Associate Director, Compliance Business Partner (Pharmaceuticals)
About the role
Veloxis Pharmaceuticals, Inc., an Asahi-Kasei Group company, is seeking an Associate Director, Compliance Business Partner to join our dynamic team. This role serves as a trusted advisor to assigned business functions, driving proactive, risk-based approaches that support business objectives and enable compliant growth.
Responsibilities
- Business Partnership & Advisory
- Serve as the primary Compliance partner to assigned business functions, including 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.
- 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.
- 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.
Qualifications
- 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 application 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 to 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.
Benefits
We offer a competitive compensation package that includes health and insurance benefits, training, and development opportunities, as well as performance-based bonus eligibility.
Pay
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.
Schedule
This role is offered as a hybrid position, with preference given to candidates located near Cary, NC; however, remote candidates based within the U.S. will be considered based on qualifications and experience.