BeOne 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:
We are seeking an experienced biotechnology/pharmaceutical law attorney to provide legal support, counseling, and strategic guidance on commercial and regulatory matters for in North America. This role will be the lead product counsel to support one of our products.
The successful candidate will have 8+ years of commercial and regulatory legal experience representing biotechnology/pharmaceutical companies in the United States across the entire product lifecycle, from clinical development, to regulatory approval and product launch, to post-marketing activities.
This position will be located in the United States, either remote or at one of our offices in San Carlos, CA, Cambridge, MA, or Hopewell, NJ.
Essential Functions of the job:
1. Provide timely and practical advice and guidance on healthcare laws and regulations applicable to product development and commercialization in North America.
2. Acting independently, serve as the legal representative on various cross-functional teams, including promotional and medical review committees, product development teams, medical affairs and marketing teams, and senior leadership.
3. Provide advice with respect to access and reimbursement, payer communications, and patient support programs.
4. Provide proactive and strategic guidance on healthcare regulatory matters across business functions, including commercial messaging, clinical development, medical affairs communications, regulatory, and healthcare compliance.
5. Review and provide guidance on a wide range of promotional and non-promotional materials, including branded promotional materials, disease education/disease awareness campaigns, scientific communications, speaker programs, patient education materials, grants and sponsorships, sales training, and reprint and publications plans.
6. Counsel on appropriate relationships with healthcare professionals, patients, managed care entities, advocacy organizations, and government entities, consistent with relevant healthcare laws, guidance documents, and current enforcement trends.
7. Review and advise on healthcare regulatory matters related to external communications, such as scientific journal articles, abstracts, presentations at medical conferences, press releases, and investor presentations, and participate in internal and external working groups such as trade associations and government affairs activities.
8. Review and negotiate commercial agreements, including marketing, distribution and other related agreements.
9. Assist with the development and implementation of policies and procedures related to healthcare compliance, including interactions with healthcare professionals, speaker programs, patient access and reimbursement support, expanded access, advisory boards, market access, and activities at scientific congresses.
Supervisory Responsibilities:
N/A
Other Qualifications:
10. 8+ years of experience in a healthcare law role in the biotechnology/pharmaceutical industry, with significant experience supporting branded biotech/pharmaceutical product(s), including participation in promotional and medical review processes, preferably in oncology and for accelerated approval product(s).
11. Strong command of relevant healthcare laws, market access, regulations, guidance, industry codes, and enforcement trends.
12. Ability to manage and serve a wide range of client groups by recognizing and responding quickly and pragmatically to urgent situations and competing demands.
13. Exceptional and demonstrated written and verbal communication skills and interpersonal skills in both one-on-one and group settings.
14. Excellent organizational skills and problem-solving capabilities.
15. Ability to make risk-based judgements and provide clear and concise practical, solution-orientated guidance on complex matters.
16. Confidence and presence to advise clients at all levels with limited oversight.
Education Required: Juris Doctorate
Travel: Approximately 5-10%
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
17. Fosters Teamwork
18. Provides and Solicits Honest and Actionable Feedback
19. Self-Awareness
20. Acts Inclusively
21. Demonstrates Initiative
22. Entrepreneurial Mindset
23. Continuous Learning
24. Embraces Change
25. Results-Oriented
26. Analytical Thinking/Data Analysis
27. Financial Excellence
28. Communicates with Clarity
Salary Range: $174,000.00 - $224,000.00 annually
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.