Compliance Business Partner

Mallinckrodt Pharmaceuticals•Malvern, PA

2d•Hybrid

About The Position

The Compliance Business Partner, All Brands, is a key member of the Corporate Compliance team and serves as a strategic advisor to U.S. Commercial and R&D functions. Reporting to the US Head of Compliance Business Partnership, this role supports the development and execution of risk-based compliance strategies and ensures alignment of business activities with applicable laws, regulations, industry guidance, and Company policies. The Compliance Business Partner acts as a primary compliance contact for assigned business functions, proactively identifying and mitigating compliance risks, supporting monitoring and investigations, and advancing a strong culture of ethics and compliance across all brands. The role requires strong judgment, collaboration, and the ability to translate regulatory requirements into practical, business aligned solutions.

Requirements

Strong knowledge of various laws, regulations, and industry guidance relevant to the Company’s Compliance program, including federal and state government price reporting laws, fraud and abuse and anti-kickback statutes, PDMA, DOJ, OIG and PhRMA guidelines, state and federal aggregate spend reporting laws and corporate integrity agreements.
Subject matter expert on key activities, processes, policies and procedures to maintain and improve Company controls.
Subject matter expert on external regulations and internal processes, policies and procedures relevant to identified areas.
Experience in supporting US pharmaceutical company operations.
Solid judgment and business acumen and understanding of commercial strategies and the ability to assess compliance risks and mitigation strategies in that context.
Experience working in a business environment across multiple functions and geographies, with a high level of responsiveness and with a strong customer service orientation.
Excellent communication skills, both oral and written, enthusiastic, self-motivated, efficient, able to handle heavy workload, able to proactively identify short and mid-term business needs to develop strategies and to manage responsibilities independently as well as facilitate teamwork.
Able to work accurately with an appropriate sense of urgency and function effectively and efficiently in a fast-paced and dynamic environment.
Strong interpersonal skills, including diplomacy, flexibility and collaboration and the ability to interface effectively throughout all levels of the organization as well as with external parties, and adaptable to circumstances and variety of cultures.
30% or more travel required based on business needs.
Bachelors degree is required (Business, Finance, Science preferred).
5-8 years of pharmaceutical, compliance or legal experience required with at least 5 years of experience supporting global commercial organizations.
Demonstrated ability to build and manage effective relationships with strong inter-personal skills and business acumen.
Must be an active, highly productive, and collaborative member of the Compliance Department who works well across functions and with the ability to influence with authority.
Exceptional communication and presentation skills required, with demonstrated success inspiring confidence and support for Compliance initiatives within the organization.
Outstanding verbal and written communication skills, with the ability to distill and communicate complex issues in a simple way and influence for greater outcomes.
Ability to thrive in a fast-paced, innovative environment with the ability to handle multiple, conflicting priorities while managing a substantial workload.
Highly self-motivated, with the ability to quickly gain trust and credibility from team members and stakeholders.
Strong team player that is customer and solution-oriented, with the ability to understand and differentiate approach to complex compliance matters.
Advanced Microsoft Excel skills.
Strong analytical skills.
Familiarity with internet search tools.
Strong organizational and documentation skills.

Nice To Haves

Advanced degree or applicable certifications are preferred.
Compliance leadership experience in branded pharmaceuticals and/or R&D and Medical Affairs strongly preferred.
Experience in commercial business and R&D partnership, training, and monitoring/auditing promotional and non-promotional activities is preferred.

Responsibilities

Serve as the primary Compliance partner and advisor to Commercial, and R&D leaders across assigned therapeutic areas.
Provide independent, practical guidance on compliance with applicable laws, regulations, industry standards, and internal policies to support business objectives while minimizing risk.
Proactively identify compliance risks and recommend mitigation strategies, program enhancements, and process improvements.
Partner with business leaders to embed compliance into planning, execution, and decision making.
Represent Compliance on cross functional teams, councils, and committees as assigned.
Review and approve compliance related materials and activities, including: HCP engagements, fee for service arrangements, grants, and IMEs Commercial sponsorships and related documentation Promotional Review Committee and Concept Review activities Commercial annual plans, new product launches, and major meetings/events.
Review and adjudicate exception requests in accordance with Company standards.
Stay current on emerging laws, regulations, and industry trends and communicate relevant developments to Compliance colleagues and stakeholders.
Execute compliance monitoring activities, including live monitoring, in alignment with the Compliance Monitoring Plan.
Document monitoring results, support issue remediation, and track execution of corrective action plans.
Partner with Compliance Operations and business stakeholders to identify root causes, enhance controls, and improve policies, procedures, and business processes.
Support implementation of investigation outcomes, including training and process enhancements.
Collaborate with Compliance Operations to support risk assessments, monitoring planning, and continuous improvement of the Compliance Program.
Contribute to the development, maintenance, and harmonization of compliance policies, SOPs, and standards.
Support enterprise and business unit compliance initiatives, including changes driven by evolving business activities or regulatory expectations.
Support the design, enhancement, and delivery of compliance training programs, including role-based and risk-based training.
Deliver new hire and targeted training (e.g., speaker programs, field-based training) as needed.
Ensure training content addresses regulatory requirements, internal policies, and insights from monitoring and investigations.
Partner with subject matter experts to ensure consistency, relevance, and effectiveness of training materials.
Act as a trusted advisor and delegate to the US Head of Compliance Business Partnership across planning, monitoring, training, and operational activities.
Support Compliance department initiatives beyond primary responsibility as needed to meet organizational objectives and balance workloads.
Foster strong cross functional relationships and a collaborative Compliance team culture.