A well respected pharmaceutical company has a need for an Associate Director, Healthcare Compliance - Auditing & Monitoring.
Work will be remote to start, but will resume in office in Princeton, NJ, so you must be able to work onsite when the COVID-19 situation settles down.
work within the Healthcare Compliance North America (HCNA) Group and be based in Princeton, N.J. They will be responsible for assisting with the execution of healthcare compliance monitoring and auditing activities to ensure adherence to company policies and procedures as well as compliance with U.S. state and Federal laws related but not limited to the promotion of branded U.S. products.
Responsibilities include providing overall assistance in reviewing sales, marketing and commercial activities through the promotional and medical review process to ensure that materials and tactics are compliant with company policies and legal requirements.
location: Princeton, New Jersey
job type: Permanent
salary: $130,000 - 150,000 per year
work hours: 8 to 5
education: Law Degree
experience: 3 Years
- Assist with the maintenance of the HCNA monitoring and auditing program
- Develop and execute healthcare compliance monitoring plans (e.g., field rides, data reviews)
- Develop and execute healthcare compliance audits to evaluate adherence to company policies, laws, and guidance
- Develop and execute healthcare compliance risk assessment and corrective action plans
- Analyze relevant corporate or field-based data to assess healthcare compliance risks
- Identify risk mitigation strategies in the area of healthcare law compliance
- Lead the identification and implementation of related monitoring and auditing tools
- Draft reports related to risk assessment, monitoring and auditing activities
- Deliver detailed and meaningful presentations (oral and written) on related monitoring, auditing, and risk assessment activities
- Assist with the development of periodic reports to relevant stakeholders
- Partner with relevant internal departments in executing collaborative monitoring, auditing, and corrective action activities related to healthcare law compliance
- Partner with Compliance Counsel in the development of healthcare law policies and procedures, as applicable to role
- Partner with Compliance Counsel and other relevant parties for investigations and healthcare compliance related inquiries
- 25% Travel required
- BS/BA degree required.
- Juris Doctorate degree is a plus.
- Certification in healthcare compliance a plus.
- Licensure or certification in auditing or accounting is a plus.
- Experience with Concur is a plus.
- 3-5 years auditing and monitoring experience and practical experience in interpretation of relevant industry regulations and guidance documents is required.
- 3-5 years broad experience in pharmaceutical industry and/or with pharmaceutical manufacturer activities is required.
- Must have knowledge of relevant healthcare laws (i.e., AKS, FCA, FDCA, FCPA, PDMA).
- Proficiency in Microsoft Office is required (i.e., Word, Excel, PowerPoint).
- Experience multi-tasking, managing multiple projects, and meeting deadlines is required.
- Must possess strong verbal and written skills.
- Must be self-motivated and possess strong interpersonal skills.
skills: Healthcare Law, Compliance Law
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.