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Manager, Compliance Audits Job

Hiring Company Industry: Biotech/Pharma
Number of Employees: 1 - 100 Employees
Total Compensation: Doe
     - Base Salary: Doe
Location: Princeton, NJ
Position Filled

Requisition ID 9018BR
Title Manager, Compliance Audits
Job Category Compliance
Job Description PURPOSE:
Audit and monitor Company and individual adherence to Novo Nordisk (NNI) policies, guidelines, Corporate Integrity Agreement, and other defined federal and state laws and requirements. This role will have responsibilities for: (i) conducting audits and monitor activities against company policies and procedures, (ii) executing against a work plan for quarterly, annual, and ad-hoc audit and monitoring activities, (iii) developing audit protocols and Compliance related audit tools, (iv) preparing regular audit reports and presentations, (v) working with line of business to support remediation of audit findings or non-compliance with company policy, (vi) performing follow-up to audit findings that required corrective actions, (vii) communicate and present audit results to senior management and the line of business.

This position reports to the Senior Manager, Compliance Monitoring & Auditing. Individual will interact daily with Compliance staff and internal counterparts in other NNI business areas including Legal, Finance, Human Resources, NNAS Group Internal Audit, and various lines of business. The position will establish and maintain relationships with external consultants, outside counsel, and others who might support NNI Compliance auditing and monitoring activities.

 Participate in annual risk assessment to review and prioritize annual audit plan
Recommend which types of auditing and monitoring activities should be part of the Compliance audit and monitoring plan
Plan compliance audits by engaging line of business and other relevant stakeholders, preparing audit protocol, and planning document request and work paper documentation structure
Execute and manage against an audit plan related to various functions within Sales, Marketing, Clinical, Medical, & Regulatory, Finance, and other lines of business through each area of the audit life cycle: plan, develop, conduct, assess, report, and remediate
Direct external consultants and specialists as appropriate when using external resources to support a compliance audit
Prepare audit reports to be presented to line of business and senior management on the results of auditing and/or monitoring performed
Review and follow-up on suspected areas of non-compliance with company policies, procedures, or industry regulations
Work with NNI Compliance Investigations personnel as appropriate during the investigation and development of corrective actions related to incidents of non-compliance or violation of NNI policies
Provide assistance to NNI colleagues in other departments as appropriate for compliance audit issues
Interact with NNAS Global Internal Audit and support global audit team during annual internal audits
Manage regularly scheduled monitor activities and other ad-hoc audit requests
Work with other Compliance Monitor & Auditing team members to develop analytics to track metrics and develop trending reports
Implement new systems and processes to audit activities and further NNI Compliance monitoring and auditing program
Develop and maintain knowledge and understanding of industry regulations and guidelines (e.g. PhRMA Code, Federal Anti-kickback statute, False Claims Act, OIG Guidance, FDA and other state/federal regulations), Novo Nordisk policies, procedures, guidelines, Corporate Integrity Agreement NNI Diabetes and Biopharmaceutical products
Remain current with developments in auditing and the pharmaceutical industry

Approximately 15% overnight travel

Ensure that reporting personnel have 3P forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process
Ensure that IDP forms include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility
Manage the application and communication of all NNI policies, procedures, and Novo Nordisk Way

A Bachelors degree from an accredited four year university or equivalent experience degree required
An internal audit or CPA credential highly desirable
A minimum of 8+ years overall experience with a minimum of 5+ years in public accounting, an internal audit environment or both required
Experience in auditing Regulatory/Compliance within Pharmaceutical or life sciences industry is preferred
Knowledge and understanding of pharmaceutical industry regulations and guidelines (e.g. FDA, PhRMA Code, Federal Anti-Kickback, False Claims, etc.) is preferred
Proven ability to effectively and efficiently manage audit and monitoring projects and possess a detailed understanding of the full auditing life cycle
Excellent written and verbal communication skills and organization skills are required
Strong interpersonal skills and the ability to work closely with all levels of management, staff, external auditors, regulators, audit committee and others
Supervisory experience preferred
Department North America - Compliance (1ba)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Master's Degree or equivalent experience
Percent Travel 10 - 20%

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