Director of Regulatory Affairs

MedStar Health; Town of Texas (WI); Remote; USD 100,000 - 168,000; Full time

Job summary

MedStar Health is seeking a Director of Regulatory Affairs to oversee compliance and regulatory processes within their distribution centers. The successful candidate will lead due diligence reviews and conduct statistical analyses of controlled substances, ensuring high-quality service. A minimum of 9 years in regulatory compliance is required, alongside strong leadership capabilities and proficiency in data analysis and communication.

Qualifications

• 9+ years of relevant experience in regulatory compliance.
• Able to lead and manage a team for high-quality work.
• Strong verbal and written communication skills.

Responsibilities

• Manage due diligence reviews and regulatory assessments.
• Conduct data analysis on controlled substance usage.
• Support the Senior Director in various regulatory functions.

Skills

Regulatory compliance

Leadership

Data analysis

Interpersonal skills

Communication

Education

Four-year degree in a related field

Tools

Microsoft Office

Salesforce

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.

McKesson's Controlled Substances Monitoring Program (CSMP) is seeking a Director of Regulatory Affairs (DRA) to join our team in support of our Conroe and Memphis Distribution Centers. This role is a work-from-home position with a candidate location requirement of Texas, Tennessee, Arkansas, Alabama, or Louisiana.

This position plays a critical role supporting the regional Senior Director of Regulatory Affairs through leadership and management of due diligence assessments and controlled substance data analysis for our non-chain pharmacy customers.

Key Responsibilities

• Effectively lead and manage direct reports and their due diligence review workloads.

• Perform customer due diligence reviews that include assessments of prospective customers and ongoing assessments of current customers.

• Interview pharmacists-in-charge, pharmacy ownership, and other staff as needed.

• Conduct pharmacy site visits as needed in support of customer due diligence reviews.

• Conduct statistical analysis of controlled substance ordering and dispensing data to support due diligence efforts and identify controlled substance trends and anomalies.

• Prepare detail-oriented reports to document due diligence reviews and statistical analyses.

• Engage with sales account managers and leadership, and other CSMP team personnel as needed to support program efforts.

Minimum Requirement

Degree or equivalent experience. Typically requires 9+ years of professional experience and 1+ years of supervisory and/or management experience.

Education

Four-year degree in a related field or equivalent experience.

Critical Skills

• 9+ years of relevant experience in regulatory compliance. Controlled substances compliance experience, pharmacy, or federal/state pharmaceutical regulatory enforcement backgrounds are a plus.

• Able to lead and manage a team of direct reports and ensure high quality work products that are completed efficiently and effectively.

• Able to work independently and deal with complexity and ambiguity in a dynamic environment.

• Able to manage multiple assignments, optimally prioritize, and make effective use of time based on internal and external factors.

Additional Skills

• Proficient computer skills, including Microsoft Office applications; Salesforce knowledge is a plus.

• Possess a high-speed internet connection.

• Able to make sound, regulatory decisions by leveraging interviews, data analysis, and relevant information from other pertinent sources.

• Organized, results-driven, resourceful, and can use tact and sound judgment when dealing with direct reports, customers, and peers.

• Strong interpersonal skills that support effective internal and external stakeholder engagement.

• Able to thrive in a fast-paced, yet detail-oriented, environment.

• Excellent verbal and written communication skills, including the ability to communicate clearly and confidently at all levels.

• Embrace the diversity of people, thought, and style.

• Seek opportunities to improve operational excellence through people, processes, and technology.

Travel

* Able to travel up to 10%.

Physical Requirements

• General Office demands

• Ability to operate a laptop

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, pleaseclick here.

Our Base Pay Range for this position

$100,700 - $167,900

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.

Join us at McKesson!