Executive Director Associate General Counsel Clinical and Corporate

Novo Nordisk US   •  

Plainsboro, NJ

Industry: Pharmaceuticals & Biotech


Not Specified years

Posted 182 days ago

This job is no longer available.

The Associate General Counsel- Clinical and Corporate Law role provides strategic legal counsel to global healthcare company on relevant issues involving application of U.S. law, regulations, and industry standards. Manage a team of attorneys and legal professionals supporting and enabling Novo Nordisk (NNI) business and operations.

Reports to the Corporate Vice President, Legal & Corporate Affairs. Acts as counsel for a particular customer group(s) or business function(s) and interacts with headquarters and other affiliates as required. May interact with government agencies, law firms, trade organizations and other external agencies, NN business partners and other key vendors. Effectively manages a team of licensed attorneys and other legal professionals.

Essential Functions
Serves on the Legal & Corporate Affairs Leadership Team. Manages team of attorneys and/or paralegals. Provides oversight and guidance on legal and regulatory matters handled by direct report. Proactively identifies risks and mitigating actions. Collaborates closely with other functional support groups in providing advice and counsel to customer group(s). Works closely with senior leadership from line of business in developing strategy and achieving objectives. Manages complex legal issues with minimal guidance. Oversees review and or/preparation of contracts or other legal documents, as needed. May retain, manage and assist outside counsel as needed. Keeps informed of new laws, regulations, and industry trends affecting the company, and assists with development of policies and training as needed. Upholds, acts as a role-model for, and coaches lawyers on the team to embrace the following approach to in-house counseling: Reliance on outside counsel is limited to only when necessary for unusual day-to-day issues. Ideally, there will be one lawyer per client or meeting (others may be consulted behind the scenes, but then only when necessary for narrow expertise). High levels of consistency in legal advice (actual and perceived by explaining differences to clients). Seek alignment up and across Legal, in advance of client meetings as much as reasonably possible. High levels of ownership, accountability and pride by lawyers with respect to their work. Actively seeking customer feedback on a continuous basis, actively listening and clarifying feedback, and acting in response as needed. Legal is viewed as a business partner and not an obstacle. Legal advice against engaging in a business practice is well-understood and respected by clients. Legal advice is clear as to the risk types, level, likelihood. Business-focused advice rather than abstract legal possibilities. Proactive, creative value-added legal role to help the business achieve its goals. Upholding and modeling ethical behavior and conduct at all times. Performs other duties as assigned by senior management. Manages a department budget

Physical Requirements
0-10% overnight travel required

Development of People
Ensure that reporting personnel have annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the Individual Development Plan (IDP) forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.


  • J.D. from accredited U.S. law school is required
  • 12+ years of relevant legal experiencepreferred
  • 7+ years of in-house branded pharmaceutical experience in an attorney position is preferred
  • People Management experience is required
  • Valid current state bar admission and in good standing is required
  • Ability to handle multiple projects simultaneously independently
  • Strong written and verbal communications skills – able to effectively collaborate and communicate with other client groups within the company, including Headquarters and other affiliates as required
  • Strong problem-solving skills. Demonstrates and exercises creativity and initiative
  • Strong leadership skills - able to effectively motivate and inspire a team
  • Recognized by peers in the industry as an expert in their field and periodic speaking at programs
  • Deep understanding of pharmaceutical business and Novo Nordisk products
  • Proactive, creative, innovative problem-solving and collaborative approach to counseling clients
  • Able to analyze NNI’s business for multiple potential legal issues, including as applicable:
    • OPDP, warning letter issues, off-label promotion, communications with HCPs, scientific exchange, press releases, publications, public presentations
    • Other FDA law enforcement by DOJ, States as to off-label promotion, etc.
    • Other FDA law and regulations, governing drug development, clinical studies, GxPs, responding to 483s, REMS, Recall, Pharmacovigilence reporting, clinical holds, informed consent
    • Anti-Kickback (Federal and State)
    • Products Liability
    • FTC, competition/competitor issues and risks
    • Consumer fraud
    • Practice of medicine
    • HIPAA and other data protection/collection issues
    • False Claims Act
    • PhRMA’s several industry codes for interactions with HCPs, conducting clinical trials, data transparency, clinicaltrials.gov, and related state and federal law and regulation
  • Must have sufficient legal expertise and experience to directly support and/or manage a staff who supports all aspects of NNI’s “CMR” (Clinical – Medical – Regulatory) department, including all documentation for clinical studies (contracts, CRO agreements, informed consent forms, IRB agreements, investigator agreements), full support of Regulatory (other than promotional review matters), R&D communications, R&D HCP engagements, Medical Information, HEOR, IIS, CME and other medical education, Medical Affairs (including field), Quality. Also supports Compliance, Finance/Tax, IT, SOX/SEC/Corporate, Supply Chain, Privacy, Digital Health and manages all legal process for Contract Management (including managing GSC and third-party legal reviewer vendors)