We are seeking a seasoned life sciences attorney to lead our small but mighty FDA Regulatory Law group and to join our whip-smart and 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 to deliver results for our company and for patients. If you thrive in a fast-paced, hands-on, and team-oriented environment where you can have a big impact on the organization, we d love to talk to you!
The individual in this position will be the point person for providing strategic and solutions-oriented legal advice to a broad spectrum of internal clients, including senior leadership, from the following functions: Clinical Development, Real World Evidence, Clinical Trial Transparency, Translational Medicine, Publications, Managed Access, Quality, Regulatory Strategy, Regulatory Policy, Safety, and Global Marketing. This role will be highly visible and will have the opportunity to directly contribute to Vertex s success, and thus candidates must display a high level of executive presence and leadership competencies. The position has one direct report (an attorney) as well as responsibility for managing a budget. This position will report to the Vice President of Commercial and Regulatory Legal.
Advising business leaders on strategies and tactics in a way that advances the company s business while addressing legal risks and protecting the company s integrity and reputation.
Providing practical and timely advice on various corporate initiatives and activities, such as clinical development of investigational compounds (including design of studies to support regulatory approval), regulatory strategy for new products and line extensions, Hatch Waxman issues and life cycle management, design and use of real-world studies to support regulatory submissions, investigator meetings, expanded access programs, publication issues, FDA inspections, GxP compliance, recalls, clinical trial reporting, EMA Policy 70, and clinical trial data sharing.
Helping to draft responses to proposed laws and regulations, FDA guidance documents, and industry group policy positions.
Providing regulatory law support for transactions, including conducting regulatory due diligence, negotiating key regulatory terms, and supporting post-transaction integration activities.
Providing regulatory law support to brand attorneys on advertising and promotion issues.
Keeping abreast of regulatory developments affecting clients (e.g., cell and gene therapies, mobile medical applications, track and trace) and anticipating potential obstacles in obtaining desired regulatory outcomes.
Providing oversight and guidance on matters handled by direct report.
Participating in various Legal & Compliance Department projects and initiatives (e.g., Culture Committee, Pro Bono & Community Engagement Committee, Talent & Development Committee, Diversity Committee, offsite planning, strategic planning).
JD from an ABA accredited law school and member of a state bar.
Minimum of 12 years experience providing FDA regulatory advice to pharmaceutical, biotechnology, or medical device companies, whether in-house or at a law firm with a nationally recognized FDA life sciences practice
Specific expertise required in statutes, regulations and guidance concerning: GxP, drug development, regulatory submission standards, expedited programs for serious conditions, promotion and scientific exchange, Hatch-Waxman, Orphan Drug Act, DQSA, clinicaltrials.gov reporting, and fraud and abuse.
Solid working knowledge of other laws, regulations, and industry standards that affect the development and commercialization of pharmaceutical and biotechnology products, including FCPA, competition law; OIG guidelines and opinions; Sunshine Act/transparency laws; privacy laws, product liability, and industry standards (e.g., PhRMA guidelines, ICMJE and GPP standards, ACCME guidelines).
Consummate team player with excellent judgment and interpersonal skills.
Ability to constructively counsel and influence clients in making the right decisions, and to make tough calls.
Capacity to simultaneously handle a variety of complex legal matters with minimal guidance
Demonstrable experience taking ownership of issues and providing timely, actionable advice.
Exceptional written, oral and presentation skills.