The Corporate Counsel, R&D reports to the Associate General Counsel and is a key member of the team for the Legal & Compliance Department. The Corporate Counsel, R&D is responsible for supporting and advising clinical development, regulatory strategy, pharmacovigilance and other R&D clients on a broad array of issues relating to FDA pharmaceutical regulations, GxP requirements, product development, product labeling, interactions with healthcare professionals and patients, anti-trust, anti-kickback, competitor issues, compliance issues, regulatory policy and industry developments and issues. This position will also be responsible for coordinating with the Legal & Compliance Department’s contracting team to support the contract needs of the R&D departments, as needed.
The Corporate Counsel, R&D:
- Provides clear, actionable and business-savvy legal advice to clients within the R&D organization on matters pertaining to processes and procedures in support of clinical trials, cooperative studies and similar arrangements, with a particular emphasis on the relationships between and among sponsors, CROs, sites/investigators and vendors, as well as matters relating to regulatory strategy, pharmacovigilance, and other functions within the R&D organization.
- Provides strategic advice and counsels clients on the legal implications of research and development projects, regulatory matters, business development matters, healthcare compliance issues, and activities involving interactions with healthcare professionals, healthcare organizations, research institutions and patients.
- Serves as primary legal support on process and contractual matters relating to clinical trial disclosures and data sharing arrangements and provides input as needed on clinical trial transactional matters.
- Provides subject matter expertise, and legal support and guidance, on the development and application of standard operating procedures and related supporting procedural documents for R&D activities.
- Works as part of a matrix team at Jazz supporting the R&D departments, handling clinical, regulatory, quality and pharmacovigilance and drug safety matters.
- Advises clients on a broad range of legal and contractual matters to support Jazz’s global R&D business, including informed consent documents, correspondence with institutional review boards/ethics committees, advisory board and HCP engagements and other agreements.
- Assists with and supports legal and corporate due diligence activities on strategic transactions, as requested.
- Educates clients regarding relevant legal updates, industry and regulatory developments, industry best practices, and risk mitigation solutions.
- Works extensively and collaboratively with Jazz colleagues in Europe and the ex-U.S. business with respect to contract alignment and local compliance and disclosure requirements.
- Assists with supporting corporate compliance function; helps create and deliver policies, procedures and training to R&D teams.
- Drives increased efficiency, coordination, and effectiveness of legal advice, processes, and support to meet the needs of the R&D functions and the global business.
- Partners with Legal & Compliance Department colleagues in executing and enhancing corporate and department objectives.
- Supervises outside counsel as required.
Required Knowledge, Skills, and Abilities
- Demonstrated broad understanding of pharmaceutical industry and regulatory enforcement environment including familiarity with regulations and regulatory guidance by the U.S. Food & Drug Administration and the European Medicines Agency relating to clinical trials and pharmacovigilance, is required.
- Demonstrated experience working in a matrixed business environment, managing multiple commitments while prioritizing conflicting demands, maintaining focus on corporate objectives and providing quality customer service.
- Demonstrated ability to independently identify, analyze and render legal advice on complex business issues and general corporate matters.
- A global business enterprise view, with recognition of the potential operational implications of corporate legal issues within a region or country.
- Excellent critical thinking skills; ability to work through complex issues, including those with significant strategic risk to company.
- Ability to work both independently and collaboratively, with a record of establishing professional credibility and developing strong working relationships with executive management and colleagues across the organization.
- Demonstrated experience identifying and resolving legal and compliance issues quickly and effectively.
- Excellent verbal and written communication skills.
- Periodic travel throughout the United States and Europe is required.
Required/Preferred Education and Licenses
- Juris Doctorate (J.D.) degree and admission to the Bar of at least one state and eligible to practice as in-house counsel in California or Pennsylvania.
- 5-7 years' of experience supporting clients in the pharmaceutical industry, preferably at a multinational company and/or a reputable, highly rated law firm, or a combination of both, with a substantial amount of professional experience dedicated to advising on FDA regulatory compliance, Good Clinical Practice (GcP), and other matters relating to clinical trials and research and development activities.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.