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Director - Government Accountability

Employer
Novo Nordisk
Location
Plainsboro, NJ
Start date
May 20, 2024

View more

Discipline
Quality, Quality Assurance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work

Job Details

About the Department 

At Novo Nordisk, we’re committed to building the best Ethics, Compliance & Privacy (ECP) team in the pharmaceutical industry. Operating at the highest ethical & privacy standards and ensuring adherence to corporate and legal regulations, this team is constantly called upon to design and implement creative solutions to complex issues. From training on new procedures, to auditing against local and corporate policies, to reporting compliance-related issues, ECP keeps us accountable every step of the way as we develop life-changing therapies and bring them to market. At Novo Nordisk, you will be part of a company respected equally for its financial results and its business ethics. Are you ready to make a difference?

 

The Position

This position supports the Corporate Compliance & Privacy Officer in setting the strategy and program requirements for the Corporate Compliance and Government Accountability Programs. The position is responsible for managing and operationalizing the program and team, related to the Ethics, Compliance & Privacy Department’s Government Accountability Program, including but not limited to Transparency Reporting (e.g. local, state, federal requirements for transfers of value, price reporting, disclosure requirements, sharp/drug takebacks), Representative and Organizational licensure (e.g., OR rep licensure), NNI government agreements (e.g. Corporate Integrity Agreement (CIA)) regulatory requirements (e.g. PDMA reporting) and the systems that support these processes (e.g. the transparency system).  This role also is responsible for operationalizing systems and processes to meet new and emerging government obligations.  This position is also involved in working cross-functionally to align on a compliant strategy for complying with complex requirements such as price transparency or affordability obligations. Serves as an empowered contact in the Ethics & Compliance (E&C) Department, helping to ensure that the E&CDepartment takes a holistic view of risk management, considering broad organizational priorities as well as external insights.  

 

Relationships

This position reports to the Corporate Compliance & Privacy Officer for North America Ethics & Compliance.  Frequently interacts with other E&C Leaders and functional areas (e.g. BPs, Education).  Regularly interacts, and provides direction to, information technology, Commercial Effectiveness, Clinical Operations and Marketing Effectiveness.  Strong collaborations with senior leaders from Legal, Finance, Operations and Market Access as well as others across the North America and Global organization.  Manages external customers including Health Care Professionals (HCP), third party/external vendors, and external consultants.  External stakeholders include government agencies, outside counsel, consultants, vendors and pharmaceutical industry professionals.  Provides direction to NNIs Global Servicing Center in Bangalore.  Supports North America and serves on global projects.  Provides guidance and oversight to team members as requested.
 

Essential Functions

  • Supports the Corporate Compliance & Privacy Officer in facilitating and raising awareness while fostering accountability for Ethics & Compliance program throughout the organization:
    • Manage the Government Accountability Program and Team, which is designed to meet planned and ad hoc reporting and response obligations, to various government requirements.  These may include: state and federal transparency requirements, sharp/drug takeback requirements, price reporting disclosures, PDMA requirements and any NNI specific government agreements.
    • Manages the development of the annual plan to meet NNIs government obligations including but not limited to local, state and federal transparency requirements, sharp/drug takeback requirements, price reporting disclosures, PDMA requirements and any NNI specific government agreements
    • Sets direction for coordination, review and timely reporting of all government requirements (e.g. CIA, if applicable, federal, state and local reporting, REMS requirements, etc.) while understanding the local and global impact to the business
    • Oversees creation and continued maintenance of government reporting protocols and assumption documents to support accurate filings and internal documentation
    • Responsible for supporting government attestations and the transactional and systems work that supports these attestations (e.g. data review)
    • Represent the Government Accountability team and the Leadership Team as a member of various inter-department project work groups
    • Conducts training to employees and third party vendors to timely communicate new government reporting requirements or updated NNI interpretations
  • Maintains understanding of laws and regulations, enforcement actions and evolving practices relevant to pharmaceutical ethics & compliance and proposes updates to Ethics & Compliance program, as appropriate
  • Responsible for advising and leading teams to manage implementation of relevant information technology systems and applications to drive systematic solutions and improvements for Corporate Compliance requirements in close collaboration with NN DD&IT
  • Builds relationships and influences government agencies and peer companies, thought leader in industry groups
  • Oversees projects across global and North America organization to support the corporate strategy and manage risk of the organization
    • Supports NN affiliates (e.g., NNCI, East Coast Hub) with oversight/maintenance of standards to meet government obligations and E&C program
    • Supports or Manages NN A/S collaborations regarding government requirements and integration of systems/data
  • Represents E&C on Steering, Change Advisory Boards and/or other systems boards as requested
  • Manages relationships with business-critical external vendors.  This includes drafting and reviewing contracts, collaborating on RFPs, and supporting systematic review of resource allocation
  • Responsible for leading cross-functional compliance task forces, who’s goal is to assess impact and oversee the company’s compliance with new and changed regulatory obligations related to Corporate Compliance. 
  • Informs management of ethics & compliance issues in a timely manner while encouraging the flow of information between colleagues and lines of business. Actively works to identify, analyze, and mitigate potential business ethics and other risks to the organization comprehensive mitigation and remediation plans in conjunction with E&C risk team to ensure correct strategies are in place to continually improve processes and data integrity 
    • Creates comprehensive mitigation and remediation plans in conjunction with E&C risk team to ensure correct strategies are in place to continually improve processes and data integrity
  • Serves as a role model of the Novo Nordisk Leadership Competencies and leads the Government Accountability team in alignment with theses and the NN WAY: 
    • Direct manager of individuals on the Government Accountability Team

 

Physical Requirements

10-20% overnight travel required.

 

Qualifications

  • A Bachelor 's degree from an accredited institution is required. 
  • A minimum of 10+ years combined pharmaceutical, legal, regulatory, and compliance experience required Or a minimum of 8 years experience if accompanied by an advanced degree or certification (MBA, JD, PMP, etc)
  • Demonstrates functional knowledge and understanding of the Anti-kickback Statute, the False Claims Act, FDA rules and regulations regarding the promotion of pharmaceuticals, government corporate integrity agreements, PhRMA and federal and state aggregate spend, and price transparency reporting requirements.
  • Experience working under a government agreement is required (e.g. CIA, DPA, Consent Decree)
  • Demonstrates strong interpersonal skills and ability to influence at all levels of the organization
  • Excellent communication and organization skills
  • Excellent project management skills to oversee and drive project execution
  • Ability to manage multiple projects concurrently and collaborate across several functional areas.
  • The ability to think objectively and use sound reasoning principles.
  • Knowledge and experience with pharmaceutical aggregate spend solutions and data associated with promotional and clinical data, preferred.
  • Ability to manage multiple projects to completion meeting internal and external deliverables with high degree of accuracy
  • Excellent communication skills (written and verbal), strong report writing skills and organization skills are required
  • Proven ability to manage local and international resources in alignment the organization’s 
  • Supervisory experience required
  •  

    We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

     

    At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

     

    Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

     

    If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

    Company

    Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk.com.

    Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R&D, from early research through late-stage clinical development. We are building for the future by creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.

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    Company info
    Website
    Phone
    617-612-6200
    Location
    75 Hayden Avenue
    Lexington
    MA
    02421
    US

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