
Sr. Manager, Compliance & Ethics - PSAS
Est. $96,461 - $230,000 / year
Posted Jul 22 Title: Sr. Manager, Compliance & Ethics - PSAS
Location: Atlanta, GA; Columbus, OH; Dallas, TX
Hybrid role
Current Need:
McKesson’s well-regarded Compliance and Ethics Department is seeking a dynamic individual with compliance experience to serve as the Senior Manager, supporting McKesson’s U.S. Pharmaceutical Solutions & Services (“PSaS”) distribution business. We are looking for a self-motivated, capable, enthusiastic, and dependable person to join our growing team in this collaborative and results oriented position. This individual will play a crucial role in executing standardized work associated with established compliance processes and will gain exposure to strategic projects aligned with our Compliance risk assessment.
Position Description:
As Senior Manager, you will be responsible for supporting and enhancing the overall compliance program within the Distribution Operations, Brand and Generics business segments within McKesson PSaS distribution business. The position will be based in McKesson’s Atlanta, GA; Columbus, OH or Las Colinas, TX office.
The ideal candidate will have broad familiarity with the laws and regulations governing the activities of pharmaceutical manufacturers and distributors, health care providers, pharmacies, and other market participants, as well as a strong executive presence and the demonstrated ability to collaborate effectively with large teams consisting of business, legal, compliance, audit and HR colleagues in a highly matrixed environment. He or she will have broad familiarity with the regulatory requirements under OIG, DOJ, FDA, DEA, state Board of Pharmacy and related laws and regulations.
Key Responsibilities :
1. Compliance Process Execution:
- Implement and monitor day-to-day compliance activities to ensure adherence to company policies and regulatory requirements.
- Conduct routine audits and assessments to identify potential compliance issues and areas for improvement.
- Maintain accurate and up-to-date records of compliance activities, including audit findings and corrective actions.
2. Data Analysis and Reporting:
- Collect, review, and analyze data related to compliance activities and initiatives.
- Prepare detailed reports and presentations for internal stakeholders, summarizing findings and recommendations.
- Utilize compliance management software to track and report on compliance metrics and key performance indicators (KPIs).
3. Regulatory Monitoring and Risk Assessment:
- Stay informed about changes in healthcare regulations, industry standards, and best practices.
- Assist in conducting compliance risk assessments to identify and prioritize potential risks.
- Support the development and implementation of risk mitigation strategies.
4. Training and Communication:
- Participate in the development and delivery of compliance training programs for employees.
- Communicate compliance policies and procedures clearly and effectively to team members and other stakeholders.
- Serve as a point of contact for compliance-related inquiries and provide guidance as needed.
5. Strategic Project Participation:
- Collaborate with cross-functional teams on strategic compliance projects and initiatives.
- Provide input and support based on compliance risk assessments and regulatory requirements.
Minimum Requirements
- Degree or equivalent and typically requires 7+ years of relevant experience.
Critical Skills
- In-depth knowledge of healthcare compliance programs, with a keen focus on pharmaceutical manufacturers and distributors.
- Working knowledge of Federal and State government regulations pertaining to compliance and privacy program requirements
- Excellent verbal and written communication skills
- Process Improvement mindset.
- Strong interpersonal and collaboration skills is key to success in this position. Ability to build and foster relationships with operational, technical, compliance, regulatory, and legal professionals throughout the organization.
- Ability to be responsive while managing multiple projects simultaneously.
- Ability to work effectively with a variety of audiences at all levels of the organization.
- Ability to maintain confidentiality of sensitive information.
Education
- 4-year degree or equivalent experience
Additional Knowledge & Skills
- Specific knowledge of the Drug Supply Chain Security Act (DSCSA), FDA (Food and Drug Administration) laws and regulations, Controlled Substances Act (CSA), and other applicable laws and regulations.
- Certification such as CFE, CCEP, CHC or equivalent a plus.
Must be authorized to work in the US. Sponsorship is not available for this position.