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BRIAN PERRELLA
CHERYL PEDOTA
Prabhdeep Singh
USA

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Manager - Ethics & Compliance Monitoring & Auditing Job

Date: Apr 10, 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
This position is responsible for executing against the Novo Nordisk Inc. (NNI) Ethics and Compliance (E&C) Department’s annual Monitoring & Auditing (M&A) strategic plan. This role will: conduct monitoring activities and audits of various company records, manage the development and implementation of remediation & mitigation processes, assist with investigations related to findings and allegations of non-compliance with Company policy, prepare regular reports and presentations in a form that is consistent with internal and external reporting requirements.


Relationships
Reports to the Associate Director – E&C Monitoring & Auditing or designee. Closely collaborates with NNI’s in-house legal counsel, leaders across lines of business, and is a member of cross-functional teams throughout NNI. The position will also interact with external customers including Health Care Professionals (HCP), third party/external vendors, and external consultants. This position may interact with government officials. This position may manage employees in NNI’s Global Servicing Center in Bangalore.


Essential Functions
  • Support the Associate Director, E&C Monitoring & Auditing in facilitating and raising awareness of the Ethics & Compliance program while fostering accountability for compliance throughout the organization
  • Maintain understanding of laws and regulations, enforcement actions and evolving practices relevant to pharmaceutical compliance and proposes updates to ethics & compliance program, as appropriate
  • Identify, analyze, and mitigate potential business and ethics risks to the organization
  • Support the development and manage the implementation of a robust ethics and compliance monitoring and auditing plan
  • Develop and maintain knowledge and understanding of: (1) Novo Nordisk disease state and products (e.g. Diabetes, Obesity, BioPharm), (2) industry regulations and guidelines (e.g., laws and regulations regarding pharmaceutical advertising and promotion, Federal Anti-Kickback Statute, False Claims Act, etc.), Novo Nordisk policies and procedures, and government reporting requirements as needed
  • Develop and manage protocols, guidelines and associated internal communication and documentation related to E&C testing and monitoring
  • Develop and manage the remediation and mitigation process on for the M&A team
  • Review records and systems relating to interactions with healthcare professionals and institutions, conduct field monitoring visits and monitor various company-sponsored activities to ensure adherence with relevant laws, regulations, industry codes, and company policies
  • Support E&C audits for North America and NN affiliates (e.g. NNRCSI, LatAm, etc.) in support of annual auditing plan and/or ad hoc audits as requested
  • Review and follow-up on suspected areas of non-compliance and collaborate with NNI Ethics & Compliance teams as needed
  • Collaborate with compliance colleagues and line of business to help develop and implement remediation and mitigation plans
  • Prepare reports and presentations summarizing monitoring and auditing findings and remediation for management and external government agencies as requested

Physical Requirements
20-30% 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 (e.g. MBA, JD, PMP)
  • Demonstrated knowledge and understanding of the Anti-Kickback Statute and False Claims Act, Food & Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals, corporate integrity agreements, PhRMA code, and other relevant reporting requirements
  • Compliance monitoring and auditing experience in the Pharmaceutical or life sciences industry is strongly preferred
  • Experience working under a government agreement (e.g. Corporate Integrity Agreement, Consent Decree, etc.) is required
  • 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
  • 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
  • Uncompromising ethics and high standard of personal integrity
  • Ability to work proactively and independently with minimal supervision
  • Proficiency in Microsoft Office Suite
  • Supervisory experience preferred

Novo Nordisk is an Equal Opportunity Employer - M/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: 59762BR
State/Provinces: Plainsboro
Job Category: Legal & Compliance


Nearest Major Market: New Jersey

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