Sr. Director, Regulatory Affairs at McKesson in Irving, Texas

Job Description:

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care.


What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow's health today, we want to hear from you.


The Senior
Director, Regulatory Affairs will support McKesson's Controlled Substances Monitoring Program (CSMP) by leading a team responsible for conducting customer due diligence, primarily within the Community Pharmacy and Health (CP&H) segment within the Pharmaceutical Solutions & Services (PSaS) business unit. The Senior Director will report directly to McKesson's Vice President, Regulatory Affairs, and provide support by ensuring consistent application of all policies and procedures and completing other assignments as directed. This role will also require providing direction and oversight of CSMP processes, supervision and development of team members, interaction and collaboration with internal and external partners, and decision-making in accordance with CSMP policies and procedures.



Key Responsibilities

• Provide direction, guidance, and oversight of customer due diligence efforts as necessary for
  
  


• compliance with CSMP policies and procedures, applicable laws and regulations governing wholesale distribution of controlled substances, and government settlement agreement terms.
  
  


• Review, edit, and approve due diligence reviews of various types completed by CSMP personnel. The Senior Director may also assist with conducting customer interviews depending on the facts and circumstances of particular due diligence review.
  
  


• Review CSMP reports, analytics, and other data that aid with the identification and direction of customer due diligence workstreams and foster development of customer and geographical trend awareness.
  
  


• Provide team leadership by setting direction and developing team members through coaching, feedback, training, and recognition.
  
  


• Drive performance and productivity of team members and ensure the efficient allocation of workload.
  
  


• Advance continued development of the CSMP through the identification of trends, refinement of policies and procedures, and the development of CSMP-related training.
  
  


• As needed, support the Distribution Regulatory Support (DRS) team and PSaS Distribution Center (DC) personnel during audits by Drug Enforcement Administration (DEA) or other agencies with responsibility for controlled substance-related enforcement.
  
  


• Collaborate with internal stakeholders, including Sales teams (including leadership), Legal, and other members of the Regulatory Affairs team.
  
  

Minimum Requirement



Degree or equivalent experience. Typically requires 13+ years of professional experience and 6+ years of diversified leadership, planning, communication, organization, and people motivation skills (or equivalent experience).



Education



Undergraduate degree or equivalent experience. Advanced degree preferred.



Critical Skills

• 13+ years' progressive experience, preferably in the area of controlled substance compliance, pharmacy practice, and/or diversion or health care law enforcement.
  
  


• Specific knowledge of the Controlled Substances Act (CSA) and equivalent/related state requirements.
  
  


• Experience in regulatory compliance roles, particularly in the area of controlled substance compliance, pharmacy practice, and/or diversion or health care law enforcement.
  
  


• Strong management experience and ability to lead large teams.
  
  


• Excellent communication, presentation, collaboration, and influencing skills at all levels of a highly-matrixed organization.
  
  

Additional Skills

• Ability to exercise professional judgment and propose value-added solutions in all aspects of performance.
  
  


• Ability to prioritize multiple ongoing initiatives and efficiently re-prioritize such responsibilities, as may be required in a changing business environment.
  
  


• Ability to work with sensitive information and maintain confidentiality.
  
  


• Sound judgment and decision-making, which are supportable and appropriate given the available information.
  
  


• Attention to detail, including ensuring verification of work product and conclusions that are well supported and accurate.
  
  


• Effective written and verbal communication skills as demonstrated by the ability to articulate ideas, thoughts, and information in a logical manner and sequence to summarize issues clearly and succinctly.
  
  


• Demonstration of the interpersonal skills necessary to interact collaboratively and productively at all levels of the organization.
  
  


• Strong analytical and organizational skills as well as problem-solving capabilities.
  
  

Travel



Ability to travel domestically up to 15%.


Must be authorized to work in the US. Sponsorship is not available for this position.


We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at McKesson, please click here.



Our Base Pay Range for this position



$153,900 - $256,500



McKesson is an Equal Opportunity Employer



McKesson provides equal employment opportunities to applicants and employees and is committed to a diverse and inclusive environment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age or genetic information. For additional information on McKesson's full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.



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