Emeryville, CA, 94662, USA
7 days ago
Associate Director, Compliance Policies and Projects
**General Description:** BeiGene is actively seeking a seasoned compliance professional at the associate director level who thrives in fast-paced settings, brings a proactive, pragmatic approach to compliance, and is driven to make an impact. This role will report to the Senior Director of Compliance Operations and will play a critical role in BeiGene’s global Compliance team. In this role, you will partner with colleagues across the business functions, Compliance and Legal to develop and align on a risk-based approach to healthcare compliance policy development and propagation. You will be responsible for strategically designing, developing, implementing, and managing an ethics and compliance training program that educates, engages, and motivates employees to support a culture of compliance. In addition, you will also be responsible for managing various global compliance projects that support our commitment to integrity and ethical practices. This position will be in the United States, either remote or at BeiGene’s offices in Emeryville, CA, San Mateo, CA, or Cambridge, MA. **Essential Functions of the job:** + Draft and/or oversee the drafting of global compliance policies; recommend and/or decide upon global ethics & healthcare compliance policy positions; and respond to requests for policy interpretation. + Stay current on changes in the external global ethics & healthcare compliance business environment and develop and implement policy enhancements to reflect the risks. + Design, develop, implement, and manage a comprehensive compliance training strategy that aligns with the overall global compliance program and engages employees at all levels to support a culture of compliance. + Design and deliver creative, engaging, and impactful training materials and programs, utilizing a variety of formats. + Measure and monitor employee retention, understanding, and experience with compliance trainings refining methods and content as necessary to improve overall effectiveness. + Ensure training is timely, current, and relevant to employees across the organization based on changes to legal and compliance program guidelines and applicable laws, regulations, and trends. + Develop and track training metrics and prepare reports showing the performance and on-time completion of training activities. + Work with compliance leadership to identify and plan key global initiatives to further enhance our global compliance program. + Perform project management responsibilities to deliver key global compliance initiatives, ensure on-time and on-budget delivery. + Collaborate with colleagues and vendors as necessary to deliver on key compliance projects. + Support regional compliance teams with ad hoc projects as required. + Partner with compliance auditing and monitoring team to support live and virtual monitoring activities. + Assist with ad-hoc compliance reviews, inquiries, and investigations as required. + Manage compliance technology platforms, including training, running reports, end-user support, and implement system changes to support compliance initiatives. + Support global transparency reporting work, including advising on global regulation changes, implement processes for collecting and reporting data, reviewing reports prior to submission, and advising on transparency related inquiries. **Required Qualifications:** + Bachelor of Arts or Bachelor of Science required; J.D. or other advanced degree preferred but not required. + Minimum of eight years of combined experience in healthcare compliance, including in-house experience. + Minimum of three years of project management experience. + Strong expertise in compliance with laws, regulations, and industry codes relevant to the development and commercialization of pharmaceutical products. + Working knowledge and experience with U.S. healthcare fraud and abuse laws (e.g., Anti-kickback statute, False Claims Act), FDCA, FDA guidance, OIG Compliance Program Guidance, OIG advisory opinions, and federal and state transparency and compliance program disclosure laws, and U.S. and international industry codes (e.g., PhRMA, EFPIA, IFPMA). + Excellent communication skills (oral and written; strong interpersonal skills in both one-on-one and group settings. + 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. **Other Qualifications:** + Ability to work effectively in a global environment and good at managing work under a matrix organization structure and comparably complicated environment. + Management experience and ability to lead a team of professionals without direct reporting responsibility. **Computer Skills:** + Proficiency in the Microsoft suite of tools including Outlook, Word, PowerPoint and Excel. **Supervisory Responsibilities:** + N/A **Travel:** + Travel approximately 20% + Able to travel within the region or internationally as required. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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