Commercial and Regulatory Counsel, North America

BeiGeneSan mateo, CaliforniaFull TimeRemote


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.

About BeiGene
BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. Currently employees are located in APAC, Americas, and Europe. BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients.
 
At BeiGene, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things.
  • Patients First
  • Bold Ingenuity
  • Collaborative Spirit
  • Driving Excellence
 
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.
 
For more information, please visit our website at
www.beigene.com
 
General Description:
BeiGene is seeking an experienced biotechnology/pharmaceutical law attorney to provide legal support, counseling, and strategic guidance on commercial and regulatory matters for BeiGene’s medicines and product candidates in North America. This role will be our lead “product attorney” and support our commercial, medical affairs, regulatory, healthcare compliance and other business functions in the United States and Canada. This role will also be expected to work closely with our in-house commercial and regulatory attorneys in Europe and APAC to ensure global coordination of legal services, including product labeling, product teams, marketing, medical affairs, patient safety, and regulatory.
 
The successful candidate will have 5-10 years of commercial and regulatory 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 provides an excellent opportunity for an experienced attorney to join a growing and dynamic Legal and Compliance team and to have a key role in BeiGene’s global growth and expansion.
 
Reporting to the Senior Director, Healthcare Compliance Counsel, this position will be at the Associate Director or Director-level, depending on experience, and will be located in our San Mateo, CA office, with flexible work arrangements available.
 
Responsibilities:
  • Provide advice and guidance on healthcare laws and regulations applicable to the development and commercialization of BeiGene’s medicines and product candidates in North America.
  • Serve as the lead “product” attorney and lead legal representative on various cross-functional teams, including promotional and medical review committees.
  • Collaborate and participate on cross-functional teams for product labeling, product development teams, medical affairs, and marketing.
  • Provide advice with respect to pricing and reimbursement, sales incentive compensation, and other programs.
  • Provide advice on healthcare regulatory matters across business functions, including commercial, clinical development, medical affairs, patient safety, regulatory, and healthcare compliance.
  • 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, training materials, and reprint and publications plans.
  • 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.
  • Support market access activities, including pricing committee, government price reporting and price transparency laws, patient support programs, supply chain and distribution, patient hubs, and other complex pricing and reimbursement strategies (e.g., value-based contracting).
  • Review and advise on healthcare regulatory matters in BeiGene’s 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 the BIO trade association and government affairs activities.
  • Review and negotiate commercial agreements, including marketing, distribution and other related agreements.
  • Providing guidance on appropriate interactions by, and allocations of responsibilities between, Commercial and Medical Affairs functions.
  • Advise and train on the Food, Drug and Cosmetic Act, federal and state anti-kickback and
  • false claims statutes, OIG advisory opinions and fraud alerts, FDA guidance documents, product liability laws, privacy laws, industry codes and standards (e.g., PhRMA, ICMJE, ACCME), and other laws and regulations applicable to the development and commercialization of pharmaceutical products.
  • 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.
Requirements:
  • Juris Doctor from an accredited U.S. law school; admitted to practice in California preferred (or eligible for resident in-house counsel status)
  • At least 5-10 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).
  • Strong command of relevant healthcare laws, regulations, guidance, industry codes, and enforcement trends.
  • Ability to manage and serve a wide range of client groups by recognizing and responding quickly and pragmatically to urgent situations and competing demands.
  • Exceptional and demonstrated written and verbal communication skills and interpersonal skills in both one-on-one and group settings.
  • Excellent organizational skills and problem-solving capabilities.
  • Ability to make risk-based judgements and provide clear and concise practical, solution-orientated guidance on complex matters.
  • Confidence and presence to advise clients at all levels with limited oversight.
Supervisory Responsibilities:
  • Depending on professional experience, manage, provide oversight and professional development support for 1-2+ additional attorneys to support North America healthcare law needs, including U.S. commercial and market access contracting.
Computer Skills:
  • PC, including MS Office Suite
Travel:
  • Up to 10%
Competencies:
 
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
 
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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