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The SeniorManager, Investigations, Compliance & Ethics
will serve as a member of the Product Safety Review Team and work on investigations related to notifications of suspect product for McKesson's U.S. Pharmaceutical Solutions & Services distribution businesses, located in Irving, TX. The Senior Manager will report directly to the Director, Compliance & Ethics (within McKesson's General Counsel Organization). The Senior Manager will be responsible for conducting suspect product investigations, making determinations of illegitimate product, appropriately documenting investigations, and filing applicable documents with external regulators.
The ideal candidate will have experience in the health care and/or drug distribution industry, with a background in conducting internal investigations or performing audits. He or she 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 the demonstrated ability to collaborate effectively with large teams consisting of business, legal, compliance, audit and HR colleagues in a highly-matrixed environment. Key Responsibilities
Typical Minimum Qualifications
- 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.
- 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 McKesson's Global Security and Safety team, Distribution Regulatory Support Team, and Quality Operations.
- 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.
- Followed 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, Quality Operations, Global Security and Safety, and Distribution Regulatory Support.
- Ensure compliance with policies and relevant federal and state laws and regulations.
- 7+ years of relevant experience
- Degree or equivalent
Additional Preferred Knowledge & Skills
- 7+ years' experience in compliance, legal, business or related field.
- Experience in and comfort with working in ambiguity
- Pays meticulous attention to detail and verifies work product and conclusions are well supported and accurate
- Exercise professional judgment and propose value added solutions in all aspects of performance.
- Possesses 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.
- Prioritizes multiple, ongoing initiatives and efficiently re-prioritizes such responsibilities, as may be required in a changing business environment.
- Applies sound judgment and makes decisions which are supportable and appropriate given the available information.
- Demonstrates the ability to work with sensitive information and maintain confidentiality.
- Strong analytical and organizational skills as well as problem-solving capabilities.
- Experience with FDA regulations and rules, including the Drug Supply Chain Security Act (DSCSA).
- Compliance auditing and monitoring skills a plus.
- Corporate/Internal Investigations experience; internal audit experience; fraud & abuse and/or compliance & ethics background
- Experience working in a large, matrixed institutional setting
- Knowledge of distribution operations
- Background as paralegal
- An outstanding record of academic achievement, including an undergraduate degree
McKesson is an Equal Opportunity/Affirmative Action employer.
- Ability to operate a laptop
- Travel to distribution centers when needed, up to 20%
All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.Qualified applicants will not be disqualified from consideration for employment based upon criminal history.
McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to McKessonTalentAquisition@McKesson.com . Resumes or CVs submitted to this email box will not be accepted.
Current employees must apply through the internal career site. Join us at McKesson!