Reports To: Assistant General Counsel
Bachelor of Arts or Bachelor of Science and Juris Doctorate required.
BeiGene is seeking an experienced healthcare law attorney to provide legal support, counseling and training related to the commercialization of BeiGene products in the United States. The attorney’s primary focus will be providing legal support, advice and training to the product/brand team, including Marketing, Sales and Medical Affairs. This is a director-level position and the first US product attorney role at BeiGene. The position is located in the California Bay Area and reports in to legal department headquarters in Cambridge, MA.
- Serving as the lead product attorney who advises on laws applicable to the U.S. launch of a prescription pharmaceutical product
- Serving as a member of various cross-functional teams (including promotional and medical material review committees) for BeiGene’s products and product candidates
- Reviewing and providing guidance on disease education/disease awareness campaigns and promotional marketing materials, speaker programs, press releases, grants and sponsorships, investigator sponsored studies, market planning activities, sales incentives and direction, commercial learning, medical communications, patient education materials, reprint distribution and publication plans
- Counseling on appropriate relationships with healthcare professionals, patients, managed care entities, academic institutions and government entities
- Providing guidance to Commercial and Medical Affairs functions (including senior managers) on appropriate interactions by, and allocations of responsibilities between, Commercial and Medical Affairs functions
- Advising and training on the Food, Drug and Cosmetic Act, Federal and state Anti-Kickback Statutes, False Claims Act, HHS OIG fraud and abuse, Sunshine Act/Transparency laws, product liability, privacy, HIPAA/HITECH, industry codes (e.g., PhRMA Code, ICJME and GPP standards and ACCME guidelines), and other laws and regulations applicable to pharmaceutical commercialization
- Assisting with the development, implementation and interpretation of healthcare compliance policies SOPs and programs related to healthcare compliance and FDA-regulated matters, including but not limited to interactions with healthcare professionals, speaker programs, co-pay cards, expanded access, product samples, advisory boards, market access activities, competitive intelligence and activities at scientific congresses
- Review and negotiate commercial agreements, including marketing, distribution and other related agreements
- Provide advice with respect to government pricing and reimbursement
- As part of a small, but growing, legal department, participate in various projects outside of these primary responsibilities, including contract reviews and other matters in the Legal Department
Supervisory Responsibilities: This position does not currently have managerial responsibility or budgetary discretion.
- 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.
Proficiency in the Microsoft suite of tools including Outlook, Word, PowerPoint and Excel
Other Qualifications and Experience:
- Admitted to practice law (preferably in California)
- 7-10 years combined relevant experience in an in-house legal department of a pharmaceutical or biotech company, ideally preceded by large, national law firm experienc
- Extensive experience in legal, compliance and regulatory matters relating to the approval and commercialization of pharmaceutical products. Ideal candidate will have been lead regulatory attorney in at least one US accelerated approval and product launch for an oncology product
- Comprehensive knowledge of the Anti-kickback Statute, Fraud and Abuse Laws, False Claims Act, PhRMA Code, OIG Guidelines, Food, Drug & Cosmetic Act and other applicable laws, as well as enforcement trends
- Knowledge of distribution, wholesaler, market access, patient access and applicable privacy laws and regulations
- Ability to manage and serve a wide range of client groups by recognizing and responding quickly and pragmatically to urgent situations and demanding clients
- 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
- Ability to provide clear, concise and solutions-oriented legal advice that is consistent with BeiGene policies and standards
- 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 limited or moderate oversight
- Ability to be self-sufficient, while having appropriate judgment to liaise with Legal and Compliance colleagues and/or outside counsel as needed
- Commitment to being a team player with the desire to be helpful in all areas covered by a small legal department.
Travel: Up to 10%