ImpactBio | Head of Compliance | harrison, ny

Head of Compliance Are you a hands-on Compliance Leader ready to make an impact? We're looking for a dynamic professional who thrives in an entrepreneurial setting. This is a unique opportunity to take ownership, develop and lead Compliance functions, and contribute to a Patient-First, Team-Oriented organization . ImpactBio is proud to support Milestone Pharmaceuticals with their recruitment efforts. The Head of Compliance is a Full-Time position with ImpactBio with the opportunity to transition to Milestone Pharmaceuticals headcount upon product approval in March 2025. The ideal candidate is based on the East Coast with the ability to commute to the Milestone Pharmaceuticals Headquarters in Charlotte, NC. The Head of Compliance will be responsible for leading the design, implementation, and continuous enhancement of MIST's Healthcare Compliance Program. This position plays a critical role in managing compliance risks throughout the commercial lifecycle of MIST's products. Go to to view the job and apply. Milestone Pharmaceuticals: We are patient focused. We understand that developing an investigational therapy and having the opportunity to improve patients' lives comes with great responsibility. We feel privileged to accept that responsibility, which fuels our passion and motivation to make a difference for patients and their families. We are a team. Everything we achieve is the result of collaboration. We support, challenge, and rely on each other, have fun together, and continually seek to improve collectively. We are professionals. We are quality- and results-driven, striving to work smarter. We know inventing, developing, and commercializing a new therapy is complex. We relish the challenge, understanding that our team strength will enable Milestone to succeed. Primary Duties and Responsibilities: Lead the design, implementation, and enhancement of MIST's Healthcare Compliance Program to align with regulatory expectations, industry best practices, and organizational priorities. Develop and implement the integration of compliance elements, including policies, procedures, training, monitoring, and auditing, across the organization's operations. Serve as a strategic advisor to senior leadership, providing updates on compliance risks, program performance, and emerging regulatory trends. Facilitate cross-functional collaboration with Legal, Regulatory Affairs, Commercial, and Medical departments to ensure cohesive compliance efforts. Design and deliver role-specific compliance training programs addressing federal and state healthcare laws, anti-bribery/anti-corruption laws (e.g., FCPA, UK Bribery Act), and privacy laws (e.g., GDPR, U.S. state laws). Ensure onboarding of new employees includes comprehensive compliance education (to include code of conduct and policies), tracking participation and effectiveness. Develop and oversee a risk-based monitoring and auditing program focusing on high-risk areas such as promotional practices, field activities, speaker programs, aggregate spend reporting, advisory boards, promotional materials review procedures, trade shows, national sales meetings, donations, grants and sponsorship's. Regularly evaluate outcomes of monitoring and auditing activities to identify trends and implement risk mitigation strategies or action plans to manage compliance risks. Conduct periodic risk assessments to identify and prioritize compliance risk areas, ensuring appropriate resource allocation. Develop and implement a robust third-party risk management framework, monitoring, and training of vendors, contractors, and other external partners. Ensure third-party compliance with anti-bribery/anti-corruption, privacy, and transparency requirements. Manage investigations into potential violations of MIST policies or regulations, coordinating with the Senior Vice President of Regulatory Affairs, Quality, and Pharmacovigilance. Oversee documentation and implementation of corrective actions to address compliance issues. Other responsibilities as outlined in job description. Required Qualifications and Skills: JD degree from an accredited U.S. law school A minimum of 10 years of experience in a compliance role within the pharmaceutical, biotechnology, or medical device industry, with demonstrable success in building, operationalizing, and enhancing compliance programs. Extensive knowledge of laws, regulations, and industry standards, including the False Claims Act, Anti-Kickback Statute, PhRMA Code, FDA rules, FTC rules, Open Payments, FCPA, GDPR, and U.S. state privacy laws. Ability to handle multiple responsibilities simultaneously and meet high quality and timeliness standards under pressure. Sound judgment and commitment to ethical conduct. Proven experience in monitoring and auditing compliance activities, with a focus on promotional practices, field force activities, and transparency reporting. Demonstrated ability to design and deliver compliance training programs and assess their effectiveness. Strong interpersonal and communication skills, including the ability to influence cross-functional teams and present compliance risks and solutions to senior leadership. A collaborative and team-oriented approach to problem-solving, with the ability to work in a fast-paced, rapidly changing environment. Demonstrated ability to: understand and digest complex scenarios to identify relevant issues and risks; propose solutions that take into consideration the relevant business objectives; and communicate those issues, risks, and solutions clearly and concisely. Global mindset with the ability to navigate diverse cultural and regulatory environments. Milestone Pharmaceutical Overview: Milestone Pharmaceuticals is a patient-centric, clinical-stage biopharmaceutical company. Over the past decade, Milestone has assembled a panel of leading pharmaceutical executives with many years of experience in drug research and development. Since our founding, our unwavering focus has been on developing treatment solutions based on clinically validated mechanisms of action that can be self-administered by the patient. To learn more about Milestone Pharmaceuticals visit, About ImpactBio : ImpactBio is a trusted partner in the Life Sciences Industry that delivers Commercial and Clinical teams to help our clients Launch and Scale. We do things differently and it shows - the kudos we receive from our employees, our clients, and the HCPS & patients we serve are a testament to our work ethic and our dedication. Go to to view the job and apply ImpactBio is an equal opportunity employer M/F/V/D. We appreciate your interest in our company; however, only qualified candidates will be considered. Go to to view the job and apply

Created: 2024-11-26