72 applicants

Company

EVERSANA · 21 hours ago

Executive Director Compliance & Regulatory

Yardley, PA

Full-time

Remote

Director/Executive

$177K/yr - $239K/yr

15+ years exp

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Responsibilities

Leading the quality and compliance efforts for multiple client projects and ensuring all local and federal regulations are followed.

Contributing to and managing a team of Eversana internal employees and external vendor in the design, development, and delivery of complex projects covering a variety of subject matter areas.

Strong understanding of healthcare compliance and enforcement environment.

False Claims Act, Anti-kickback Statute, anti-bribery considerations, and CDE rules and regulations.

Food Drug and Cosmetic Act U.S.C. Title 21, Chapter 9.

Affordable Care Act.

False Claim Act 31 U.S.C. 3729-33.

Anti-Kickback Statute Social Security Act SEC. 1128B. [42 U.S.C. 1320a-7b].

PhRMA Code.

Prescription Drug Marketing Act.

HHS-OIG Guidelines.

HIPAA.

Other State Laws.

General Data Protection Regulations (GDRP).

Commercial compliance consulting: risk assessments, policies and SOPs, training materials.

Transparency reporting and aggregate spend: process assessments, policies and SOPs, business process outsourcing and managed services.

Knowledge of commercial compliance and ability to conduct training as it relates to the Life Sciences industries and how they effectively and compliantly interact with HCPs/HCOs and operate in the marketplace.

Supporting development of proposals.

Auditing and Monitoring: plan development, live monitoring, transactional reviews, data analytics and outsourced managed monitoring services.

Working knowledge of global (EU) data laws at the country specific level.

Data Management and Data Protection: must be the lead advocate in managing the compliance and operations oversight to handling Third Party or Client Data following the Security and Privacy policies within Deployment Solutions.

Program and process design: compliance programs, HCP engagements, FMV, grants and contributions management (Honorarium, Sunshine Act).

Sales activities (expense report sign in sheets etc): Accuracy of Data and Records and QA auditing Sales Force.

Drug Samples distributed to prescribers (FDA).

Any transfers of value provided to U.S. licensed physicians and teaching hospitals, including Clinical Research Spend (CMS’ Open Payments Program).

Specific State regs on Aggregate Spend reporting.

Vendor Credentialing.

Internal projects and initiatives as needed specific for Deployment Solutions.

Oversight of the creation of content of templates and training materials to streamline and optimize new project start-up and team-member onboarding.

Managing and collaborating with project teams in the design, development, and delivery of client deliverables.

Providing guidance on oversight, tracking, and monitoring of project status and delivery specific to Deployment Solutions Compliance activities.

Providing high level input to, and ensures the development of, client reports and presentations and delivery of all or significant portions of findings to client.

Leveraging Life Sciences experience and business acumen to recommend improvements and alternative solutions to resolve client challenges.

Sharing subject matter expertise with others to elevate our capabilities to deliver world-class solutions for clients.

Adverse Events and Product Complaints fully understood and the advocate for Deployment Solutions.

On the Road or Virtual Field auditing the Sales Reps.

Internal Auditing and Monitoring program and internal review of Business activity related to COC and the Compliance Program. Random and For Cause elements.

Established and manage Corrective Actions and Disciplinary actions program from inception to completion.

Working closely with Corporate Quality & Compliance and other BU leadership to align with Policy, Practices, and Compliance Escalations and provide 'Quality at the Source' oversight to ensure Compliance to Regs and Laws.

Institute a Quality Management System and Compliance program within Deployment Solutions Operations, including 1- Developing robust SOPs, Work Instructions and Job Aids, so all Job Roles are accountable for their responsibilities within each area of Deployment Services Operations 2- Compliance oversight to Training to operations Policy and Procedures 3- Operations support of Client and Internal Audits 4-Operational support to Non Conformance and CAPAs 5-Operational Continuous Improvements determined by MBR and QBR.

All other duties as assigned.

Qualification

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Healthcare ComplianceCompliance PoliciesPharmaceutical RegulationsCompliance Program DevelopmentRisk-Based AnalysisTraining DevelopmentData ProtectionAuditingMonitoringMicrosoft SuiteCertification in Healthcare ComplianceProject Management

Required

Bachelor's Degree (life sciences, compliance law, public policy, pharmaceutical marketing, business, education, finance/accounting or related discipline preferred)

Strong understanding of healthcare compliance and enforcement environment

Development and oversight of compliance policies and procedures including adaptation of policies and procedures from a global to local perspective

Substantial knowledge and understanding of industry including, but not limited to, OIG Compliance Program Guidance for Pharmaceutical Manufacturers, PhRMA Code on Interactions with Healthcare Providers, Anti-Kickback Statute, Sunshine Act, FCPA, UK Bribery False Claims Act, FDA rules and regulations and other industry guidance, and other issues affecting the development, sales, promotion and marketing of pharmaceutical and biological products

A minimum of 15 years’ of direct compliance experience in a compliance department of a healthcare company (Diagnostics, Medical Device, Pharma/Biotech)

At least 5 years’ experience leading/transforming a strong compliance team and successfully managing and developing people

Knowledge of federal and state laws and industry requirements affecting the biotech/pharma/device laws

Specific prior experience in the development/deployment of a company-wide compliance program, including all of its elements: policy framework, Compliance operations, risk-control matrices and dashboards, training & awareness, auditing and monitoring, investigations, communications and Compliance culture/leadership

Sophisticated ability to apply a risk-based analysis to compliance issues and demonstrate creativity and flexibility in developing solutions that satisfy both business requirements and legal obligations

Experience in successfully innovating compliance, embedding compliance as a key business differentiator and competitive advantage in all aspects of the business