What are the responsibilities and job description for the Senior Director, Compliance position at Meet Life Sciences?
Overview :
Meet is partnered with a leading clinical-stage biopharmaceutical company focused on rare diseases. The organization is dedicated to delivering meaningful outcomes for patients, fostering a collaborative and values-driven environment.
3-4 days in-person per week.
Responsibilities :
- Serve as a key subject matter expert to support the compliance needs of the Commercial, Clinical, Medical Affairs, and Regulatory functions.
- Implement and maintain policies related to healthcare corporate compliance, sales and marketing compliance, privacy compliance, and data governance.
- Assist with marketing strategies, manage contracting arrangements with healthcare professionals (HCPs), evaluate promotional and non-promotional practices, and manage the process for capturing data for regulatory filings related to HCP payment disclosure, including compliance with the U.S. Sunshine Act and state law reporting.
- Provide guidance across commercial and medical affairs on interactions with patients and HCPs, including fair market value assessments, advisory board participation, and speaker programs.
- Advise on U.S. advertising and promotion laws, acting as brand counsel to support sales, marketing, and medical affairs functions.
- Monitor the regulatory, legislative, and enforcement landscape to guide internal practices and policies.
- Develop and track internal training programs and monitor compliance with applicable policies.
- Serve on various committees, including the promotional review committee, medical review committee, compliance committee, and others as assigned.
- Implement privacy controls and data strategy, ensuring compliance with GDPR, HIPAA, and other relevant data privacy regulations. Provide regulatory guidance to current business processes, new product development, research collaborations, and commercial partnerships.
Qualifications :
Law degree from an accredited U.S. law school.
10 years of compliance and privacy experience in-house within the biotech, pharmaceutical, or life sciences industry, relevant law firm experience, and / or government experience.
Comprehensive knowledge of the laws, regulations, industry standards, and ethical guidelines for interactions with HCPs and other applicable regulatory frameworks.
Self-directed and eager to be part of a small team within a high-growth, transformational company. The role will not initially have any direct reports.
Please note that we cannot support visa transfers at this time.
