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Health Care Attorney in Northbrook, IL

Astellas Us, LLC Jun 06,2017 Apr 18,2017 Location Northbrook IL
This job is expired...

In-House

Attorney

Health Care

Litigation - Whistleblower - CFTC

Min 10 yrs required

Profile

Senior Director Healthcare Compliance Americas The candidate will develop the strategy and is accountable and responsible for leading the healthcare compliance program for non-commercial functions (DDR, Development, Medical Affairs, QA, PV, CRQA, RA) in the Americas and part of global matrix support for these functions in close collaboration with the Executive Director, Healthcare Compliance, Monitoring & Investigations, Americas. Develop the strategy for and leads the healthcare compliance program for the US research organizations. Will be responsible for developing global strategy for the design and implementation of a unified system for review and approval of interactions with HCPs/HCOs. Effectively implement the global and Americas-specific compliance standards through strategic planning, oversight and effective communication, training and monitoring of policies, controls and initiatives across non-commercial functions in the Americas. Develop strategy for, oversee and lead healthcare compliance projects/initiatives for non-commercial functions in the Americas in alignment with a global ethics and compliance focus and interacts closely with local, regional and global Ethics & Compliance teams to ensure adherence to laws, regulations, industry codes, policies, processes and to promote best practices. Develop strategy for and leads the continuous assessment and enhancement of the healthcare compliance program for non-commercial functions in the Americas in collaboration with business stakeholders, and makes recommendations to regional and global Ethics & Compliance leaders for opportunities for enhancement. Develop and lead strategies to ensure adherence to Company policies relating to non-commercial healthcare compliance at the regional and local level. Responsible for developing a team of non-commercial Healthcare Compliance experts across the Americas region. Develop strategies for and leads implementation of strategies to continually enhance and maintain a highly ethical, compliant and accountable culture. Lead the provision of ethics and compliance guidance for key strategic business teams/initiatives. Regularly meets with senior business leaders and participates in and provides advice for strategic business projects/initiatives. Member of Medical Affairs Americas leadership team where this Senior Director provides ethics and compliance advice about Medical Affairs strategy and initiatives on a regional and local level. Coordinate and collaborate closely with the Commercial Healthcare Compliance team in order to develop strategies for effective integrated healthcare compliance program in the region and at a local level consistent with global strategies/policies/processes; ensures that the ethics and compliance support is well coordinated, responsive to the business and in adherence with the Company's highest ethical and compliance standards. Develop strategies for and ensures effective implementation, maintenance and continuous enhancements of controls (processes and systems) relating to the review and approval of interactions with HCPs and/or HCOs. Also ensures the efficient and effective implementation and review of exclusion and debarment screening and fair market value processes in the region. Responsible for developing the strategy for, design and global implementation of one system for review and approval of interactions with HCPs/HCOs in coordination with key Ethics & Compliance, IS and business teams in each region. Develop strategy for and leads collaboration with business partners on non-commercial healthcare compliance matters in the Americas. Responsible for due diligence and integration of merged, acquired or collaboration partner entities. Collaborate with local and regional monitoring teams to share insights, observations and knowledge of ongoing and developing business strategies in order to ensure learnings are incorporated into the monitoring activities at the local and regional level and to ensure that any corrective actions and/or enhancements are tailored to ensure highly ethical and compliant business conduct. Collaborate with cross-functional teams locally, regionally and globally to influence the Healthcare Compliance strategy to ensure alignment with Americas region and support development and expertise within Ethics & Compliance. Research, benchmark and stay current with applicable legal and regulatory developments, industry standards and the changing healthcare landscape to determine emerging compliance trends and incorporates such developments, standards and trends into education for the non-commercial healthcare compliance team at the regional and local level as well as the compliance strategies and advice provided to the business. Coordinate and collaborate with the local, regional and global operations teams with respect to the auditing, monitoring, training and communications needs of the business, including proactively identifying such needs and opportunities for enhancement, and developing and implementing appropriate training and education programs. Develop and implement strategies for and leads collaboration with the non-commercial business to embed a culture of compliance, accountability and consequence for non-compliance. Responsible for operating within the regional compliance budget, and any applicable project specific budgets. Directly reports to the Executive Director, Healthcare Compliance, Monitoring & Investigations, Americas. Work closely and collaborates with Ethics & Compliance global and regional leadership, operations and Anti-bribery and Anti-corruption lead. Collaborate with approved team members via matrix global organization and manages at least four direct reports, including at least 1 Director. Lead and ensure the effective implementation of the Healthcare Compliance program in the Americas and closely coordinates with Ethics & Compliance countrparts across the globe. Work closely and collaborates with senior leadership of all functions across Americas. Advanced degree (Juris doctor; Masters; Ph.D) or advanced compliance certifications (CCEP or equivalent) and 10+ years experience in Compliance or related functions (e.g., regulatory, legal, audit, or risk) required. Expertise in compliance with law, regulations and industry codes relevant to the pharmaceutical industry and significant knowledge of the best practices relating to compliance in highly regulated industries required. Excellent project management skills required. Excellent written and verbal executive-level communication skills required. Experience working globally preferred. Fluency in spoken and written Spanish and/or Portugese preferred.

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