As a counsel in Greenwich’s U.S. Legal Department, the attorney will provide legal advice and support across the lifecycle of Greenwich’s products, including pipeline, commercial and medical affairs functions. Supported teams include research and development, brand sales and marketing, commercial strategic and operational functions, medical affairs teams, and corporate functions.
Location: San Diego / Carlsbad, CA
Provide legal direction on FDA promotional matters, healthcare fraud and abuse laws, product liability, antitrust, privacy and other laws impacting the commercialization of biotech products;
Counsel on appropriate relationships with healthcare professionals, patients, managed care entities, academic institutions, and government entities;
Support the contracting function in the United States. Draft, review, negotiate and interpret a wide range of commercial, R&D and drug clinical development related agreements, including informed consent, clinical trial, master service, and consulting agreements, licensing and research collaborations, and other strategic alliances for quality assurance, drug development, clinical manufacture and supply.
Advise on business strategies, tactical plan development and implementation, and other business issues, including development of legal assessments and solutions-oriented risk mitigation strategies;
Proactively inform business clients of important legal, enforcement and other industry developments; actively respond to inquiries and requests for advice.
Provide legal support to outside counsel on designated practice areas/business clients; consult with outside counsel on discrete issues.
Collaborate across global Legal Department as necessary to support business clients/practice area.
JD with bar admission
5+ years of relevant experience, a substantial portion of which includes in-house experience at a pharmaceutical company or law firm with pharmaceutical clients and substantial client contact and varied responsibility.
Knowledge in a range of legal areas of relevance to the company's operations, including:
Federal Food, Drug and Cosmetic Act and related regulations, the False Claims Act, and laws related to fraud and abuse in the pharmaceutical and biotech industries
commercial and R&D contracting
Excellent oral and written communications skills.
Demonstrated ability to:
deliver sound and concise legal advice in a solution-oriented manner and in the context of evolving business strategy,
contribute actively to the legal department by proactively developing opportunities to enhance practice group efficiency,
consistently support the need to meet strict compliance requirements, and effectively present to group audiences.
Experience with trademark & brand defense preferred.
About Greenwich Biosciences
GW Pharmaceuticals (GW), along with its U.S. subsidiary Greenwich Biosciences, is a pioneering global biopharmaceutical company that has established a world-leading position in cannabinoid science and medicines over the last 20 years. GW’s mission is to transform the lives of seriously ill patients through developing and delivering rigorously tested cannabis-derived pharmaceutical medicines. Our aim is to develop regulatory-approved medicines with documented safety and efficacy profiles that are manufactured to the highest standards.
GW’s research efforts initially focused on the unmet needs of patients with Multiple Sclerosis (MS), while in recent years the Company has focused on helping children and adults with severe, life-threatening forms of epilepsy. Looking to the future, GW’s deep scientific knowledge and extensive body of research is enabling the Company to explore new therapeutic areas, including neurology, oncology, psychiatry and autism spectrum disorders.
Since the Company was founded in 1998, more than 6,000 patients have been involved in GW’s clinical trials globally. GW has collected more than 80,000 years of human safety data, been featured in more than 80 p...eer-reviewed publications, and generated high-quality evidence which has appeared in the New England Journal of Medicine and The Lancet. In 2018, TIME magazine named GW one of the 'Top 50 Genius Companies of 2018 That Are Inventing the Future'? in recognition of this work.
We are looking for talented individuals who are passionate about making a difference in the lives of our patients. Greenwich Biosciences’ headquarters are in Carlsbad, CA. Our Parent company GW Pharmaceuticals, PLC, was founded in 1998 and is based in the UK.