Manager, Investigations @ McKesson

Job Information

Job Description:

Key Responsibilities

  • Initiate and conduct investigations into suspect product notifications, including adhering to required timelines from discovery/notification to investigation initiation to filing necessary documents with external regulators; assess any linkage to other notifications and/or investigations.
  • Support development and implementation of policies and procedures related to regulated activities in the distribution centers, including those related to FDA and DEA requirements, among others.
  • Manage communications from McKesson’s U.S. distribution centers to partners, manufacturers, and customers.
  • Initiate notifications to McKesson’s U.S. distribution centers with clear guidance with respect to handling suspect and illegitimate product.
  • Direct coordination of suspect product investigations with other internal teams and personnel, including but not necessarily limited to McKesson’s Global Security and Safety team, and Distribution Regulatory Support Team.
  • Document, update, and maintain investigation reports in a timely manner.
  • In accordance with internal SOPs, lead process for closing investigations and filing necessary documents with U.S. FDA and other external regulatory bodies.
  • Follow defined process to obtain necessary approvals for completed investigations.
  • Manage document record retention requirements in accordance with internal SOPs.
  • Establish effective partnerships across the business, such as Internal Audit, Legal, Operations, Global Security and Safety, Distribution Regulatory Support, Product Management and Purchasing.
  • Ensure compliance with policies and relevant federal and state laws and regulations.

Minimum Requirements

Degree or equivalent and typically requires 4+ years of relevant experience

Critical Skills 

  • 5+ years of experience in quality, regulatory, compliance, legal, business, or related field.
  • Corporate/Internal Investigations experience; internal audit experience; fraud & abuse and/or compliance & ethics background.
  • Ability to conduct complex initiatives in a self-directed manner, with minimal oversight, and to deliver superior results in a timely manner.
  • Must have excellent written and verbal communication skills to effectively communicate with a broad spectrum of business segment personnel and senior management.
  • Excellent prioritization skills to manage multiple, ongoing initiatives as may be required in a changing business environment.
  • A superior level of professionalism to work effectively with internal and external personnel and promote the reputation and integrity of the General Counsel Organization.
  • Excellent decision making and judgment capability.
  • Experience working with sensitive information and can maintain confidentiality.
  • Highly organized with meticulous attention to detail.
  • Strong analytical and organizational skills as well as problem-solving capabilities.

Additional Knowledge & Skills

  • Experience with FDA regulations and rules, including the Drug Supply Chain Security Act (DSCSA).
  • Experience with DEA regulations and rules, including the Controlled Substances Act (CSA)
  • Compliance auditing and monitoring skills a plus.
  • Experience working in a large, matrixed institutional setting preferred but not required.

Experience Level: Mid-Senior
Work From: Onsite

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