Requisition ID 13619BR
Title Manager, Compliance Monitoring
Job Category Compliance
Job Description PURPOSE:
Monitor and audit 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 monitoring activities and audits of various company records, (ii) assisting with investigations related to audit findings and allegations of non-compliance with company policy, (iii) designing, developing and executing on a detailed project plan for quarterly and annual monitoring and auditing activities, (iv) presenting findings to the Chief Compliance Officer and senior management, and (iv) preparing regular audit reports and presentations in a form that is consistent with the NNI Compliance reporting and Corporate Integrity Agreement requirements.
RELATIONSHIPS:
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 Sales, Legal, Marketing, and various lines of business. The position will establish and maintain relationships with external consultants, Independent Review Organization, outside counsel, and others who might support NNI Compliance monitoring and auditing activities.
ESSENTIAL FUNCTIONS:
• Design, execute and manage against a Field Force monitoring plan to comply with the NNI Field Force Monitoring Program (FFMP) and Non-Promotional Monitoring Program (NPMP) in alignment with the Company Corporate Integrity Agreement
• Conduct and oversee detailed records review of field sales employees’ records and systems relating to interactions with healthcare professionals and institutions; specifically, perform comprehensive reviews of verbatims, sample distribution records, time and expense reports, inquiries relating to medical information, call notes, communications, and other relevant records and documentation; and use the information found to design and carryout further monitoring or auditing operations in an effort to detect potential or actual violations of company policies, as well as federal and state laws and regulations
• Manage external consultants and internal employees conducting live speaker program audits
• Review and address the results of such audits
• Manage documentation and address results from observations (ride-along's) of field sales representatives conducted to assess whether the messages delivered and materials distributed to Healthcare Professionals are consistent with applicable legal requirements and with NNI policies and procedures
• Conduct and oversee detailed review of documentation associated with consulting arrangements, and medical education grants to ensure compliance with NNI policies and procedures
• Develop and maintain knowledge and understanding of: NNI Diabetes and Biopharmaceutical products, industry regulations and guidelines (e.g. Federal Anti-Kickback Statute, False Claims Act), NNI policies, procedures, guidelines, and Corporate Integrity Agreement
• Establish and implement new systems and processes to monitor activities and further the NNI Compliance department monitoring program
• Prepare annual Corporate Integrity Agreement audit report regarding activities associated with the Field Force Monitoring Program and Non-Promotional Monitoring Program
• Prepare frequent reports and present results to the Chief Compliance Officer, managers in the relevant lines of business, and Senior Management
• 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
PHYSICAL REQUIREMENTS:
Approximately 10% overnight travel
DEVELOPMENT OF PEOPLE:
• 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
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelor's degree is required
• A minimum of 8+ years overall experience with a minimum of 5+ years of pharmaceutical or life sciences experience is required; compliance auditing and/or monitoring experience in the Pharmaceutical or life sciences industry is preferred
• Excellent written and verbal communication skills and organization skills are required
• Experience working with or under a Corporate Integrity Agreement preferred
• Must possess an in-depth knowledge and understanding of pharmaceutical industry regulations and guidelines (e.g. FDA, PhRMA Code, Federal Anti-Kickback, False Claims, etc.)
• Must possess an in-depth knowledge and understanding of pharmaceutical sales, marketing, and/or product related practices
• Strong written and verbal communication skills
• The ability to partner and collaborate effectively with stakeholders
• The ability to think objectively and use sound reasoning principles
• Supervisory experience required
Department North America - Compliance (3b)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%
Title Manager, Compliance Monitoring
Job Category Compliance
Job Description PURPOSE:
Monitor and audit 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 monitoring activities and audits of various company records, (ii) assisting with investigations related to audit findings and allegations of non-compliance with company policy, (iii) designing, developing and executing on a detailed project plan for quarterly and annual monitoring and auditing activities, (iv) presenting findings to the Chief Compliance Officer and senior management, and (iv) preparing regular audit reports and presentations in a form that is consistent with the NNI Compliance reporting and Corporate Integrity Agreement requirements.
RELATIONSHIPS:
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 Sales, Legal, Marketing, and various lines of business. The position will establish and maintain relationships with external consultants, Independent Review Organization, outside counsel, and others who might support NNI Compliance monitoring and auditing activities.
ESSENTIAL FUNCTIONS:
• Design, execute and manage against a Field Force monitoring plan to comply with the NNI Field Force Monitoring Program (FFMP) and Non-Promotional Monitoring Program (NPMP) in alignment with the Company Corporate Integrity Agreement
• Conduct and oversee detailed records review of field sales employees’ records and systems relating to interactions with healthcare professionals and institutions; specifically, perform comprehensive reviews of verbatims, sample distribution records, time and expense reports, inquiries relating to medical information, call notes, communications, and other relevant records and documentation; and use the information found to design and carryout further monitoring or auditing operations in an effort to detect potential or actual violations of company policies, as well as federal and state laws and regulations
• Manage external consultants and internal employees conducting live speaker program audits
• Review and address the results of such audits
• Manage documentation and address results from observations (ride-along's) of field sales representatives conducted to assess whether the messages delivered and materials distributed to Healthcare Professionals are consistent with applicable legal requirements and with NNI policies and procedures
• Conduct and oversee detailed review of documentation associated with consulting arrangements, and medical education grants to ensure compliance with NNI policies and procedures
• Develop and maintain knowledge and understanding of: NNI Diabetes and Biopharmaceutical products, industry regulations and guidelines (e.g. Federal Anti-Kickback Statute, False Claims Act), NNI policies, procedures, guidelines, and Corporate Integrity Agreement
• Establish and implement new systems and processes to monitor activities and further the NNI Compliance department monitoring program
• Prepare annual Corporate Integrity Agreement audit report regarding activities associated with the Field Force Monitoring Program and Non-Promotional Monitoring Program
• Prepare frequent reports and present results to the Chief Compliance Officer, managers in the relevant lines of business, and Senior Management
• 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
PHYSICAL REQUIREMENTS:
Approximately 10% overnight travel
DEVELOPMENT OF PEOPLE:
• 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
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelor's degree is required
• A minimum of 8+ years overall experience with a minimum of 5+ years of pharmaceutical or life sciences experience is required; compliance auditing and/or monitoring experience in the Pharmaceutical or life sciences industry is preferred
• Excellent written and verbal communication skills and organization skills are required
• Experience working with or under a Corporate Integrity Agreement preferred
• Must possess an in-depth knowledge and understanding of pharmaceutical industry regulations and guidelines (e.g. FDA, PhRMA Code, Federal Anti-Kickback, False Claims, etc.)
• Must possess an in-depth knowledge and understanding of pharmaceutical sales, marketing, and/or product related practices
• Strong written and verbal communication skills
• The ability to partner and collaborate effectively with stakeholders
• The ability to think objectively and use sound reasoning principles
• Supervisory experience required
Department North America - Compliance (3b)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%