Compliance Sr. Director U.S. Rare Disease

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Requirements:

• Doctorate degree and 5 years of compliance, legal or a control function supporting a bio-pharmaceutical business experience
• Or Master’s degree and 8 years of compliance, legal or a control function supporting a bio-pharmaceutical business experience
• Or Bachelor’s degree and 10 years of compliance, legal or a control function supporting a bio-pharmaceutical business experience
• five years of experience with buy-and-bill and/or patient support services model
• Prior experience as the lead strategic compliance or legal advisor for a bio-pharmaceutical medicine
• Deep understanding of the biotechnology industry and healthcare compliance environment (US required, plus additional major markets preferred)
• Experience navigating drug approvals, data milestones and regulatory decisions
• Demonstrated skills in delivering strategies and results in a complex organization
• Ability to prioritize resources and effectively communicate with leadership
• Strong written, spoken and interpersonal communication skills with attention to detail; polished, poised presenter
• An exceptional team leadership and talent development track record
• Strong critical thinking, problem-solving and planning skills
• Collaboratively work with a diverse group of people and backgrounds

Responsibilities:

• Drive solutions that empower our colleagues to elevate ethical decision-making and honorably secure patient access for our current and future patients
• Proactively support and anticipate business needs by embedding in both the senior leadership team and their individual leadership teams
• Develop multi-dimensional compliance strategies tailored to the unique circumstances and needs of each RDBU business that incorporate learnings from monitoring, investigations, business engagement and industry actions
• Harness purposeful relationship building and develop trust to engender buy-in with leaders by developing rapport, participating, listening and learning
• Possess unique understanding of the rare landscape and regulatory environment to thoughtfully and open-mindedly advise the Rare Disease Business Unit
• Lead and develop a team of compliance officers to elevate the support of the business
• Embrace ambiguity and adeptly navigate the evolving risk paradigm with agility, confidence and intentionality
• Influence within WC&BE and across RDBU and cross-functional partners to facilitate collaborative decision-making that elevates and ethically meets patient needs
• Confidently problem-solve, including knowing when to escalate potential challenges, and quickly learn how to work within a matrixed organization
• Be prepared to travel to major conferences, internal trainings and meetings for WC&BE or RDBU, as well as to Amgen sites in the U.S. or globally