Description: Compliance Investigations Senior Manager is accountable for (1) the management and conduct of compliance investigations, including oversight of the investigation of possible violations of compliance policies, laws or regulations and (2) the management and operation of the Code of Conduct Helpline and the related Disclosure Log and incident management database. The Senior Manager will work closely with the Legal Department and Human Resources regarding the process for the investigation of possible violations of company policy, laws or regulations.
Major Responsibilities
· Personally conduct and/or manage the internal investigation by others (including Employment Practices Partners and Compliance & Ethics staff) of alleged compliance policy violations to ensure that such allegations are promptly, thoroughly and objectively addressed, and that discipline is applied in a fair and effective manner and other appropriate corrective action is taken when policy violations are confirmed
· Identify policy and legal issues and apply relevant policy and law to make recommendations regarding conduct and resolution of investigations
· Engage in fact-finding, including witness interviews, relevant to routine as well as complex allegations of violations
· Identify, retrieve, organize, review, analyze and, as needed, summarize documents and data relevant to alleged violations
· Oversee the operation of the Code of Conduct Helpline to assure that reports of violations are appropriately prioritized and investigated, that responses to reporters are consistently prompt, accurate and up-to-date, that planned corrective action is implemented in a timely and appropriate manner, and that investigation documentation is collected and maintained in the incident management database
· Maintain the Disclosure Log of potential legal violations as mandated by the Corporate Integrity Agreement
· Coordinate with the Legal Department to assure that all OIG and other government reporting obligations relating to compliance investigations and violations are met
· Provide regular reports to the Compliance Officer, the Business Integrity and Assurance Team and other senior leaders regarding investigation results, Helpline trends and the contents of the Disclosure Log
· Undertake review and root-cause analysis necessary to identify and correct any programmatic compliance-related issues discovered through the investigation and Helpline processes
· Function as Compliance & Ethics Department liaison to the Legal Department and outside counsel to assist in data and document collection for government investigations and other litigation matters involving compliance issues
Internal and External Contacts/Customers
· Business Integrity and Assurance Team
· Compliance Leadership Team
· Legal Department and outside counsel
· Employment Practice Partners and other HR Partners
· Corporate Security
· Other compliance groups within the organization
· Sales, Marketing, Medical Affairs and Clinical leadership
· Healthcare Providers
· External Corporate Compliance Professionals
Reporting Relationship
· Direct Reports - None
· Indirect Reports – Administrative Coordinator
· Contracted Personnel and Technical Consultants as needed
Minimum Requirements
· Bachelor’s Degree or higher
· 5-plus years experience in pharmaceutical industry
· Expert knowledge of legal and regulatory requirements applicable to the conduct of pharmaceutical business operations
· Excellent judgment, critical analysis and decision-making abilities
· Excellent oral and written communication and interpersonal skills
· Ability to handle sensitive and confidential information with discretion
· Ability to work proactively and independently with little direction
· Ability to respond to competing priorities across the organization and manage several projects simultaneously
· Advanced skills and ability in computer and database applications
Preferred Background
· Paralegal certificate or law degree
· Experience in compliance or legal function
· Experience working with outside counsel
· Knowledge of company policies and procedures
Qualified candidates please forward by email cover letter outlining compensation, geographical preferences, availability and a professional resume in complete confidence to: Frank Sinclaire - Health Care Division Group Manager, fsinclaire@pailingroup.com
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