Director, Regulatory Affairs Controlled Substances Monitoring Program (CSMP)

Company: McKesson
Location: Lawrenceville
Posted on: January 26, 2023

Job Description:

Key Responsibilities: Manage Regulatory Affairs CSMP engagement with McKesson suppliers, including manufacturers, regarding controlled substances regulatory compliance, including customer due diligence activities and manufacturer/distributor suspicious order monitoring programs Responsible for ongoing communications with McKesson suppliers relating to controlled substance due diligence and suspicious order monitoring activities Coordinate with Regulatory Affairs CSMP team and other McKesson departments, such as purchasing and supply teams, regarding suppliers' controlled substance inquiries and notifications Serve as Regulatory Affairs resource for knowledge regarding suppliers' controlled substance regulatory compliance program operations Responsible for ensuring that supplier inquiries are handled in accordance with applicable SOPs and coordinating with other CSMP team members to identify and implement ongoing process improvements Support engagement with business stakeholders regarding controlled substance obligations subject to coextensive federal and state regulations Support company and departmental training, including preparation of training materials and coordinating training with company resources Serve as a strategic adviser to Regulatory Affairs senior leadership with regard to federal and state controlled substance regulatory issues Manage team of 1 - 3 direct reports Business Experience - The ideal candidate will possess: Industry-specific knowledge and experience: Prior regulatory compliance experience relating to pharmaceutical manufacturing and/or distribution Direct experience with controlled substance compliance and diversion prevention programs Understanding of controlled substance supply chain operations Extensive knowledge of relevant federal and state regulatory framework for controlled substances distribution and dispensing Professional experience 13 years of professional experience with increasing responsibility and 6 years of diversified leadership, planning, communication, organization, and people motivation skills (or equivalent experience) Proven communication and management skills: Strong communication and presentation skills, written and verbal. Experience with preparing executive-ready written work product and presentations Extensive experience in a complex matrixed organization as an effective team player People management and relationship building skills Experience and comfort communicating with and managing teams working on sensitive and confidential issues Involvement with managing projects across various departments to build consensus towards a common goal Education: Four-year degree in related field Physical Requirements: Office environment 5-10% travel Location: Nationwide 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 $122,600 - $204,300 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 Disability_AccommodationMcKesson.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

Keywords: McKesson, Roswell , Director, Regulatory Affairs Controlled Substances Monitoring Program (CSMP), Executive , Lawrenceville, Georgia