Counsel - Clinical Development, Medical & Regulatory Affairs

Role Summary

Provide legal support to the Clinical Development, Medical & Regulatory Affairs (CMR) organization at Novo Nordisk Inc. The role will provide full lifecycle advice and counsel to one or more therapeutic-area teams on matters relating to research and development, scientific exchange, and regulatory strategy and compliance. This position offers exposure to cutting-edge work and a varied day-to-day experience, rewarding learning agility and creative business-lawyering skills.

Responsibilities

• Provide high-quality legal support relating to Novo Nordisk research and development activities, including sponsored clinical trials, collaborations, and non-interventional studies
• Advise and counsel on Medical Affairs strategy and tactics, including scientific exchange, therapeutic-area development, and proposed interactions with healthcare professionals and other stakeholders within the scientific ecosystem
• Serve as a subject-matter expert on Medical Affairs activities and the principles of scientific exchange, with the ability to clearly communicate the application of relevant legal/regulatory frameworks onto a varied set of proposed initiatives and tactics
• Draft, negotiate and review a broad set of contractual agreements while ensuring compliance with applicable laws, regulations and industry guidance
• Counsel on research and development-related requirements, including those related to GxP compliance, interacting with study sites and personnel, and the informed consent process
• Liaise with and advise CMR functions like Product Safety, Publications and Independent Medical Education
• Demonstrate knowledge of, and ability to communicate about, laws, regulations and industry standards governing the CMR organization’s functions, including fraud-and-abuse laws, FDA regulations, ICH guidelines GxP requirements, pharmacovigilance, and relevant privacy laws and regulations
• Provide general legal support, when required, to other North American affiliates, including on a broad range of collaboration activities, research-operations matters and strategic-business initiatives
• Collaborate with Legal colleagues and NNI’s Ethics, Compliance & Privacy function, including the North America Privacy Office
• Keep informed of new laws, regulations, and industry trends affecting the company, facilitating the proactive identification of risks and development of mitigation strategies
• Assist with the design and implementation of policies, processes, and training
• Perform other duties as assigned by senior management
• Provide legal support with limited oversight and guidance from managing attorney
• May retain, manage and assist outside counsel as needed for non-routine matters
• Serve as an excellent teammate and collaborator, but be comfortable making decisions and providing agentic leadership, often with limited information

Qualifications

• Required: A Juris Doctor (JD) degree or an internationally recognized equivalent and state bar admission
• Required: 5+ years of experience in a law firm or in-house legal department
• Required: In-depth knowledge of applicable state and federal laws and regulations
• Required: Demonstrated experience making and communicating risk assessments, identifying and resolving legal and regulatory issues, and making real-time decisions under pressure
• Required: Proven track record as a strong team player with ability to work collaboratively and cross-functionally in a complex organizational structure
• Required: Ability to work independently, proactively and pragmatically, with a focus on results
• Required: Strong problem-solving skills with creativity and initiative
• Required: Advanced written and verbal communications skills, with the ability to collaborate and communicate with stakeholders at all levels

• Preferred: Relevant experience providing legal advice to life sciences/pharmaceutical industry on research and development

Education

• Juris Doctor (JD) degree or internationally recognized equivalent; state bar admission

Additional Requirements

• Up to 10% overnight travel required