Job Description
Job Description
POSITION SUMMARY :
We are seeking an experienced and detail-oriented Director of Healthcare Compliance to support the company’s compliance program, ensuring adherence to applicable healthcare laws, regulations, and ethical standards. This role will focus on ensuring compliance with company policies, Federal Sunshine Reporting, State Marketing Reporting, and State Price Transparency Reporting, among other key compliance obligations. The role will also serve as a lead for compliance training and managing the Compliance Workplan.
The ideal candidate will have extensive experience in healthcare compliance, a deep understanding of pharmaceutical industry regulations, and the ability to implement robust compliance systems that mitigate risk while fostering a culture of integrity. Salary range NY and CA $188,115 - $221,302 / National $169,296 - $199,171.
ESSENTIAL DUTIES AND RESPONSIBILITIES :
- Develop, implement, and continuously improve the company’s healthcare compliance program to meet federal, state, and industry standards
- Provide guidance to employees on emerging compliance risks, regulatory changes, and industry’s best practices
- Foster a culture of compliance and ethical behavior across the organization through training, communication, and engagement
Federal and State Reporting Obligations
Oversee and ensure timely and accurate reporting under the Federal Sunshine Act (Open Payments Program), including the tracking and disclosure of payments and transfers of value to healthcare providers (HCPs) and teaching hospitalsManage State Marketing Reporting obligations, including compliance with state-specific requirements for promotional activities, payments to HCPs, and sample distributionsLead compliance with State Price Transparency Reporting laws by ensuring timely and accurate disclosure of drug pricing, price changes, and supporting documentation as required by state regulationsMonitoring and Auditing
Design and execute monitoring and auditing processes to assess compliance with healthcare laws, company policies, and reporting obligationsIdentify areas of risk or non-compliance and implement corrective actions to address gaps in compliance processesRegularly review and update compliance policies and procedures to reflect changes in the regulatory environmentPolicies, Training, and Education
Develop and maintain policies and procedures related to healthcare compliance, including interactions with HCPs and promotional activitiesProvide targeted training programs to employees, contractors, and business partners on healthcare compliance topics, including Sunshine Act, state laws, and anti-kickback regulationsServe as the subject matter expert for compliance-related inquiries and provide guidance to teams on adhering to applicable laws and policiesCross-Functional Collaboration
Partner with Commercial, Medical Affairs, Legal, Regulatory, Finance, and other departments to ensure compliance is integrated into business operationsCollaborate with the Pricing and Market Access teams to ensure accurate and compliant price reporting processesRisk Management and Investigations
Support risk assessments to identify and mitigate potential compliance risks in business activitiesSupport internal investigations into compliance concerns, ensuring appropriate documentation, resolution, and reportingMonitor and address industry enforcement trends, government settlements, and compliance benchmarks to proactively mitigate riskKNOWLEDGE AND SKILL REQUIREMENTS :
Education
Bachelor’s degree. Advanced degrees (e.g., JD, MBA, MPH) preferred or commensurate industry experience.Experience
Minimum of 7 years of experience in healthcare compliance within the pharmaceutical or biotechnology industry.Proven track record of managing Federal Sunshine Reporting, State Marketing Reporting, and State Price Transparency Reporting obligations.Extensive knowledge of healthcare regulations, including the Sunshine Act, Anti-Kickback Statute, False Claims Act, FDA promotional regulations, and state-specific laws.Skills and Competencies
Strong analytical and organizational skills to manage complex reporting requirements and deadlines.Exceptional communication and interpersonal skills to influence and engage cross-functional teams and external stakeholders.Detail-oriented and able to manage multiple priorities in a fast-paced environment.WORKING CONDITIONS :
PHYSICAL DEMANDS : While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.WORK ENVIRONMENT : The noise level in the work environment is usually moderate. Some travel may be required.Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.
Salary : $169,296 - $199,171
