PURPOSE: The Compliance & Legal Director ensures that our client operates within the bounds of all relevant laws and regulations concerning the medical field, alongside professional, external, and internal standards following established business practices. This role leads and oversees all regulatory and compliance processes, collaborating with internal and external stakeholders, and providing strategic guidance on initiatives and procedures with compliance implications.
GENERAL RESPONSIBILITIES:
- Establishing, cultivating, and upholding policies, training modules, and processes encompassing diverse areas such as Antikickback Law, Sunshine Act, HIPPA, Advamed Code of Ethics, SOX, various forms of Harassment, Data Protection and Conflicts of Interest.
- Conducting ongoing evaluations of materials, policies, and strategies concerning relevant regulations and standards, including training materials for both field and non-field staff.
- Collaborating with company leadership to formulate, track, and evaluate compliance objectives and milestones.
- Ensuring alignment of critical business processes with regulatory requirements.
- Identifying compliance deficiencies and collaborating with management to rectify them using industry best practices.
- Conducting annual reviews and audits of crucial business operations to assess compliance status and produce comprehensive reports reflecting our client's compliance initiatives.
- Spearheading the compliance investigation process and maintaining a registry of compliance incidents.
- Monitoring legislative developments to remain informed of changes and implementing necessary adjustments across the organization.
- Reviewing and crafting contractual agreements, assessing risks, and raising concerns as needed to safeguard the company's interests.
- Coordinating legal proceedings and strategies with external legal counsel and law firms when warranted.
SKILL AND EDUCATION REQUIREMENTS:
- Bachelor’s Degree required preferably in Law or related study area; legal advanced degree and/or lawyer qualified to practice in the state of Indiana is a plus
- Minimum of 8 years' experience in compliance roles within corporate settings or law firms is preferred.
- Minimum of 5 years' experience in a highly regulated environment, preferably in the healthcare or related sectors.
- Proficient understanding of laws, regulations, and standards relevant to the healthcare and medical device industries, including those pertaining to sales and marketing, privacy, and anti-corruption.
- Experience in contract preparation, analysis, and review.
- Exceptional verbal and written communication abilities.
- Proficiency in Microsoft Office applications, including Word, Excel, and Outlook.
- Certification in compliance practices is desirable.