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 Associate Director, Compliance Business Partner is responsible for overseeing day-to-day compliance activities while driving proactive, risk-based approaches that support business objectives and enable compliant growth. This role serves as a trusted advisor to assigned business functions, providing strategic and operational leadership across core compliance activities, including guidance and advisory support, training, monitoring, policy governance, investigations support, and issue resolution.
The Associate Director is expected to influence business decision-making, identify emerging risks, and implement practical solutions that support organizational objectives while maintaining compliance with applicable laws, regulations, industry standards, and company policies. This role partners closely with stakeholders across the organization and helps ensure Compliance is embedded as a strategic enabler throughout all stages of product development, commercialization, and business growth.
We anticipate that the base compensation range for this role is $160-175K. 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.
Business Partnership & Advisory
- Serve as the primary Compliance partner to assigned business functions, which may include Commercial, Medical Affairs, Clinical Development, Market Access, Patient Access, or other functions as assigned.
- Deliver engaging compliance presentations, training sessions, and risk-based communications to business teams, cross-functional stakeholders, and leadership, translating complex compliance requirements into practical and actionable guidance.
- Provide proactive, risk-based guidance on applicable healthcare laws, regulations, industry codes, company policies, and ethical business practices.
- Develop strong, trust-based relationships with internal stakeholders and provide practical, business-oriented compliance solutions that support organizational objectives.
- Support review and approval activities for materials, programs, and initiatives, including presentations, training materials, HCP-facing materials, patient-related materials, data dashboards, and other business activities.
Compliance Program Execution
- Support the development, implementation, and continuous improvement of the Compliance Program.
- Develop and facilitate compliance training programs, including live training sessions, workshops, and e-learning content.
- Create, review, and update compliance policies and procedures and represent Compliance in the development and review of cross-functional policies and business processes.
- Promote awareness of compliance requirements and foster a culture of integrity, accountability, and ethical decision-making across the organization.
Auditing, Monitoring, and Risk Management
- Conduct and support compliance monitoring activities, including field ride-alongs, speaker program monitoring, and other monitoring initiatives.
- Evaluate monitoring results, identify trends and emerging risks, and provide recommendations for process improvements and risk mitigation.
- Partner with business stakeholders to develop, implement, and track corrective actions and remediation plans arising from monitoring, auditing, and other compliance assessments.
- Deliver timely and constructive feedback to monitored personnel and relevant leadership
Other Responsibilities
- Support compliance-related investigations and issue management activities as needed.
- Assist with information gathering, fact-finding, documentation, and issue resolution efforts.
- Support enhancements to monitoring methodologies and standard operating procedures.
- Support Compliance Committee activities, reporting processes, and other compliance governance initiatives.
- Collaborate with Legal, Human Resources, Internal Audit, and other stakeholders to address compliance concerns appropriately.
- Bachelor’s Degree in accounting / auditing / healthcare administration, or a related field from an accredited university/college. Advanced degree (JD, MBA, MPH, PharmD, Master's degree, or equivalent) preferred.
- At least 10 years of relevant experience in the life sciences industry, including a minimum of 5 years of healthcare compliance preferred.
- Experience supporting Commercial, Medical Affairs, Clinical Development, Market Access, or Patient Access functions within the pharmaceutical or biotechnology industry. Trusted advisor who effectively balances risk management with business enablement.
- Demonstrated knowledge and understanding of applicable healthcare compliance laws, regulations and guidance, including but not limited to OIG guidance, AMA guidance, PhRMA Code, Corporate Integrity Agreements, Anti-Kickback Statute, False Claims Act, and US transparency laws and reporting requirements.
- Strong presentation and facilitation skills, with the ability to effectively communicate compliance risks, regulatory requirements, and practical solutions to diverse audiences, including senior leadership and field-based personnel.
- Proven experience building, implementing, and managing an effective compliance program in a growing commercial environment, ideally with experience related to product launches.
- Demonstrated ability to work collaboratively and effectively with diverse cross-functional teams and senior leadership.
- Ability to influence without direct authority and drive compliance outcomes through collaboration, credibility, and effective stakeholder engagement.
- Strong analytical skills, with the ability review and assess work accurately while maintaining a keen attention to detail.
- Demonstrated integrity and the ability to handle sensitive and confidential matters with discretion.
- 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: approximately 20%
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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.
