Compliance Business Partner
MallinckrodtAbout the role
Job Title
Compliance Business PartnerRequisition
JR000015820 Compliance Business Partner (Open)Location
Malvern, PAAdditional Locations
Job Description Summary
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.
Job Description
Business Partnership & Advisory
• 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.
Governance, Reviews & Business Processes
• 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.
Risk Assessment, Monitoring & Mitigation
• 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.
Compliance Operations and Program Development
• 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.
Training & Capability Building
• 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.
Leadership & Team Collaboration
• 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.
Requirements of this position include:
• Strong knowledge of various laws, regulations, and industry guidance relevant
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