Compliance Specialist

Mallinckrodt Pharmaceuticals•Malvern, PA

11d•Hybrid

About The Position

The Compliance Specialist supports the execution of the Company’s compliance monitoring program. Primary responsibilities include conducting transaction monitoring, participating in live monitoring activities, reviewing and analyzing data, and documenting monitoring observations in accordance with established procedures. The role also supports the preparation of monitoring reports, tracking of findings and corrective actions, and communication with internal stakeholders and vendors. The Compliance Specialist works collaboratively with members of the Corporate Compliance team and other business functions to support timely and effective monitoring activities.

Requirements

BA/BS degree is required, preferably in business, finance, science, or a related field.
Basic understanding of data analysis, reporting, and data visualization concepts.
Ability to develop working knowledge of laws, regulations, industry guidance, and Company policies relevant to healthcare compliance.
Strong attention to detail and commitment to accurate documentation.
Strong organizational and time-management skills, with the ability to manage multiple assignments and meet deadlines.
Analytical and problem-solving skills, including the ability to review information and recognize potential inconsistencies or concerns.
Effective written and verbal communication skills.
Ability to follow established procedures and appropriately escalate questions or potential compliance concerns.
Ability to work both independently and collaboratively within a cross-functional environment.
Proficiency with Microsoft Office applications, particularly Excel.
Ability and willingness to learn new systems, analytical tools, and healthcare compliance requirements.
Professional judgment and discretion when handling confidential or sensitive information.

Nice To Haves

Experience in the pharmaceutical, healthcare, or other regulated industry preferred.
Experience reviewing, analyzing, or reporting data preferred.
Familiarity with pharmaceutical or healthcare compliance requirements preferred.

Responsibilities

Conduct transaction monitoring activities in accordance with established monitoring procedures, including reviewing transactions and supporting documentation for compliance with applicable policies and requirements.
Participate in live monitoring of promotional and non-promotional business activities, including documenting observations and escalating potential concerns for further review.
Coordinate with internal stakeholders to obtain documentation and information needed to complete assigned monitoring activities.
Review and analyze data to support compliance monitoring activities and identify potential trends, anomalies, or areas requiring additional review.
Perform data validation and quality checks to help ensure the accuracy and completeness of monitoring analyses.
Assist with maintaining compliance reports, dashboards, and analytical tools.
Support the entry and maintenance of monitoring results, findings, and related documentation within the compliance monitoring system.
Assist with tracking open monitoring findings and corrective actions through closure.
Participate in the preparation of monitoring summaries and materials for periodic review with Compliance leadership and collaborate with Compliance team members to identify opportunities to improve monitoring processes and reporting.
Collaborate with Compliance organization and relevant business stakeholders to identify areas of risk, monitoring opportunities and areas of improvement for Compliance and/or operational activities such as enhancements to policies/procedures, processes, training or technology.
Provide ad hoc support to other members of the Compliance department.
Support implementation of the departmental projects and key initiatives for Corporate Compliance, as assigned.