Director - Government Accountability - Plainsboro, United States - Novo Nordisk

Novo Nordisk
Novo Nordisk
Verified Company
Plainsboro, United States

2 weeks ago

Mark Lane

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Mark Lane

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Description

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 interdepartment 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
  • Builds relationships
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