div>Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
We are seeking a strategic, enterprise-minded Senior Director, Healthcare Compliance reporting to VP, Head of Compliance to serve as the primary Compliance & Ethics business partner to our Commercial organization and key external-facing functions (Medical Affairs, Patient Services, and Patient Advocacy).
Lexington, Massachusetts15 days ago
div>Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
Kiniksa Pharmaceuticals is a commercial‑stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications.
Informing, reviewing and providing clear communication to all key stakeholders in both Promotional Review Committee (PRC) and Medical Review Committee (MRC) on planned label updates and how they may impact promotional and medical materials; provide key stakeholders with specific guidance on appropriate implementation of the label update, including ISI updates, for assigned therapeutic area in a timely manner. Serving as primary contact for communications with the Office of Prescription Drug Promotion (OPDP) and/or Advertising and Promotional Labeling Branch (APLB) for assigned products, including responsibilities for the timely preparation and submission of promotional materials under cover of FDA Form 2253.
Success requires leadership beyond traditional system management-delivering value from systems by translating compliance requirements into efficient, practical, and scalable solutions that enable the business to operate effectively and transparently while maintaining a strong compliance posture. The Role:
The Director, Quality Systems and Compliance provides strategic direction and oversight of Quality Systems, Compliance, and Business System Ownership to ensure execution meets regulatory requirements, industry best practices, and modern digital, data-driven expectations.
Merrimack, New Hampshire10 days ago
p>Please be advised that Fidelity’s business is governed by the provisions of the Securities Exchange Act of 1934, the Investment Advisers Act of 1940, the Investment Company Act of 1940, ERISA, numerous state laws governing securities, investment and retirement-related financial activities and the rules and regulations of numerous self-regulatory organizations, including FINRA, among others. Experience and technical expertise with practices that pertain to the asset management industry, including investment processes, derivatives and other instrument types, disclosure practices, trading and allocation issues, fund treasury and accounting matters, transfer agent, distribution, and custodial practices.
Lexington, MA30+ days ago
This role leads key quality systems including supplier oversight, product complaints, and inspection readiness, and partners cross-functionally to drive a proactive, risk-based quality culture that supports development through commercialization. The Senior Director, Quality Compliance is responsible for providing strategic leadership and oversight of the organization's global quality compliance programs, ensuring alignment with regulatory requirements and industry best practices.