Director, Legal & Compliance

Company: BeiGene, Ltd.
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Competencies:

Director Compliance Office Jobs in Cambridge, MA. 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:. BeiGene is seeking an experienced Director-level compliance professional to help lead the U.S. compliance program as well as support the growth of the compliance program outside of the United States and APAC. Reporting to the Assistant General Counsel, Chief Compliance Officer, this is an excellent opportunity to serve as the primary interface for a new and fast growing U.S. commercial organization to support the launch of BeiGene‘s first FDA-approved drug, Brukinsa® while at the same time contributing to the Company’s geographic expansion. The position will contribute to the development and implementation of organizational strategies, policies and practices, and work with senior Legal, Commercial, Medical, Clinical Development, Finance and HR leadership to integrate appropriate healthcare, corporate, privacy and other controls to guide the Company’s operations. The position can be located in BeiGene’s San Mateo, CA, Emeryville, CA or Cambridge, MA office locations. Responsibilities:. Support the U.S. compliance program in line with the OIG Compliance Program Guidance for Pharmaceutical Manufactures (OIG Guidance) and industry best practices.. Establish policies, procedures and systems to foster compliance with healthcare fraud and abuse, privacy, and transparency reporting laws, as well as industry codes, such as the Food, Drug and Cosmetics Act (FDCA), Federal Anti-kickback Statute, Federal False Claims Act, Health Insurance Portability and Accountability Act (HIPAA), EU General Data Protection Regulations (GDPR), U.S. Sunshine Act and state compliance laws, and U.S. PhRMA Code.. Develop and execute a comprehensive compliance training program to U.S. employees and designated third parties on applicable compliance policies, laws and regulations, including any new developments or updates that may impact the Company’s compliance program.. Provide compliance oversight and participate, as required, in review and approval processes for core Commercial and Medical activities: grants, sponsorships, speaker bureau, advisory boards and other initiatives involving interactions with healthcare professionals, healthcare organizations and patients/advocacy groups.. Conduct periodic internal reviews, risk assessments, monitoring and auditing to ensure that compliance policies and procedures function as intended and the Company identifies potential compliance risks and remediates where necessary.. Partner with internal (e.g., Legal, Compliance, Internal Audit and Human Resources) and external (e.g., outside counsel or investigators) stakeholders for the conduct and resolution of potential compliance investigations, including the management of any resulting corrective actions plans.. Institute and maintain effective compliance communication channels for the Company by promoting awareness and retention of the Code of Conduct, the use of the Compliance Helpline, as well other means for employees to report compliance-related concerns or engage with senior leadership.. Serve as primary Legal and Compliance resource for the U.S. Sales Field Organization, Field Medical Directors and Field Market Access teams.. Regularly educate and inform the Company’s senior management on matters related to the compliance program as well as relevant healthcare industry legal and compliance developments.. As needed, recruit, manage and develop Legal and Compliance team members to support the BeiGene Legal and Compliance department and team members’ goals.. Develop, manage and execute an annual U.S. Compliance Workplan, including functional objectives, strategic priorities and operating budget.. As part of a growing Legal and Compliance team, participate in various projects outside of these primary responsibilities.. Supervisory Responsibilities:. The Director, Compliance will manage the Manager, Healthcare Compliance and potentially additional headcount in the future. Further, the position will manage the delivery of services by the department’s vendors, such as external counsel and consultants.. Computer Skills:. Proficiency in the Microsoft suite of tools including Outlook, Word, PowerPoint and Excel. Other Qualifications and Experience:. Minimum of 10 years combined relevant experience and education, including in-house pharmaceutical experience developing U.S. compliance programs.. Extensive experience with compliance matters relating to the development, approval and commercialization of pharmaceutical products. Ideal candidate will have been in a U.S. compliance role at a global oncology company.. Comprehensive knowledge of U.S. healthcare fraud and abuse laws, pharmaceutical marketing, price reporting, privacy, government contracting, federal and state disclosure requirements.. Ability to apply a risk-based analysis to compliance issues and demonstrate creativity and flexibility in developing solutions that satisfy both business requirements and legal obligations.. Strong critical thinking skills, attention to detail, adaptability, communication skills and professionalism.. Ability to work in a matrix organization, collaborate with business partners, influence peers and interact with both senior management and field Sales, Medical and Market Access teams.. Ability to manage and serve a wide range of client groups by recognizing and responding quickly and pragmatically to urgent situations.. Exceptional and demonstrated written and verbal communication skills and interpersonal skills in both one-on-one and group settings, as well as proven negotiation skills.. Excellent organizational skills and problem-solving capabilities and the ability to perform in a fast-paced, high volume, deadline-driven environment.. Confidence to advise clients at all levels with little oversight.. Appropriate judgment to liaise with Legal and business colleagues and/or outside counsel as needed.. Commitment to being a team player with the desire to be helpful in other areas covered by a growing Legal and Compliance department.. Education Required:. Bachelor of Arts or Bachelor of Science required; J.D. preferred.. Travel:. Travel approximately 30%, primarily in U.S. and potentially internationally. This position requires travel to maintain a high level of visibility with U.S. field teams and Legal and Compliance presence at Company events (e.g., scientific conferences, national and regional plan of action meetings).. Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically in accordance with BeiGene’s Code of Business Conduct and Ethics, policies and procedures.. Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; 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; 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 and 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 within 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.. Get alerts to jobs like this, to your inbox.

Keywords: BeiGene, Ltd., Cambridge , Director, Legal & Compliance, Other , Cambridge, Massachusetts