Associate Director, Healthcare Compliance

We are seeking an Associate Director of Compliance to join our Compliance group.  This position will have the opportunity to provide compliance advice and support across the company, although based on experience and prior job responsibilities, this role will also have primary responsibility for defined functional areas.  This position will report to the VP, Chief Compliance Officer. This is an in-office role only.

Responsibilities

• Serve as a key subject matter expert in supporting the compliance advisory needs of the organization
• Expert understanding of the laws, regulations, industry standards, and guidelines for interactions with healthcare professionals and other Ethical codes and regulations
• Advise on appropriate compliance interactions and policy guidelines, including on topics such as fair market value, advisory board participation, speaker programs, grants and corporate contributions
• Lead the Compliance Auditing and Monitoring function, including building, conducting, and executing compliance audits or projects, and conducting in-person live monitoring of applicable areas (e.g., field rides)
• Oversee and manage the process and capture of timely, accurate and consistent data for incorporation into filings and reports related to required HCP payment disclosure, including U.S. Sunshine Act and state law reporting
• Partner with all Company internal clients to clarify and help validate data and prepare reports and filings for transparency data for final attestation by the Chief Compliance Officer
• Oversee, manage, and engage in continuous improvement, review, drafting, and project management for all Compliance-specific policies, SOPs, guidelines, and work instructions
• Manage and complete required compliance screening and other antibribery-anticorruption activities
• Serve as an accountability partner for managing, maintaining, documenting, and dispatch of all Compliance-training materials, policies, or content (including New Hire Compliance Trainings) and other Learning Management System (LMS) project management areas
• Oversee and manage the process, data capture, analytics, and report generation for compliance monitoring activities (live monitoring and process/documentation monitoring) in conjunction with the Chief Compliance Officer
• Serve as principal Compliance reviewer for the Corporate Affairs Grant Review Committee (GRC), Independent Medical Education (IME) Review Committee, and other committees as may be assigned
• Partner and collaborate, as appropriate and applicable, with Legal colleagues
• Keep apprised of applicable federal, state, and local laws, industry codes and regulations and apply them to areas of responsibility
• Experience with compliance auditing, monitoring, and compliance data systems, and privacy (CCPA and GDPR) helpful

Qualifications

• Demonstrated expertise in pharmaceutical / life science & health law compliance is required. JD degree helpful but not required. Minimum of 7-10 years of experience in biotechnology, pharmaceutical, or life science related matters.
• Detailed-oriented with a high level of intellectual, professional and interpersonal agility and flexibility.
• Solution-oriented and growth mindset in working with clients on matters of compliance and ethics in the many emerging and novel areas of pharmaceutical/life science.
• Excellent communication skills, both oral and written.
• Well-organized and hardworking, with the ability to manage numerous projects simultaneously under deadline pressure.
• Excellent analytical skills, with a strong ability to draft and review documents, analyze and provide compliance guidance, and apply policy guidance to business needs.
• Ability to form strong working relationships with all levels of management, employees, and partners while maintaining firm adherence to proper ethical and compliance standards.
• Team-oriented, sound judgment, self-motivation and willingness to take initiative.