Specialist / Manager, Healthcare Compliance

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
The Specialist / Manager, Healthcare Compliance will support the design, development and implementation of BeiGene’s Global Healthcare Compliance Program with special focus on the Company’s U.S., and European and new markets operations.
Reporting to the Associate Director, Healthcare Compliance, this newly created position of Specialist / Manager, Healthcare Compliance will support the Healthcare Compliance Team with the Company’s development and oversight of healthcare compliance policies, procedures, training programs and technology solutions. In addition, this role will support the Legal and Compliance Team with other features of the healthcare compliance program, including risk assessments, auditing and monitoring, investigations and the day-to-day oversight of technology solutions and tools.
The position may be based in BeiGene’s California (San Mateo or Emeryville) or Massachusetts (Cambridge) office locations.
Essential Functions of the job:
Keep abreast of compliance trends and provide practical business solutions that maintain the Company’s compliance within an evolving legal landscape.
Provide support on policy and procedure implementation governing business operations, ensuring compliance with laws and regulations applicable to the Company.
Support the development and periodic review of compliance training programs for new and existing employees to ensure a thorough understanding and appreciation of the laws that impact the Company’s operations and how to conduct business practices appropriately.
Collaborate with Procurement, Finance, IT and other functions in the design and implementation of a comprehensive third-party risk management program, including but not limited to vendor diligence screening, vendor training and distributor audits.
Manage internal policies, procedures, and compliance lines of communication, including the ethics hotline; the Company’s Compliance email inbox; and the compliance portions of the Legal and Compliance intranet page.
Oversee the functionality of Healthcare Compliance tools and technology.
Assist with federal and state Sunshine Act and corresponding foreign reporting and healthcare compliance requirements.
Assist with the creation and maintenance of Legal and Compliance-related dashboards and reports and assist with the development, management and reporting of data analytics to manage compliance risks.
Collaborate with colleagues in Compliance, Legal, Internal Audit, HR, Finance and other core control functions to develop programmatic responses to compliance issues as well as work towards future improvements as the Compliance Program evolves.
Provide timely guidance on compliance matters and inquiries relating to common HCP interactions, such as advisory boards, consulting engagements, speaker programs, sponsorships and grants .
Support the design, implementation and execution of compliance monitoring and audit programs based on Legal and Compliance policy requirements, industry risk areas and trends and incorporate feedback and observations into existing or new policies and procedures where appropriate.
Requirements:
Bachelor’s Degree (life sciences, law, public policy, marketing, business, education, or related discipline preferred)
A minimum of 3-5 years of experience working in the bio-pharmaceutical industry and/or a nationally recognized law firm or consulting practice.
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).
Experience and expertise in project management and data and technology tools.
Experience supporting the design, build, and implementation of a successful compliance program in a start-up, fast-paced, biotechnology or pharmaceutical company environment
Excellent written / verbal communication skills and presentation and project management skills.
Demonstrated ability to build solid relationships / make connections across the organization.
Ability to work independently as well as collaboratively with enthusiasm and accountability.
“Customer First” customer service orientation - puts the customer at the center of all business activities.
Education Required:
Bachelor’s degree with 3-5 years of healthcare compliance experience
Computer Skills: PC, including MS Office Suite
Travel: 10%
Competencies:
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management - Communicates changes and progress; Completes projects on time and budget.
We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

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