Assistant Director, Healthcare Compliance & Privacy Programs
Scorpion Therapeutics, Boston, Massachusetts, us, 02298
Role Summary
Reporting to the Executive Director of Compliance, the Assistant Director, Healthcare Compliance & Privacy Programs helps advance and sustain Ionis’ healthcare compliance and privacy programs through cross-functional coordination and program support. This role partners with Compliance Counsel, Compliance Operations, and the Privacy Officer, to translate legal and regulatory requirements into practical processes, tools, training, and controls that enable consistent implementation of healthcare compliance, and data protection laws. This position works closely with business teams, including Legal, IT, Commercial, Medical Affairs, and R&D to foster a strong culture of ethics and compliance. This position may be remote or based in Carlsbad, CA or Boston, MA, with expectations for regular on-site engagement consistent with Ionis’ hybrid work philosophy. Responsibilities
Partner with healthcare compliance and privacy team leads with program planning, coordination, documentation, and continuous improvement initiatives, including compliance brand management Coordinate and support privacy program activities, including Data Protection Impact Assessments (DPIAs), Records of Processing Activities (RoPAs), data mapping, maintenance of related documentation, and facilitation of data subject requests Partner with Compliance attorneys to support investigations, issue escalation, and corrective action plans, as needed Prepare and present training and guidance materials for diverse audiences in support of Compliance attorneys and functional subject matter experts Coordinate training completion tracking, training record maintenance, and updates to training content Assist with the development, maintenance, and coordination of healthcare compliance and privacy policies and procedures Support healthcare compliance risk assessments, monitoring and audit activities and remediation efforts Conduct field monitoring activities, including field rides, attendance at promotional and educational events and congresses Healthcare compliance reviewer of HCP and Patient needs assessments and external funding requests Assist with healthcare compliance and privacy metrics and reporting for Compliance leadership Monitor changes in healthcare compliance and data protection requirements and assist in operationalizing program updates Support AI-related healthcare compliance and privacy initiatives Qualifications
Required: Bachelor’s degree Preferred: Advanced degree or relevant certifications (e.g., CCEP, CIPM, CIPP, PMP) Required: Minimum of 8 years of experience in healthcare compliance, privacy, or related roles within the pharmaceutical, biotechnology, or life sciences industry, or 6 years with an advanced degree or relevant certification/s Required: Hands-on experience supporting data privacy programs, including DPIAs, RoPAs, data inventories, privacy risk assessments and data subject requests Required: Working knowledge of Privacy Technology tools such as OneTrust Required: Working knowledge of U.S. healthcare compliance laws and industry requirements, including, but not limited to, OIG and PhRMA guidelines, transparency reporting, Anti-Kickback Statute (AKS), False Claims Act (FCA), and related fraud and abuse laws Required: Ability to translate legal and regulatory requirements into practical operational processes, tools, and controls Required: Strong project and program management experience, with demonstrated ability to manage complex, cross-functional initiatives Required: Strong organizational, analytical, and problem-solving skills Required: Excellent written and verbal communication skills to clearly convey complex information to diverse audiences Required: Familiarity with AI technologies and their application in compliance programs Required: High level of integrity, discretion, and attention to detail in handling sensitive and confidential information Required: Ability to work in a fast paced and dynamic work environment with a strong work ethic and positive attitude Required: Agility to take on new projects and additional responsibilities, as required Required: Occasional domestic travel (up to 20%)
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Reporting to the Executive Director of Compliance, the Assistant Director, Healthcare Compliance & Privacy Programs helps advance and sustain Ionis’ healthcare compliance and privacy programs through cross-functional coordination and program support. This role partners with Compliance Counsel, Compliance Operations, and the Privacy Officer, to translate legal and regulatory requirements into practical processes, tools, training, and controls that enable consistent implementation of healthcare compliance, and data protection laws. This position works closely with business teams, including Legal, IT, Commercial, Medical Affairs, and R&D to foster a strong culture of ethics and compliance. This position may be remote or based in Carlsbad, CA or Boston, MA, with expectations for regular on-site engagement consistent with Ionis’ hybrid work philosophy. Responsibilities
Partner with healthcare compliance and privacy team leads with program planning, coordination, documentation, and continuous improvement initiatives, including compliance brand management Coordinate and support privacy program activities, including Data Protection Impact Assessments (DPIAs), Records of Processing Activities (RoPAs), data mapping, maintenance of related documentation, and facilitation of data subject requests Partner with Compliance attorneys to support investigations, issue escalation, and corrective action plans, as needed Prepare and present training and guidance materials for diverse audiences in support of Compliance attorneys and functional subject matter experts Coordinate training completion tracking, training record maintenance, and updates to training content Assist with the development, maintenance, and coordination of healthcare compliance and privacy policies and procedures Support healthcare compliance risk assessments, monitoring and audit activities and remediation efforts Conduct field monitoring activities, including field rides, attendance at promotional and educational events and congresses Healthcare compliance reviewer of HCP and Patient needs assessments and external funding requests Assist with healthcare compliance and privacy metrics and reporting for Compliance leadership Monitor changes in healthcare compliance and data protection requirements and assist in operationalizing program updates Support AI-related healthcare compliance and privacy initiatives Qualifications
Required: Bachelor’s degree Preferred: Advanced degree or relevant certifications (e.g., CCEP, CIPM, CIPP, PMP) Required: Minimum of 8 years of experience in healthcare compliance, privacy, or related roles within the pharmaceutical, biotechnology, or life sciences industry, or 6 years with an advanced degree or relevant certification/s Required: Hands-on experience supporting data privacy programs, including DPIAs, RoPAs, data inventories, privacy risk assessments and data subject requests Required: Working knowledge of Privacy Technology tools such as OneTrust Required: Working knowledge of U.S. healthcare compliance laws and industry requirements, including, but not limited to, OIG and PhRMA guidelines, transparency reporting, Anti-Kickback Statute (AKS), False Claims Act (FCA), and related fraud and abuse laws Required: Ability to translate legal and regulatory requirements into practical operational processes, tools, and controls Required: Strong project and program management experience, with demonstrated ability to manage complex, cross-functional initiatives Required: Strong organizational, analytical, and problem-solving skills Required: Excellent written and verbal communication skills to clearly convey complex information to diverse audiences Required: Familiarity with AI technologies and their application in compliance programs Required: High level of integrity, discretion, and attention to detail in handling sensitive and confidential information Required: Ability to work in a fast paced and dynamic work environment with a strong work ethic and positive attitude Required: Agility to take on new projects and additional responsibilities, as required Required: Occasional domestic travel (up to 20%)
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