About the Department We depend on our Legal team to help drive growth and maintain the highest level of legal standards and corporate governance practices. 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 legal solutions. As part of the team, you’ll work with employees across the organization to oversee legal matters and provide guidance on communications 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 Provide legal counsel to global healthcare company on relevant issues involving application of U.S. law, regulations, and industry standards. The role will be dedicated to providing legal guidance to a broad spectrum of internal stakeholders (Clinical, Medical & Regulatory (CMR)).
Relationships Reports to Senior Corporate Counsel.
Provide legal support to Clinical Trial Management team, CMR Operations (including functions such as Product Safety, Medical Education, Med Info, and Quality), and Regulatory Affairs
Draft, review and negotiate contracts, particularly clinical trial agreements and service agreements
Oversee clinical trial contract review process, including substantial oversight of individuals involved in contract review process (e.g., paralegals, Global Service Center resources)
Assist with the development or revision of policies and relevant training as needed. Keep abreast of regulatory developments affecting Company and generate legal strategies to resolve issues
Anticipate potential obstacles in obtaining desired regulatory outcomes and work with key stakeholders to generate and implement response strategies
Assist Quality organization and Regulatory Affairs in handling for audits and inspections by regulatory authorities, responding to Food and Drug Administration (FDA) Form 483s and warning letters, developing remediation work plans, and conducting market withdrawal/recall/field action analyses
Advise on compliance with post-market regulations, including adverse event reporting and pharmacovigilance, recalls, and good manufacturing practices
Draft comments on proposed laws and regulations, FDA guidance documents, and industry group policy positions impacting clinical development
Physical Requirements Travel 0-20%. Position located in Plainsboro, New Jersey (NJ).
A Bachelor's degree, JD degree and state bar admission required
Minimum of 8 years legal experience
Some government agency and in-house experience preferred
Experience advising on laws, regulations, and industry standards impacting the life sciences industry required
Demonstrates comprehensive knowledge and understanding of legal concepts, principles, and practices
Displays expertise in FDA regulatory law including: Good Clinical Practices (GCP); Good Manufacturing Practices (GMP); Good Pharmacovigilance Practices (GVP); PhRMA/BIO codes; Risk Evaluation and Mitigation Strategy (REMS) requirements
Has a deep understanding of the pharmaceutical and biotechnology industry and business model
Possesses strong communication and time management skills, the ability to handle multiple projects simultaneously, and effective collaboration with other functional support groups and line of business
Demonstrates strong ability to collaborate, work independently, and utilize problem- solving skills, creativity, and initiative. Strong commitment to ethical standards