Compliance Associate Director Berkeley Heights, New Jersey
Title: Associate Director, Compliance (Patient Services, Market Access)
Job Type: Permanent
Primary Location: Berkeley Heights, New Jersey
Vignetic is looking for an Associate Director of Compliance (Patient Services, Market Access) who will have the responsibility for implementing, supporting, and maintaining key compliance systems and processes across a variety of compliance program elements focusing on Patient Services and Market Access. In this role, the individual will support the Senior Director, US Compliance Lead and be responsible for the development, implementation, and maintenance of the Patient Services Compliance Program.
Role & Responsibilities:
- Implement existing and newly developed written policies, procedures, and standards of conduct, leading effective training programs, conducting risk assessments, and developing risk mitigation plans, developing and executing monitoring and auditing plans, and directing investigations to respond promptly to detected offense and undertake corrective actions.
- Ensure compliance support is aligned with company values and global standards and consistent with local industry code, best practices, PhRMA Code, and U.S. laws and regulations including HIPAA.
- Must have experience, from a Compliance perspective, working with Patient Services programs, Market Access, reimbursement field teams, patient engagement field teams, data management and privacy.
- Develop the overall approach where compliance is a core component of daily interactions with all stakeholders.
- Understand the importance of embedding and championing compliance and ethics throughout the organization.
- Excellent communication skills and act as a change agent to engender a culture of compliance within the organization.
Essential Skills & Qualifications:
- Bachelor’s degree is required, with an advanced degree in a relevant discipline (e.g., J.D., MBS, other) a strong plus.
- Experience in the Pharmaceutical/Biotech/Life Sciences industry is required.
- A minimum of 5 years pharma, biotech, other life sciences- related Compliance experience specializing in Patient Services and Market Access is required.
- Ability to work, collaborate, and communicate globally and across multiple cultures with awareness and sensitivity.
- Strong attention to detail and the ability to think and operate both strategically and operationally is important.
- Working knowledge of U.S. PhRMA Code, Anti-kickback, and FDA law and regulations, and compliance program standards and requirements; knowledge of data protection and privacy/HIPAA.