The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Veloxis Pharmaceuticals is an Asahi-Kasei Group Company based in Cary, NC. Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. Veloxis provides a dynamic and innovative place to work that encourages professional development and embraces diversity. We seek creative, intelligent, action-oriented, and passionate individuals who thrive in a collaborative team environment. If you are interested in being part of a patient-centric company, then we invite you to learn more about the employment opportunities available at Veloxis. Our success is tied to the contribution of every team member, which is why we provide a valuable and competitive compensation package that includes health and insurance benefits, training, and development opportunities, as well as performance-based bonus eligibility.

Company:

Veloxis Pharmaceuticals, Inc.

Job Description:

The Manager, Compliance Monitoring and Analytics is primarily responsible for executing the Company’s compliance monitoring program with a focus on live monitoring activities (e.g., field ride-alongs, speaker programs, advisory boards, steering committees), desktop monitoring activities (e.g., transfers of value with Health Care Professionals) and supporting other areas of the Company’s ethics and compliance program (e.g. training, auditing and investigations).

The incumbent plays a critical role in ensuring adherence to healthcare compliance laws, industry codes, company policies, and regulatory requirements governing pharmaceutical commercial, medical, and clinical activities.

The base compensation range for this role is $105 - 125K. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.

Field Monitoring & Ride-Alongs

• Conducts live field ride-alongs with commercial field representatives (e.g., sales, strategic accounts, field access), and field medical staff to assess compliance with policies and regulatory requirements.
• Observes healthcare professional (HCP) interactions to ensure alignment with approved labeling, promotional standards, and company policies.
• Evaluates adherence to Company guidelines including but not limited to meals with HCPs, educational materials, and appropriate messaging.
• Prepares detailed monitoring reports summarizing observations, risk findings, and recommended corrective actions.
• Delivers timely and constructive feedback to monitored personnel and relevant leadership.

Speaker Programs, Advisory Boards, Steering Committees and other Events

• Conducts live monitoring of speaker programs (in-person and virtual), ad boards, steering committees and other events to assess compliance with company policies and industry standards.
• Evaluates content delivery, adherence to planned agendas, attendee appropriateness, event logistics and other pertinent risk areas associated to these types of events.
• Assesses program compliance with applicable industry codes (e.g., PhRMA Code) and anti-kickback risk considerations.
• Documents findings and collaborates with appropriate departments on remediation plans as needed.
  

Desktop Monitoring & Analytics

• Assists in creating monitoring plans to assess compliance risk areas for the business.
• Performs desktop monitoring based on the monitoring plan of Company activities using internal systems and data analytics.
• Reviews data related to emails, expenses, call notes, speaker programs, meals, etc. as required by the annual monitoring plan and in collaboration with manager
• Identifies trends, red flags, and potential areas of risk.
• Develops monitoring dashboards and analyze metrics to identify trends and assess the effectiveness and efficacy of monitoring activities.
• Prepares periodic compliance reports for leadership.

Other Responsibilities

• Conduct ad-hoc reviews, inquiries and investigations as required by the Director, Ethics & Compliance on risk areas or compliance violations as they arise.
• Assist in developing and delivering compliance training as needed.
• Support enhancements to monitoring methodologies and standard operating procedures.
• Assist Auditing Lead with Transparency / Aggregate Spend Oversight including data collection, reconciliation, and accuracy of HCP/HCO spend for federal/state reporting. Identify process gaps and drive improvements in data flow, documentation, and reporting governance.

• Bachelor’s Degree in accounting / auditing / healthcare administration, or a related field from an accredited university/college.
• At least 5 years’ relevant experience in the life sciences industry with 2-3 years of related experience in healthcare compliance, preferred.
• Ability to organize, plan, and prioritize work in a deadline-driven work environment, and exercise sound judgment.
• Understanding of the US Physician Payment Sunshine Act, FDA regulations, Anti-Kickback Statutes, etc.
• Collaboration and communication skills related to delegation of work as well as management status updates.
• Strong analytical skills, with the ability to quality check work with a keen attention to detail.
• Strong level of comfort with data analysis, including the ability to work with large amounts of data and organize results in a meaningful way to identify trends and potential red flags.
• Strong MS Office skills (Word, Excel, PowerPoint) required. Experience in Concur, administration of corporate card programs, and Veeva, a plus.
• Strong integrity with the ability to discreetly handle sensitive situations.
• Strong written and verbal communication skills, with the ability to work effectively across different functions and locations, including field-based employees across the US.
• Flexibility to adapt to changing priorities and manage activities to meet the needs of the business while maintaining a focus on quality and compliance.

Travel Requirements: Domestic:- ~30%\

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As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.