DescriptionPosition Overview:The Compliance Operations Manager executes the day-to-day operations of Mayne Pharma's Compliance & Risk Program. Working closely with business stakeholders, this role implements compliance initiatives, manages operational processes, leads cross-functional activities, and supports continuous improvement of the compliance program. The position emphasizes execution, operational excellence, and project management across monitoring, transparency reporting, training, policy administration, and investigations to help ensure compliance with applicable healthcare laws, regulations, and company policies.
The position reports to the VP, Global Head Compliance & Risk and is a hybrid position based in Raleigh, NC.
Specific ResponsibilitiesCompliance Program Operations- Develop, implement, and maintain compliance policies, procedures, guidance, and training.
- Manage Compliance Committee meetings, materials, and follow-up activities.
- Deliver compliance onboarding and targeted training for employees, as needed.
- Oversee, in conjunction with Global Head Compliance & Risk, compliance risk assessments and implementation of mitigation activities.
- Lead continuous improvement initiatives that enhance compliance program effectiveness.
- Provide practical compliance guidance to business partners while supporting business objectives.
Monitoring & Transparency- Execute compliance monitoring and auditing activities, analyze trends, and communicate findings and recommendations.
- Manage operational aspects of federal and state transparency reporting, including data validation, certifications, and disclosures.
- Track remediation activities and support ongoing monitoring of corrective actions.
Investigations- Own internal investigations, including case intake, evidence collection, interviewing, case tracking, and recommendations for corrective action.
Key Competencies/Requirements:- Bachelor's degree required.
- Minimum of 5 years of compliance experience in the pharmaceutical, biotechnology, or life sciences industry.
- Knowledge of healthcare compliance laws, regulations, and industry codes (e.g., Anti-Kickback Statute, False Claims Act, FDA promotional requirements, PhRMA Code, etc.).
- Experience supporting compliance monitoring, auditing, policy administration, or operational compliance programs.
- Experience with federal and state transparency reporting, including Open Payments.
- Experience with compliance technologies such as learning management systems, case management systems, expense management systems, or transparency reporting platforms.
- Strong project management and organizational skills with the ability to manage multiple priorities.
- Excellent written and verbal communication skills.
- Strong analytical skills with exceptional attention to detail.
- Ability to build collaborative relationships across business functions and influence without direct authority.
Physical Requirements:- Occasional travel required
