Legal Senior Counsel Commercial Hybrid

Job Description

Legal Senior Counsel, North America Commercial & Development Legal Group (Hybrid)

Why Join Us?

Vertex is a transformative biotechnology company that creates new possibilities in medicine to transform diseases and improve people’s lives and it is seeking a solutions-oriented healthcare attorney to provide proactive strategic and tactical legal support to our business.

The company currently has four drugs on the market that treat the underlying cause of cystic fibrosis and one drug on the market that is a cell and gene therapy treatment for sickle-cell disease and transfusion-dependent t β-thalassemia.

It has also developed a deep pipeline, investing billions of dollars into R&D over the past two decades.

As Legal Senior Counsel, you’ll be a part of Vertex’s highly respected Legal and Compliance Department at the company's world headquarters in Boston, MA.

The Department is committed to a trusting and collaborative culture where we value growth and development. We engage proactively with our business colleagues to truly understand them and deliver results for our company and for patients.

This is a hybrid position that requires three days per week on site in the Boston office.

Job Summary

The person in this role will provide expert advice and counseling to Vertex’s North American business on a broad array of strategic and tactical projects within a highly regulated environment.

This position will report to the Executive Director & Head Therapeutics Counsel and will be responsible for providing legal support to business partners in various departments across the organization, such as Disease Strategy Teams, Global and North America Marketing, North America Sales, Patient Advocacy, Patient Support, Health Economics And Outcomes Research, Global Medicines Development and Medical Affairs (GMDA), Field Training, Market Research, Business Analytics, Regulatory Affairs, Public Affairs, and Corporate Communications.

The ideal candidate will have prior experience counseling prescription drug companies on legal issues relating to patient support, advertising and promotion, scientific exchange, and interactions with health care professionals.

Key Responsibilities

Provide Advice and Counsel to Business Partners

• Advise business partners on various Commercial, Medical, Healthcare Economic, and Pipeline initiatives in a way that advances the company’s strategy while addressing legal risks and protecting the company’s integrity and reputation
• Provide legal advice and counsel on advertising and promotion strategies and activities, including : the use of social media;
• dissemination of scientific information; product development and labeling; pharmacovigilance; product liability; healthcare fraud and abuse;

and other matters relevant to the development, manufacture and commercialization of prescription drugs

• Serve as a member of various cross-functional teams, including the Global Commercialization Team, Communication Review Committee, Medical Review Committee, and Label Review Group
• Stay abreast of and communicate to the organization significant legal developments, legislation and regulatory rulings that may affect the company in the area of commercial healthcare law.
• Act as a subject matter expert on matters relating to healthcare law and related business operations, staying abreast of evolving healthcare legislation and regulations and the enforcement landscape

Contribute to the Legal & Compliance Department

• Work collaboratively with Compliance colleagues to develop and implement training to internal business partners on key policies, procedures, practices and requirements for healthcare and related legal compliance and educate business partners about current enforcement trends.
• Participate in various Legal & Compliance Department projects and initiatives, including committees such as Talent & Development;

Culture, Diversity & Inclusion; and Pro Bono

Share information and knowledge through group presentations and individual discussions with peers and managers

Qualifications, Professional Skills, and Preferred Experience

• JD from an ABA accredited law school
• Member of a state bar
• 8+ years post-JD experience advising on legal matters in a life sciences space, whether in a law firm or in-house in the biopharmaceutical industry, or both
• Outstanding ability to effectively communicate sound legal advice to lawyers and non-lawyers alike, coupled with a strong understanding of business needs
• Excellent analytical and problem-solving skills
• Subject matter expert advising on statutes, regulations, and guidance documents applicable to commercial, development and medical affairs activities, including : research and interpretation of the Food, Drug, and Cosmetic Act;

FDA regulations and guidance; federal and state anti-kickback statutes; OIG guidance documents and advisory opinions; the False Claims Act; and the PhRMA Code

• Experience in supporting a company transitioning from pre-commercial to commercial-stage
• Experience serving on a promotional and medical review committee

Personal Attributes

Self-starter and life-long learner with a strong work ethic and excellent interpersonal skills who

• Is a strong communicator
• Enjoys working collaboratively and cross-functionally on teams, as well as independently
• Proactively solves problems and makes decisions
• Thrives in a fast-paced and dynamic environment
• Is eager to take on new challenges
12 days ago