Associate Director, Compliance
Vericel Corporation
6 months ago
Remote friendly (Burlington, MA)
United States
Corporate Functions
Responsibilities:
- Continue to build an effective and scalable compliance program.
- Understand healthcare compliance laws, regulations, and industry codes governing medical device, pharmaceutical and/or biologics industry business practices.
- Stay current on compliance laws/guidance, including OIG/DOJ, AdvaMed code, state/federal privacy laws, and state marketing compliance laws.
- Have in-depth knowledge of anti-kickback prohibitions and FDA rules regarding off-label promotion.
- Build credibility with senior management and operational leaders; foster a culture of trust, integrity, transparency, and openness.
- Serve as the legal representative for the Medical, Legal and Regulatory (MLR) review of promotional materials/communications.
- Coordinate and manage transparency reporting under federal and state Open Payments laws.
- Support long-term compliance program strategic planning and maintain best practices.
- Assist with compliance training (develop, launch, and monitor online and live training for Sales, Marketing, Medical Affairs, and others).
- Assist with internal investigation procedures; investigate suspected Code of Conduct/policy violations.
- Participate in audit activities, including monitoring sales activities and speaker/advisory board/sponsorship programs.
- Serve as a trusted compliance advisor to commercial and medical organizations.
- Support other legal management requests as needed, including litigation and contracting.
- Supervise external legal counsel and vendor relationships.
Qualifications:
- Bachelor’s degree or above; healthcare compliance experience, including medical device and/or biologic/pharmaceutical industries.
- 7+ years in corporate compliance within medical device/pharmaceutical/biotech industries with marketed commercial products.
- Preferred: subject-matter knowledge of healthcare compliance programs; anti-kickback rules; Open Payments/Sunshine Act; AdvaMed and/or PhRMA Code of Ethics; FDA advertising/promotion rules.
- Highly familiar with the US life science marketplace; substantive knowledge of applicable US healthcare/pharma laws; auditing experience; experience developing and implementing policies and systems (e.g., CRM, Concur, Aggregate Spend).
Benefits/Compensation:
- Salary range: $200,000 to $230,000 annually. Bonus/incentive pay, equity, and benefits may be provided in addition to base compensation.
- Continue to build an effective and scalable compliance program.
- Understand healthcare compliance laws, regulations, and industry codes governing medical device, pharmaceutical and/or biologics industry business practices.
- Stay current on compliance laws/guidance, including OIG/DOJ, AdvaMed code, state/federal privacy laws, and state marketing compliance laws.
- Have in-depth knowledge of anti-kickback prohibitions and FDA rules regarding off-label promotion.
- Build credibility with senior management and operational leaders; foster a culture of trust, integrity, transparency, and openness.
- Serve as the legal representative for the Medical, Legal and Regulatory (MLR) review of promotional materials/communications.
- Coordinate and manage transparency reporting under federal and state Open Payments laws.
- Support long-term compliance program strategic planning and maintain best practices.
- Assist with compliance training (develop, launch, and monitor online and live training for Sales, Marketing, Medical Affairs, and others).
- Assist with internal investigation procedures; investigate suspected Code of Conduct/policy violations.
- Participate in audit activities, including monitoring sales activities and speaker/advisory board/sponsorship programs.
- Serve as a trusted compliance advisor to commercial and medical organizations.
- Support other legal management requests as needed, including litigation and contracting.
- Supervise external legal counsel and vendor relationships.
Qualifications:
- Bachelor’s degree or above; healthcare compliance experience, including medical device and/or biologic/pharmaceutical industries.
- 7+ years in corporate compliance within medical device/pharmaceutical/biotech industries with marketed commercial products.
- Preferred: subject-matter knowledge of healthcare compliance programs; anti-kickback rules; Open Payments/Sunshine Act; AdvaMed and/or PhRMA Code of Ethics; FDA advertising/promotion rules.
- Highly familiar with the US life science marketplace; substantive knowledge of applicable US healthcare/pharma laws; auditing experience; experience developing and implementing policies and systems (e.g., CRM, Concur, Aggregate Spend).
Benefits/Compensation:
- Salary range: $200,000 to $230,000 annually. Bonus/incentive pay, equity, and benefits may be provided in addition to base compensation.