Senior Manager Commercial Compliance
The Senior Manager Commercial Compliance will play a leadership role in developing and implementing methodologies to monitor sales and marketing promotional activities. This role will help ensure that sales related promotional spending and activities are effective, efficient and compliant with company policies and procedures, federal and state regulations (e.g., FDCA, PDMA, PhRMA, HIPAA, FCPA, etc.) and reporting requirements (aggregate spend and Sunshine Act). Additional responsibilities will include escalating potential compliance issues to other members of the Commercial Compliance Department and/or the Legal Department and assisting in the investigation as necessary.
Working with the Associate Director Commercial Compliance, this individual will create and implement new systems and processes to monitor sales and marketing promotional activities, primarily through utilization of audit command language software.
Collaborate with Sales Operations personnel and develop methodologies to monitor activities of relevant third party service providers to ensure their actions on behalf of the company are consistent with existing laws, regulations and company policies.
Perform monitoring activities of various sales and marketing promotional activities as required by the annual plan. Perform project/audit planning, develop and perform the procedures and steps for achieving compliance/audit goals, summarize and report the results to management. Escalate potential compliance issues for review and assist in the investigation as necessary.
Assist on new projects/initiatives within Sales, Marketing, and Sales Operations to ensure appropriate processes include compliance requirements and business needs. Develop monitoring tools, processes and periodic reporting of results back to key stakeholders.
Assist in the identification of compliance training needs, support development of new and enhanced compliance training programs, and conduct training of personnel on a wide variety of compliance topics.
Assist in the development of metrics and key performance indicators that reflect the effectiveness of the compliance program.
Bachelor's degree required; advanced degree desirable.
Minimum 5 years of auditing/monitoring experience, preferably in a pharmaceutical, medical device or healthcare company.
Knowledge and understanding of healthcare sales compliance requirements and the applicable legal and regulatory framework governing the sales and marketing of pharmaceutical products, including but not limited to the Anti-kickback Statute, the False Claims Act, OIG Guidelines, FDA rules and regulations.
Expertise in utilizing audit command language software to audit/analyze significant amounts of data and identify issues, determine root causes and recommend corrective action. A Certified Information Systems Auditor (CISA) or ACL Certified Data Analyst is highly preferred.
Excellent interpersonal skills and proven ability to communicate and work with all levels of the organization
Ability to organize and prioritize multiple tasks and assignments in order to meet deadlines, seeking direction as appropriate.
Warner Chilcott - 23 months ago
Warner Chilcott PLC develops and markets branded prescription pharmaceutical products in the United States. The Company's primary area of...