Director, Regulatory Affairs Controlled Substances Monitoring Program (CSMP)
Company: McKesson
Location: Lawrenceville
Posted on: January 26, 2023
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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
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