Posted : Saturday, March 09, 2024 05:24 AM
Short Role Description / Purpose:
The Compliance Associate Director – Market Access reports to the Commercial Compliance Director and is the primary senior Compliance professional to the (Market Access) department, which includes Program Design, Access Strategy, Access Operations, Patient Access Managers, Patient Support Programs, and Patient Support Programs vendors.
The Compliance Associate Director/Director will support the functional leadership team and be responsible for providing strategic and tactical Compliance support for all critical core Compliance Program elements, including guidance, delivering impactful, role-based training, conducting back-end and live monitoring, audit support, as well as creating compliance-related policies, procedures and resources Long Description: •Serve as the Compliance business partner and subject matter expert to the Market Access department.
•Provide guidance and education on complex Compliance issues related to payor relationships, distribution, coverage and access, price transparency, field reimbursement activities and PAP Hub services.
•Drive the development, implementation and strategic direction for Compliance strategy for Market Access function, ensuring alignment with the US Corporate Compliance strategy; and provide leadership on complex Compliance issues related to Corporate Compliance strategy and Strategic Operations' strategy, including oversight and support to ensure integration into business operations and work with key stakeholders to ensure organization initiatives are implemented •Serve on Company’s Pricing and Market Access Committee, as well as the governance committee for the Company’s reimbursement access hub •Establish and maintain dialogue with executive team and other stakeholders to effectively communicate, guide and coach on compliance program developments •Promote with stakeholders a proactive approach to Compliance that is focused on partnerships, prevention, and risk mitigation •Identify and respond to compliance issues and questions in a thoughtful, solutions-oriented and timely manner, in alignment with Compliance best practices •Drive innovative improvements through leading the development, review/update and implementation of Compliance best practices, policies and procedures applicable to Strategic Operations; create policy- and procedure-based resources; and review materials developed for the function (training materials, presentations, guides, etc.
) to ensure alignment with Compliance policies •Support and provide guidance in compliance review and approval processes related to Strategic Operations activities TRAINING, COMMUNICATION, & MONITORING/AUDIT •Develop and deliver engaging, role-specific Compliance trainings; with the ability to adapt and deliver both virtually and in-person •Communicate directly and proactively with Market Access stakeholders and cross-functional partners to support business needs and develop relationships with key stakeholders •Implement all live compliance monitoring and back-end monitoring activities along with on-going measurement, tracking and reporting for the Market Access department •Conduct and complete assigned monitoring activities.
Leverage monitoring and auditing data to identify trends to present to functional leadership, along with coaching and recommendations to address non-compliant trends (training, investigation, corrective action, etc.
) •Provide support and oversight for compliance audits occurring in the Strategic Operations department •Conduct investigations related to allegations of non-compliance related to Market Access activities •Develop, implement and maintain robust corrective action processes, as needed, in collaboration with Human Resources and Legal, to support continuous improvement and compliance policy adherence •Responsible for risk mitigation activities (Risk Assessment and Mitigation Plan - “RAMP”) associated with the Market Access department, including the creation and implementation of mitigation plans and processes •Facilitate appropriate follow-up and close-out of compliance issues per Compliance monitoring and auditing •Actively foster stakeholder engagement through meaningful and intentional cross-functional business partnerships •Raise awareness of the Compliance program and foster department and org-wide accountability for compliance in collaboration with the compliance organization.
•Maintain effective rapport with colleagues and stakeholders internally and externally.
•All other duties as assigned Education & Experience: Bachelor’s Degree in business, finance, life sciences, or healthcare 8+ years of market access, compliance, and/or related experience with a Bachelor's Degree or 4+ years of market access, compliance, and/or related experience with a JD Technical Expertise: •Related experience working in the life sciences industry (pharmaceutical, biotech, medical device, etc.
) •Ability to build and maintain professional relationships with internal stakeholders •Ability to work in a fast-paced environment while demonstrating flexibility, commitment to teamwork, and a willingness to adapt assignments to meet the Company’s needs.
•Demonstrated knowledge of regulatory/compliance requirements, including Anti-Kickback Statute, False Claims Act, government pricing regulations, and state price transparency laws and regulations •Acts with a sense of urgency, with high motivation and ability to take initiative, follow through and complete projects in a professional and expeditious manner •Strong presentation skills, including creating and delivering presentations to various size audiences at all levels of the organization •Strong analytical and problem-solving skills •Strong attention to detail and accuracy •Strong collaborative, interpersonal and oral communication skills •Excellent written communication skills, including robust and advanced documentation practices •Handles confidential matters with discretion and solid judgment.
•Produces high quality work with minimal oversight from manager $160,000 - $200,000 a year At Dompe, we offer an attractive compensation package to our team members.
