Associate Director / Director, Compliance & Legal
The Associate Director/Director of Compliance & Legal will contribute to the development and implementation of compliance policies and practices, and work with senior Legal, Commercial, Medical, Clinical Development, Finance and HR leadership to integrate, support and monitor appropriate healthcare, corporate, privacy and other controls to guide the Company's operations. While the position is primarily a Compliance role, the ideal candidate would be able to contribute to legal matters such as contract drafting and negotiation as well as other key initiatives and projects. This position reports to the Vice President, Compliance and Legal.
Requirements:
- Assist in the implementation and management of compliance program and operations, including providing compliance oversight and participating, as required, in promotional review, review, approval and documentation processes for core Commercial and Medical activities: speaker bureau, advisory boards and other initiatives involving interactions with healthcare professionals, healthcare organizations.
- Support the ongoing compliance program by auditing and monitoring business activities, implementing process and system enhancements, and supporting remediation activities, as necessary
- Manage the transparency reporting program, including developing, reviewing, and submitting reports related to federal and state transparency ("Sunshine") laws.
- Monitor the business activities and industry compliance best practices to evolve the compliance program through ensuring appropriate practices, processes, systems and tools are in place and maintained to support the business at all times.
- Assist in providing compliance education, including both new hire, and ongoing training and be an ambassador for communication around key compliance topics, resources, and special initiatives
- Assist Finance/HR in preparing confidential reports
- Assist in preparing and reviewing legal contracts and maintenance of same, including agreements with healthcare providers and conducting debarment and exclusion checks
- Assist Market Access in facilitating state virtual manufacturing licensing activities.