Associate Director, U.S. Ethics & Compliance Advisor, Medical Affairs

Responsibilities

• Work with the Senior Director to provide expertise in healthcare compliance ensuring that Medical Affairs activities align with the highest ethical and compliance standards.
• Partner with leaders across Legal, Commercial, Medical, Clinical Development to build and integrate the compliance program into the US Medical Organization.
• Participate in activity reviews consistent with established policies and processes, advising on ethics and compliance insights and recommendations, including outreach to relevant stakeholders or subject matter experts when appropriate.
• Advise on and support the business and other key stakeholders in operationalizing compliance processes and executing within legal and compliance-related requirements.
• Develop and deliver trainings and educational sessions to enhance ethics and compliance understanding among stakeholders.
• Recognize healthcare compliance risks and support the identification of mitigation controls to help address, as needed.
• Partner as needed with Privacy and Data Ethics team to operationalize requirements related to data privacy, information security, cyber laws, industry codes.
• Support and facilitate policy, training and communications, monitoring, risk assessments, due diligence, transparency, and other healthcare compliance needs.
• Stay abreast of relevant ethics and compliance developments and industry trends.
• Work in partnership with the US Legal Business Partners and other Legal and/or Compliance teams to help ensure the organization operates within ethical and compliance frameworks.
• Lead, inspire, and foster a high-performance culture.

Basic Qualifications

• Bachelor's Degree and Ten Years' Experience OR Masters' Degree and Eight Years' Experience OR PhD and Two Years' Experience.
• A Juris Doctorate or fully qualified legal credentials in one or more geographies of operations is preferred but not required.
• Extensive professional experience in-house in biotech, pharmaceuticals or other highly regulated industries or law firm advising in all relevant areas of practice for these industries. Ideally the majority of the years of career spent in-house.
• 7-9+ years of Compliance experience.
• Management experience and ability to mentor and supervise a team of professionals.
• Excellent verbal and written communication skills in English.

People Leader Accountabilities

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.