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BRIAN PERRELLA
CHERYL PEDOTA
Prabhdeep Singh
USA

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Manager - Ethics and Compliance Monitoring & Auditing Job

Date: Nov 21, 2018

Location: Plainsboro, NJ, US

Company: Novo Nordisk

About the Department
At Novo Nordisk, we’re committed to building the best Compliance team in the pharmaceutical industry. Operating at the highest ethical standards and ensuring adherence to corporate and legal regulations, the Compliance 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, Compliance 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 processes, assist with investigations related to audit findings and allegations of non-compliance with Company policy, preparing regular reports and presentations in a form that is consistent with internal and external reporting requirements.


Relationships
Reports to the Associate Director – 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, 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 ethics risks to the organization
  • Support the development and manage the implementation of a robust health care compliance monitoring and auditing plan
  • Develop and maintain knowledge and understanding of: (1) Novo Nordisk Diabetes, Obesity, and BioPharm disease state and products, (2) industry regulations and guidelines (e.g., laws and regulations regarding pharmaceutical advertising and promotion, Federal Anti-Kickback Statute, False Claims Act, PDMA), 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
  • Manage the full cycle of assigned review processes (e.g. management of third party vendors)
  • 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, Business Ethics & Compliance Office (BECO), LatAm) 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 quarterly and ad hoc reports and presentations summarizing monitoring and auditing monitoring

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 and Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals, corporate integrity agreements, PhRMA code, and other relevant reporting requirements
  • Compliance auditing and/or monitoring experience in the Pharmaceutical or life sciences industry is required
  • Experience working under a government agreement (e.g. CIA, DPA, Consent Decree) 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 /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: 59043BR
State/Provinces: Plainsboro
Job Category: Legal & Compliance


Nearest Major Market: New Jersey

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