Any offer would include a competitive base salary (estimate shared above), incentive bonus, and benefits package customary to the position.
Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
The Compliance Associate Director/Director will support the functional leadership team and be responsible for providing strategic and tactical Compliance support for all critical core Compliance Program elements, including guidance, delivering impactful, role-based training, conducting back-end and live monitoring, audit support, as well as creating compliance-related policies, procedures and resources Long Description: •Serve as the Compliance business partner and subject matter expert to the Market Access department.
•Provide guidance and education on complex Compliance issues related to payor relationships, distribution, coverage and access, price transparency, field reimbursement activities and PAP Hub services.
•Drive the development, implementation and strategic direction for Compliance strategy for Market Access function, ensuring alignment with the US Corporate Compliance strategy; and provide leadership on complex Compliance issues related to Corporate Compliance strategy and Strategic Operations' strategy, including oversight and support to ensure integration into business operations and work with key stakeholders to ensure organization initiatives are implemented •Serve on Company’s Pricing and Market Access Committee, as well as the governance committee for the Company’s reimbursement access hub •Establish and maintain dialogue with executive team and other stakeholders to effectively communicate, guide and coach on compliance program developments •Promote with stakeholders a proactive approach to Compliance that is focused on partnerships, prevention, and risk mitigation •Identify and respond to compliance issues and questions in a thoughtful, solutions-oriented and timely manner, in alignment with Compliance best practices •Drive innovative improvements through leading the development, review/update and implementation of Compliance best practices, policies and procedures applicable to Strategic Operations; create policy- and procedure-based resources; and review materials developed for the function (training materials, presentations, guides, etc.
) to ensure alignment with Compliance policies •Support and provide guidance in compliance review and approval processes related to Strategic Operations activities TRAINING, COMMUNICATION, & MONITORING/AUDIT •Develop and deliver engaging, role-specific Compliance trainings; with the ability to adapt and deliver both virtually and in-person •Communicate directly and proactively with Market Access stakeholders and cross-functional partners to support business needs and develop relationships with key stakeholders •Implement all live compliance monitoring and back-end monitoring activities along with on-going measurement, tracking and reporting for the Market Access department •Conduct and complete assigned monitoring activities.
Leverage monitoring and auditing data to identify trends to present to functional leadership, along with coaching and recommendations to address non-compliant trends (training, investigation, corrective action, etc.
) •Provide support and oversight for compliance audits occurring in the Strategic Operations department •Conduct investigations related to allegations of non-compliance related to Market Access activities •Develop, implement and maintain robust corrective action processes, as needed, in collaboration with Human Resources and Legal, to support continuous improvement and compliance policy adherence •Responsible for risk mitigation activities (Risk Assessment and Mitigation Plan - “RAMP”) associated with the Market Access department, including the creation and implementation of mitigation plans and processes •Facilitate appropriate follow-up and close-out of compliance issues per Compliance monitoring and auditing •Actively foster stakeholder engagement through meaningful and intentional cross-functional business partnerships •Raise awareness of the Compliance program and foster department and org-wide accountability for compliance in collaboration with the compliance organization.
•Maintain effective rapport with colleagues and stakeholders internally and externally.
•All other duties as assigned Education & Experience: Bachelor’s Degree in business, finance, life sciences, or healthcare 8+ years of market access, compliance, and/or related experience with a Bachelor's Degree or 4+ years of market access, compliance, and/or related experience with a JD Technical Expertise: •Related experience working in the life sciences industry (pharmaceutical, biotech, medical device, etc.
) •Ability to build and maintain professional relationships with internal stakeholders •Ability to work in a fast-paced environment while demonstrating flexibility, commitment to teamwork, and a willingness to adapt assignments to meet the Company’s needs.
•Demonstrated knowledge of regulatory/compliance requirements, including Anti-Kickback Statute, False Claims Act, government pricing regulations, and state price transparency laws and regulations •Acts with a sense of urgency, with high motivation and ability to take initiative, follow through and complete projects in a professional and expeditious manner •Strong presentation skills, including creating and delivering presentations to various size audiences at all levels of the organization •Strong analytical and problem-solving skills •Strong attention to detail and accuracy •Strong collaborative, interpersonal and oral communication skills •Excellent written communication skills, including robust and advanced documentation practices •Handles confidential matters with discretion and solid judgment.
•Produces high quality work with minimal oversight from manager $160,000 - $200,000 a year At Dompe, we offer an attractive compensation package to our team members.
Any offer would include a competitive base salary (estimate shared above), incentive bonus, and benefits package customary to the position.
Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
• Phone : NA
• Location : San Mateo, CA
• Post ID: 9072593709