Head of Compliance Investigations

Mallinckrodt Pharmaceuticals•Malvern, PA

67d

About The Position

The Head of Compliance Investigations provides direction, monitors progress, and conducts confidential investigations of diverse scope into allegations of violation of law, Company's Code of Conduct or company policies. This role has direct responsibility for conducting compliance investigations from the initial assessment of allegations to completing investigative summaries and reporting investigation outcomes to the Chief Compliance Officer, senior management and Executive Leadership Committee. This role is responsible for promoting the Speak-up culture in the organization including developing training materials and communications to team members globally. Primary focus will be enterprise-wide for branded specialty, businesses, including all US-based and international business areas.

Requirements

10 years of experience in compliance, legal and/or forensic accounting/auditing field.
Experience of leading compliance investigations.
Strong educational credentials with an advanced degree such as JD, Accounting degree, CPA and/or CFE preferred.
Successful track record with positions of increasing responsibility in a law or audit firm, a corporation and/or a federal or state health care or enforcement agency.
Working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including fraud, abuse, and anti-kickback statutes, False Claims Act, pharmaceutical and medical device promotion issues, Food, Drug & Cosmetic Act, federal and state government price reporting laws, OIG, AdvaMed and PhRMA guidelines, Anti-corruption laws, OFAC sanctions laws and state marketing compliance laws and PDMA.
Strong leadership skills and ability to communicate in both verbal and written form with all levels of management and employees.
Ability to evaluate complex health care compliance issues and make appropriate recommendations.
Highly analytical thinking with demonstrated talent for identifying and analyzing critical risk areas.
Ability to work with large amounts of data to analyze information while still seeing the "big picture".
Demonstrated excellence in writing investigative reports.
Must possess excellent organizational and planning skills with the capacity to simultaneously handle a variety of complex confidential issues.
Excellent interpersonal, presentation, influencing, negotiation and mediation skills.
Must have the confidence to handle difficult conversations, pressures and deadlines.
Fully engaged and self-starting.
Possess a high energy level and strong work ethic with a commitment to continuous improvement in a dynamic environment that strives to exceed expectations.
Demonstrated ability/experience in an environment of change and continuous improvement.
20% Travel

Nice To Haves

Strong educational credentials with an advanced degree such as JD, Accounting degree, CPA and/or CFE preferred.

Responsibilities

Compliance Investigations & Hotline:
Ethics Hotline - Oversees Company Ethics hotline, including conducting initial assessment and triage to appropriate department. Provide quarterly metrics and reporting.
Conduct Compliance Investigations - Conducts objective and prompt compliance investigations, ensuring appropriate resolution and corrective action, if needed. Key steps of our process:
Assess concern and recommend an investigative approach
Develop investigation work plan & interview questions
Conduct fact-finding by reviewing documents and conducting interviews
Close out the investigation, including root cause analysis, recommended corrective and disciplinary actions, finalize the report, and update the Case Management System.
Facilitate close-out meetings with key stakeholders
Track completion of action items
Work with outside counsel as needed
Reporting & Metrics - Provide progress reports and key metrics of active Compliance investigations
Investigation Oversight & Support:
Investigations Process Support - Ensures effective functioning of our global investigations process, oversees a database of case information, monitors the performance of our investigations process, performs trend analyses, and recommends improvements based on the trend analyses.
Conducts or facilitates periodic training on the investigation process to team members.
Investigation Metrics & Reporting - Analyzes company-wide investigations trends and metrics, creating reports for use by Senior Management.
Assists in preparing investigation metrics and dashboards for Executive Reporting Committees and Compliance Committees.
Promote Culture of Integrity, Policies, Procedures & Tools:
Promote Culture of Integrity in the organization through various projects, including but not limited to, conducting employee surveys, communications, and training materials promoting hotline and ways employees can report concerns.
Assist in implementation of appropriate policies and procedures designed to ensure consistency and timeliness in the investigation and disposition of compliance-related allegations, complaints and reports; ensures that such results are communicated appropriately.
Manage tools and templates for investigations, hotline and case management systems.
Support Compliance Initiatives:
Provide ad hoc support to other members of the Compliance department.
Lead implementation of the departmental projects and key initiatives for Corporate Compliance, as assigned.
Active, productive and collaborative member of Compliance Department who works well across functions, lines of business and geographies.