Counsel - Clinical Development, Medical & Regulatory Affairs

About the Department                                                                                                                                        

The Legal department is comprised of our Legal and Patents functions. We depend on our legal team to help drive growth and maintain the highest level of standards and practices across all of our legal efforts. It’s a tall order, which is why we only hire those who thrive on protecting the interests of our patients, employees and business, all while creating and implementing efficient and innovative solutions. As part of the team, you’ll work with employees across the organization to oversee legal matters and provide guidance on strategies that drive business and policy priorities and shape the reputation of Novo Nordisk Inc. (NNI). At Novo Nordisk, your skills, dedication and ambition will help us change lives for the better. In exchange, we’ll offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. Are you ready to realize your potential?

 

The Position

Responsible for providing legal support to the Clinical Development, Medical & Regulatory Affairs (CMR) organization at Novo Nordisk Inc. (NNI).  The position will provide full lifecycle advice and counsel to one or more therapeutic-area teams (e.g., Diabetes, Obesity, and Rare Disease) within CMR on matters relating to research and development, scientific exchange, and regulatory strategy and compliance.  This position offers unique exposure to cutting-edge work and a varied day-to-day experience, which will reward learning agility and creative business-lawyering skills.

 

Relationships

Reports to Managing Assistant General Counsel on the Clinical, Commercial & Corporate Law team (CCC Legal team) within NNI’s Legal Department.  Regularly interacts with Legal colleagues in other North American affiliates, ex-U.S. regional offices, and Novo Nordisk headquarters.  As part of the CCC Legal team, acts as an advisor to NNI’s CMR organization, but also collaborates with non-Legal stakeholders across the company, as required.  May also interact with external partners, vendors, industry associations and outside law firms.

 

Essential Functions

• 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, Scientific Publications and Strategic Resource Management, serving as the primary point of contact where assigned
• 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

 

Physical Requirements

0-10% overnight travel required.

 

Qualifications