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BRIAN PERRELLA
CHERYL PEDOTA
Prabhdeep Singh
USA

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Senior Manager - Government Accountability Job

Date: Aug 12, 2019

Location: Plainsboro, NJ, US

Company: Novo Nordisk

About the Department
At Novo Nordisk, we’re committed to building the best Ethics and Compliance (E&C) team in the pharmaceutical industry. Operating at the highest ethical standards and ensuring adherence to corporate and legal regulations, the E&C 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, E&C 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
The position is responsible for managing daily operational activities related to the Ethics & Compliance (E&C) Departments government reporting obligations including but not limited to Transparency Reporting (e.g. local, state, federal requirements for transfers of value, price reporting, disclosure requirements, sharp/drug takebacks), Novo Nordisk Inc (NNI) government agreements (e.g. Corporate Integrity Agreement (CIA)) regulatory requirements (e.g. Prescription Drug Marketing Act (PDMA) reporting) and the systems that support these processes.


Relationships
This position reports to the Director E&C Government Accountability, and frequently interacts with other E&C functional areas (e.g. Business Partners (BP), Education). Regularly interacts, and provides direction to, information technology, Commercial Effectiveness, Clinical Operations and Marketing Effectiveness. Collaborates with Legal for assumptions and opinions. Manages external customers including Health Care Professionals (HCP), third party/external vendors, and external consultants. Interacts with government officials. Provides direction to NNIs Global Servicing Center in Bangalore. Supports North America and serves on global projects. Serves on technical and other subcommittees.


Essential Functions
  • Supports the Director - E&C Government Accountability in facilitating and raising awareness while fostering accountability for Ethics & Compliance program throughout the organization
  • 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
  • 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
  • Manages the review and timely reporting of all government requirements while understanding local and global impact
  • Supports the Director in 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
  • Manages 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)
  • Forwards risks and issues to appropriate E&C and line of business (LoB) teams in a timely manner
  • 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
  • Supports NN affiliates (e.g., NNCI) with implementing and maintaining a government accountability program
  • Responsible for creating and executing an Organizational Change Management (OCM) Plan for Government Accountability Programs, as needed
  • Conducts training to employees and third party vendors to timely communicate new government reporting requirements or updated NNI interpretations
  • Supports the government accountability budget (e.g. forecasting expenditures, reporting variances, and ensuring responsible spending)
  • Responsible for ensuring that Compliance senior management is informed of compliance issues in a timely manner and encourages the flow of information between Compliance colleagues and lines of business
  • Additional responsibilities with government reporting or departmental operational impact as assigned
  • Supports Director with NN A/S collaborations regarding government reporting requirements and integration of systems/data
  • Point of contact for systems updates, upgrades and recommendations from LoB
  • Recommends enhancements to systems, processes and technologies for government reporting
  • Represents E&C on Change Advisory Boards and/or other systems boards as requested

Physical Requirements
0-10% overnight travel required


Qualifications
  • A Bachelor 's degree from an accredited institution required
  • A minimum of 8 years combined pharmaceutical, legal, regulatory, and compliance experience required OR a minimum of 6 years' experience required if accompanied by an advanced degree or certificate (MBA, JD, PMP, etc.)
  • Demonstrates functional knowledge and understanding of the Anti-kickback Statute, the False Claims Act, Food & Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals, government corporate integrity agreements, PhRMA and federal and state aggregate spend reporting requirements
  • Experience working under a government agreement is required (e.g. CIA, 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
  • Supervisory experience preferred

Novo Nordisk is an Equal Opportunity Employer /F/Veteran/Disability/Sexual Orientation/Gender Identity.

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.

Requisition ID: 60223BR
State/Provinces: Plainsboro
Job Category: Legal & Compliance


Nearest Major Market: New Jersey

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