- Lead the continued development and implementation of the US Healthcare Compliance Program, including policies, procedures, and training related to the company’s US operations.
- Partner closely with other departments, including US commercial and medical affairs leadership, providing day-to-day input and business advice related to compliance questions and continuing to grow our culture of compliance.
- Assist with the development of annual risk assessments, taking into account the external environment and company- and product-specific risks.
- Provide oversight of the US auditing, monitoring and analytics plan and help execute on designated aspects of the plan.
- Identify and implement reporting capabilities, metrics and key performance indicators that measure the effectiveness of the US compliance program.
- Conduct internal compliance investigations as necessary, either individually or working with the legal team.
- Answer Healthcare Compliance questions and promptly respond to concerns or suspected violations.
- Remain up-to-date on industry-related best practices and enforcement activities and update the compliance committee and other TESARO associates, as appropriate.
- Serve as a role model for compliance in a manner that supports the TESARO mission and core values.
Abilities Needed for Success
- Strong technical/analytical skills, combined with a practical, business-oriented approach to identifying and solving business and compliance problems.
- Proven leader, assertive, and self-confident, with the ability to act with urgency and passion.
- Entrepreneurial, enjoys working in a fast-paced, changing, small-company environment.
- Proven ability to work with a high level of integrity, accuracy, and attention to detail.
- Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete work on-time and on-budget.
- Excellent oral and written communication skills for effectively interfacing with all levels of the organization.
- Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions.
- Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships.
- Proactively seeks out and recommends process improvements.
- Resourceful, creative, enthusiastic, and results-oriented.
- 10-15 years of industry-related experience, including a minimum of 5 years in-house healthcare compliance experience within a U.S. biotech or pharmaceutical company.
- Bachelor's Degree required. J.D. or Master's degree in related areas (such as compliance, business) desirable.
- Experience managing a small team preferred.
- Expertise in the areas of corporate compliance, including state and federal laws and regulations, industry guidelines and other requirements relevant to the Company's compliance program, including fraud and abuse and anti-kickback laws, OIG and PhRMA guidelines, FDA regulations and guidance on promotion, state and federal aggregate spend reporting requirements, and corporate integrity agreements.