four-year degree in related field or equivalent experience.
- Up to 10% travel
What’s in it for you:
- Rewarding career with a fortune 7 company that allows you to do great things for patients around the world
- Competitive pay and incentive programs
- Diverse and Inclusive Collaborative environment
- Medical, Dental and Vision Health plans including a great Wellness plan that reduces your premium costs and encourages your best healthy self
- Free biometrics screenings
- Generous PTO and paid Holidays
- 401K with Company Match
- Career development, trainings, tuition reimbursement
- Additional discount programs and more!
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: 2020-07-14