Director, Healthcare Compliance (Global)
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together. Opportunity Overview
Rhythm seeks an experienced and highly motivated healthcare compliance leader with a strong life sciences background to join the Legal & Compliance Department in our Boston office. This is a global role that will provide the opportunity to work closely with the U.S. and International businesses and contribute to enhancing an existing healthcare compliance infrastructure. The ideal candidate will be energized by the pace and complexity of a rapidly growing global biotechnology company, and will excel at building relationships, driving cross-functional collaboration, and inspiring others to uphold the highest standards of compliance and integrity. This position will report to the Senior Legal Counsel in the US. The Director, Healthcare Compliance will collaborate with diverse business stakeholders within the North America and International businesses and engage with external counsel and other external advisors. Responsibilities and Duties
- Build, implement and further enhance Rhythm’s healthcare compliance program in accordance with government/regulator guidance, including HHS/OIG and DOJ guidelines and applicable EMA, MHRA and other global guidelines or requirements.
- Assist in development, implementation, and oversight of healthcare compliance policies and procedures to foster compliance with applicable laws and regulations.
- Oversee processes and systems for international, federal and state transparency (Sunshine Act and similar state requirements) aggregate spend reporting.
- Develop and implement a risk-based compliance audit and monitoring plan for US and international operations to confirm alignment with local laws and company policies.
- Manage and oversee processes and systems for third party engagements using applicable healthcare compliance technology systems
- Support the Legal & Compliance department’s ongoing efforts to use data, technology and analytics to monitor for compliance and enhance issue identification and remediation.
- Integrate global data privacy requirements, including GDPR and other relevant regulations, into healthcare compliance activities and processes. Collaborate with internal stakeholders to address privacy considerations and support responsible data handling across the organization.
- Develop, conduct, and track completion of healthcare compliance training.
- Maintain awareness of applicable laws, rules and regulations and stay apprised of changes that may affect Rhythm’s business operations and healthcare compliance program. Keep up-to-date on best practices in healthcare compliance.
- Champion company culture in which employees view compliance as aligned with core values and regard it as a key objective in business decisions and process development.
- Partner with Legal and Compliance colleagues to ensure consistency in approach across the global organization.
- Manage outside counsel as needed in connection with executing above responsibilities and duties.
- 10+ years of healthcare compliance experience in a global biotech/pharma organization. Experience with rare diseases and international regulatory environments preferred
- B.A./B.S. degree required.
- Broad understanding of the life sciences industry and the evolving regulatory landscape, including the laws, regulations, and industry guidance that affect biopharmaceutical companies including global aggregate spend and other reporting/sunshine laws, fraud and abuse and anti-kickback statutes, FDA, OIG/HHS, DOJ and PhRMA requirements, Foreign Corrupt Practices Act and anti-bribery and anti-corruption laws, data privacy laws and regulations (including HIPAA and GDPR), government enforcement actions, and U.S. state compliance requirements.
- Outstanding communication skills, with strong ability to communicate across various functions and communicate compliance risks clearly and effectively.
- Ability to use data to analyze information for healthcare compliance purposes.
- Ability to be a solutions-oriented collaborator (yet take a firm stand where necessary) with excellent judgment and interpersonal skills.
- Exceptional written, organization, and presentation skills.
- Demonstrable experience taking ownership of issues and providing timely, actionable and practical advice.
- Ability to work independently and prioritize multiple demands, including a diverse mix of issues and responsibilities, in a fast-paced environment.
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism. At Rhythm our core values are:
- We are committed to advancing scientific understanding to improve patients’ lives
- We are inspired to tackle tough challenges and have the courage to ask bold questions
- We are eager to learn and adapt
- We believe collaboration and ownership are foundational for our success
- We value the unique contribution each individual brings to furthering our mission
Headquartered in Boston, Rhythm is proud to have been named one of the in Massachusetts.
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