Posted Mar 24 CoverMyMeds requires new employees to be fully vaccinated for COVID-19 as defined by the CDC, subject to applicable, verified accommodation requests.
The Senior Manager, Compliance and Ethics will oversee the enhancement and maintenance of the compliance program for aspects of the McKesson Third Party Logistics (3PL) business. The position will be primarily located in Louisville, KY or located in one of McKesson’s 3PL locations (Erlanger, KY or Mason, OH). The Senior Manager will report directly to McKesson’s Vice President, Compliance & Ethics, CoverMyMeds Access & Adherence (within McKesson’s General Counsel Organization). The Senior Manager will be responsible for ensuring that 3PL has an effective compliance program.
The ideal candidate will have significant legal and/or compliance experience in building, enhancing and maintaining strong compliance programs for pharmaceutical service companies or manufacturers. 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 as well as a strong executive presence and the demonstrated ability to effectively collaborate with large teams consisting of business, legal, compliance, audit and human resources colleagues in a highly-matrixed environment.
Key responsibilities
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Ensures the enhancement and maintenance of an effective compliance program for McKesson 3PL top regulatory risks.
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Supports the businesses’ goals while building and maintaining a strong culture of compliance throughout the organization by, among other things, implementing effective and business-savvy policies, procedures and training; ensuring open and effective lines of communication at all levels of the organization; supporting investigations, risk assessments, audit and monitoring activities; and driving enterprise-wide compliance and regulatory affairs initiatives.
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Establishes and supports effective business processes and controls to ensure the organization is satisfying its regulatory and compliance obligations including remediating any identified gaps in a timely fashion.
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Supports integration and reorganizational activities.
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Establishes effective partnerships across the business and enables functions, such as Internal Audit, Human Resources, IT, Employee Relations, Legal, etc.
Minimum Requirements
5 years of relevant work experience in building, enhancing and maintaining compliance programs focused on wholesale distribution or 3PL programs for pharmaceutical manufacturers or distributors, and the associated healthcare regulatory obligations, such as:
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Building, enhancing and/or maintaining a BOP (Board of Pharmacy)/DEA (Drug Enforcement Agency) compliant program
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Provide AKS (Anti-Kick Back) related program controls
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Overseeing quality assurance programs
Critical Skills
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Broad experience planning, developing, implementing, monitoring and managing healthcare compliance programs for pharmaceutical service companies.
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Proven track record of creating the foundational elements of an effective compliance program such as drafting policies, creating and delivering training, and implementing effective compliance auditing and monitoring programs.
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Significant experience with relevant laws, rules and regulations.
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Familiarity with the principal federal agencies that regulate the health industry, including the OIG, DOJ, FDA, DEA and State Boards of Pharmacy.
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Significant experience working collaboratively on cross-functional and cross-divisional teams.
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Demonstrated experience successfully establishing a culture of compliance, proactively addressing risk, and leading a modern, fully integrated business-oriented compliance program.
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Demonstrated success in developing strong relationships across a company, ideally in a matrixed environment, as well as with relevant government regulators.
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Executive presence, influencing and collaboration skills, and the ability to serve as an ambassador and influencer for compliance and regulatory strategy.
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He or she should present with great credibility and have a strong reputation for honesty, integrity and ethical behavior.
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Deep understanding of business and key business drivers, leveraging this knowledge to create a vision of how risk-based compliance initiatives can work effectively, practically and coherently throughout our organization.
Additional Knowledge or Skills
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Strong written and oral communication skills, including the ability to communicate to all organizational levels.
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Ability to tolerate ambiguity and to remain flexible under pressure.
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Advanced project management skills.
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Effective team player.
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Strategic, business-oriented and pragmatic.
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Strong implementer.
Education
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Bachelor's Degree Required
Travel Expectation - 15-25%
CoverMyMeds is an equal opportunity and affirmative action employer. We embrace diversity and are committed to creating an inclusive environment for all employees. Qualified applicants will be considered for employment without regard to race, religion, gender, gender identity, sexual orientation, national origin, age, disability or veteran status.
