Senior Director Corporate Compliance at Mallinckrodt Pharmaceuticals in Hazelwood, Missouri

Job Description:

Job Title

Senior Director Corporate Compliance

Requisition

JR000011418 Senior Director Corporate Compliance (Open)

Location

US Specialty Brand Headquarters - USA501

Additional Locations

Hampton, NJ

Job Description

Summary

The Senior Director of Corporate Compliance, together with other members of the Compliance Department, will assist in developing, implementing and maintaining an effective Corporate Compliance Program that meets or exceeds regulatory standards for effective healthcare compliance programs, including the Office of Inspector General (OIG) Guidelines, the U.S. Federal Sentencing Guidelines, and the Department of Justice (DOJ) guidance.

This individual will be responsible for designing, implementing and managing compliance policies and procedures, processes, certifications and disclosures to applicable regulators. This position will also lead the Compliance training strategy and will manage the development and implementation of training initiatives for the Corporate Compliance Program. The Senior Director of Corporate Compliance will also champion an enterprise-wide culture of compliance and business ethics and he or she will provide effective guidance to internal and external business partners. This position will report to Mallinckrodt's Chief Compliance Officer.

Essential Functions

• Manage the development and implementation of the Compliance work plan ("work plan") designed to evaluate and enhance existing compliance programming to ensure compliance with policies, the laws and regulations and other regulatory guidance.


• Responsible for establishing and revising existing policies and procedures to support the work plan.


• Proactively manage work plan objectives and action items by coordinating within Compliance department and with other functions.

• Oversee the design and implementation of training initiatives for the work plan, including live web-based sessions and LMS content. Manage the creation of content and delivery of effective training to new and existing employees, working in partnership with compliance colleagues to educate Commercial and S&T colleagues on meeting the obligations of the work plan requirements and aligned with OIG Guidance on elements of an effective compliance program.


• Responsible for the reporting and disclosure obligations under the work plan including: Compliance Program Review report, disclosure log, executive and employee annual certifications to activities within their areas, Board composition changes, managing reportable events and training completion.


• Support third party reviews of the Compliance Program including production of policies and procedures, transaction analysis / data sampling and requested reports.


• Work with Compliance leaders within the team to ensure commercial strategies are aligned to work plan policies and procedures.


• Collaborate with compliance colleagues and internal audit to ensure the monitoring and auditing work plan is aligned with OIG obligations.


• Assist with the preparation of work plan communications, meeting materials and status updates to the Board of Directors' and Management Compliance Committee.


• Manage a budget for spend related to the work plan.


• Assist with the annual risk assessment process and planning, including the identification of risks associated with business activities and OIG obligations and the implementation of mitigation plans to address the risks.


• Interface and collaborate effectively with Commercial management, S&T, Strategy/New Product Commercialization, Medical Affairs, Legal, Human Resources, Public & Government Affairs, Communications and Finance departments as required.


• Collaborate and coordinate with compliance team members who provide support across all elements of Mallinckrodt's Compliance Program

Minimum Requirements

Education / Experience / Skills:

Education:

• BS, BA (or equivalent) from accredited university; MBA/JD/advanced degree a plus.

Experience:

• Strong business ethics and integrity.


• 10+ years of pharmaceutical, healthcare or relevant agency experience including compliance program management.


• Significant experience managing compliance within the context of a CIA and DPA highly desirable.

• Knowledge of and experience with laws, regulations and industry guidance that affect the pharmaceutical industry including: OIG, PhRMA Code of Conduct, American Medical Association, Federal transparency laws, State disclosure laws, False Claims Act, Anti-Kickback Statute, anti-bribery laws and state price reporting statutes.


• Demonstrated in depth knowledge of sales & marketing processes and policies.


• Demonstrated ability to read, analyze, and interpret business and regulatory information and legal advice.


• Strong project and time management skills with the ability to handle multiple tasks, set priorities, meet deadlines, and develop process efficiencies where required.


• Able to work independently and know when to appropriately escalate an issue for resolution.


• Demonstrated experience in handling confidential and sensitive situations and information with ability to exercise a high degree of judgment and discretion.


• Demonstrated ability to communicate effectively with individuals up, down, and across the organization.


• Demonstrated leadership skills, including ability to lead change efforts through effective communication and persuasion.


• People and team management experience desirable


• Proficient in Microsoft products (Outlook, Word, Excel, PowerPoint)

Organizational Relationship/Scope:

The role will interact internally with senior executives, other individuals at all levels within compliance, cross functionally, and will also interact with external business partners. This role will have a direct report.

Working Conditions:

Works within a normal office environment. Travel ~ 10% - 20% domestic travel required

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