Description

Job Description

General Summary:

Vertex Pharmaceuticals is recognized for its innovative medicines and global commitment to improving patient outcomes. As Vertex grows internationally, we seek a Legal Senior Counsel to provide expert legal leadership and advice to the Hematology business unit at international headquarters level as well as in regulatory matters for our current portfolio of products and in preparation for launches of our pipeline assets across our International markets.

The Legal Senior Counsel will provide solutions-oriented legal advice and support on a broad array of strategic and tactical matters within a highly regulated environment; demonstrating a high degree of autonomy representing significant risk and complexity, working closely with senior leaders and cross-functional teams.

Key Duties and Responsibilities:

• Advises internal clients on legal matters in a way that advances the company's strategy while addressing legal risks and protecting the company's integrity and reputation.
• Guardian of best corporate practices.
• Monitor and interpret developments in global regulatory frameworks related to pharmaceuticals and medical devices.
• Collaborate with regulatory teams on Marketing Authorization Applications (MAA), product approvals, labeling, and compliance strategies.
• Draft, review, and negotiate contracts with hospitals and treatment centres, supporting the activation of hematology treatment centres (ATC) and patient access programs, with attention to local and international regulatory requirements.
• Lead legal efforts in the activation of treatment centres, resolving regulatory issues and ensuring agreements are robust and compliant.
• Advise on emerging regulatory issues-working closely with pharmacovigilance, risk management team and healthcare compliance teams.
• Act as the subject matter expert with respect to European and UK pharmaceutical regulatory matters providing solution-oriented advice
• Support audits, investigations, and regulatory inspections in international markets.
• Proactively identify opportunities to streamline legal and regulatory processes
• Subject matter expert on matters within the area of accountability, staying abreast of evolving regulations and the enforcement landscape, analyzing trends and communicating effectively within the organization.
• Serves as a member of various cross-functional teams, generally comprising senior company personnel.
• Exhibits a breadth of knowledge across multiple disciplines, sees the big picture and puts legal risk and solutions in context.
• Introduces and drives strategic actions.
• Drives and contributes to various department and cross-functional governance and process improvement projects.
• Participates in various other Legal & Compliance Department projects and initiatives.

Knowledge and Skills:

• Expert knowledge of the laws, regulations and industry standards applicable to the area of responsibility.
• Thrives in detailed regulatory analysis and problem-solving.
• Experience in international regulatory submissions, product launch, and post-market compliance.
• Strong expertise in contract law, healthcare regulations, and negotiation with hospitals and treatment centres.
• Lead legal advisor for the Heme BU, with growth potential as the unit expands.
• Strategic vision, autonomy, and collaborative mindset.
• Significant understanding of business drivers.
• Excellent analytical and complex problem-solving skills, sound judgment.
• Outstanding ability to effectively communicate sound legal advice and influence clients, including senior company leaders, to take appropriate actions.
• Ability to work cross-functionally and independently.
• Ability to work in a fast-paced and dynamic environment.
• Ability to drive strategic action.
• Ability to create buy-in and trust.

Education and Experience:

• Qualified lawyer with a JD or LLM
• Typically requires significant years of post-qualification experience advising on legal matters in a life sciences space, whether in-house or in a law firm, or both, or the equivalent combination of education and experience

#LI-SG1

#LI-Hybrid

Flex Designation:
Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com