Senior Legal Counsel

In this role you will be acting as senior counsel to the Novartis UK business, advising senior business stakeholders on strategic legal questions and evaluating risk on existing and proposed business activities. You will also be acting as lead counsel on Novartis products within specified therapy area(s) within Novartis UK, advising on all legal questions and providing contextual guidance and solutions to the business with strong operational and business acumen. In addition, you will provide legal advice in support of Novartis Biomedical Research and Development activities in the UK.

Major accountabilities:

• Reporting to the Country Legal Head, approx. 60% of your responsibilities will include, but are not limited to:

• Actively participating in relevant UK therapy area leadership team discussions, risk evaluation and decision making.
• Negotiating and settling collaborative and joint working agreements between Novartis, the NHS and third party providers of goods and services.
• Providing legal support to wider Novartis UK initiatives as required, including providing support to in market and above brand projects as well as on internal and corporate projects requiring legal input.
• Acting as delegate to the UK Country Legal Head where required, representing Novartis UK Legal function in internal and external initiatives including leadership team discussions and industry group (ABPI) legal initiatives and consultation responses.
• Driving simplification and standardization projects and supporting the implementation of new tools and systems.
• Develop and implement appropriate policies, procedures, and guidelines and train and educate local business on these.
• Mentoring the development of Novartis UK Legal Counsels, providing advice, guidance and support where required.

• Reporting to the Head of R&D Legal, EMEA, approximately 40% of your responsibilities will include, but are not limited to:

• Providing legal counsel on activities and transactions in the UK in support of the Biomedical Research organization, which span across pre-clinical research and early-stage clinical development and include academic research collaborations, consortia membership, and issues involving data use and sharing, trade secret protection, contamination risks, publications, and scientific and data integrity.
• Providing legal advice on activities and transactions in the UK in support of the Development organization, including the start-up and conduct of clinical trials, and providing legal counsel on matters involving informed consent, IRB approval, patient recruitment, study site selection and payment, clinical vendor contracting, and related health authority regulatory issues.
• Adapt global R&D contracting templates and playbooks as needed to reflect local requirements.
• Counselling on regulatory issues involving development filing strategies, regulatory exclusivity, device requirements, trial and protocol transparency reporting, the handling and reporting of drug safety issues, fair market value requirements, Good Clinical Practices, and other drug development-related matters specific to the UK.

Essential Requirements:

• Qualified to practice as a solicitor or barrister in the UK and experience of advising on UK healthcare environment.
• Strong English language skills written and spoken.
• Significant experience of advising on activities connected to the promotion and sale of prescription medicines including compliance with ABPI Code.
• Familiarity with medicines development activities, from early stage clinical development to pre-launch activities including development filing strategies and regulatory exclusivities.
• Understanding of the structure and set-up and operation of clinical trials in the UK and their associated activities and the legal issues surrounding these.
• Working within complex multi-functional teams on complex projects with multiple stakeholders.
• Negotiating and drafting complex high value commercial partnership agreements, sales agreements and other commercial arrangements.

Benefits and rewards:

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