Keenova logo

Compliance Specialist

Keenova

Malvern, PAHybridPosted 52 days ago
Full TimeEntry LevelCorporate FunctionsPharmaceutical
Original posting ↗

Summary

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.

Job description

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.

Compliance Monitoring (85%)

  • 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.

Cross Functional Support (15%)

  • 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.

Education & Experience

  • BA/BS degree is required, preferably in business, finance, science, or a related field.
  • Experience in the pharmaceutical, healthcare, or other regulated industry preferred.
  • Experience reviewing, analyzing, or reporting data preferred.

Knowledge

  • 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.
  • Familiarity with pharmaceutical or healthcare compliance requirements preferred.

Skills & Abilities

  • 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.

Physical Requirements

  • Ability to work in a hybrid environment, including three designated onsite days per week.
  • Ability to travel up to 20% to support live monitoring and other compliance activities.

Requirements

  • BA/BS degree is required, preferably in business, finance, science, or a related field.
  • Experience in the pharmaceutical, healthcare, or other regulated industry preferred.
  • Experience reviewing, analyzing, or reporting data preferred.
  • 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.
  • Familiarity with pharmaceutical or healthcare compliance requirements preferred.
  • 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.

Benefits

  • Competitive Pay
  • Total Rewards Package

Company overview

Keenova Therapeutics is a leading global specialty pharmaceutical company formed through the 2025 merger of Mallinckrodt and Endo Pharmaceuticals, followed by the spin-off of its generics business as Par Health. Headquartered in Dublin, Ireland with a strong U.S. manufacturing footprint, Keenova focuses on developing, manufacturing, and commercializing branded therapeutics for patients with rare or unaddressed conditions. The company operates across diverse therapeutic areas including immunology, urology, hepatology, ophthalmology, orthopedics, and critical care. Keenova's portfolio features established brands such as XIAFLEX for Dupuytren's contracture and Peyronie's disease, and Acthar Gel for inflammatory and autoimmune conditions. With 2024 pro-forma revenue of $1.7 billion and over 1,600 employees, the company maintains a patient-centric approach, pairing high-quality therapeutics with comprehensive support services. Keenova plans to pursue a New York Stock Exchange listing in 2026, positioning itself as a dedicated specialty pharmaceutical company committed to addressing significant unmet medical needs through innovative therapeutic solutions.

Explore more jobs of your matchFind more biopharma roles with GetBioJob.